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Job DescriptionLycia Therapeutics is a biotechnology company using its proprietary lysosomal targeting chimera (LYTAC) platform to discover and develop best-in-class therapeutics that degrade extracellular and membrane-bound proteins. These proteins drive a wide range of difficult-to-treat diseases, including autoimmune and inflammatory conditions. Lycia was established in 2019 in collaboration with academic founder and Nobel Laureate Carolyn Bertozzi, Ph.D., professor of chemistry and HHMI investigator at Stanford University. In May 2024, Lycia Therapeutics completed a $106.6 million Series C financing to advance its pipeline of LYTAC extracellular protein degraders to the clinic. Lycia is headquartered in South San Francisco. Visit https://lyciatx.com/ for more information. Position Summary Lycia is seeking a highly motivated, innovative, and collaborative clinical development leader to join our team in advancing our pipeline of LYTAC degraders and help establish Lycia as the industry leader in endosomal-lysosomal degradation and delivery. The successful candidate is expected to have a strong drug development track record of advancing programs from early through mid- and late-phase clinical development.The candidate will be expected to drive the study design, study implementation, data analysis, safety monitoring of mid- and late-phase clinical trials in close partnership with early phase / translational development group and the research organization. The successful candidate will be instrumental in providing medical leadership and expertise to help guide the direction and actively support the advancement of our pipeline.The candidate will have a strong background in medicine, recognized expertise in their therapeutic area and strong leadership abilities, and a passion for driving innovation and excellence in a start-up biotech company. The role will report to the Chief Medical Officer.Primary Responsibilities: • Lead the development, execution, and interpretation of mid- to late-stage development plan in close collaborative partnership with early development / translational leader, cross-functional representatives, and research group to support clinical development and/or regulatory approval., • Provide oversight of medical monitoring of clinical trials in partnership with CRO representatives and consultants to ensure pharmacovigilance and safety-related activities are appropriately managed according to GCP and regulatory guidelines in a timely manner., • Provide medical support related to the development of medical and/or relevant scientific sections of clinical study and/or regulatory documents (e.g., study protocol, investigators brochure, informed consent forms, clinical study reports, statistical analysis plans, safety updates / annual safety reports, responses to Health Authorities and/or Ethics Committees / Institutional Review Committees). Participate in safety monitoring boards (e.g., Data Safety Monitoring Boards) as needed., • Ensure compliance with regulatory requirements and guidelines throughout the product lifecycle, including interactions with regulatory agencies and participation in development of regulatory documents for submissions to Health Authorities., • Contribute to the development and execution of program strategic plans and initiatives to maximize the value and impact of our portfolio., • Collaboration with the Lycia Executive Committee members, early development / translational medicine leader, internal cross functional team members, as well as partner with contract research organizations (CROs), investigators and study site staff, and external consultants to advance multiple drug candidates, including into mid- and late-stage development., • Working with cross-functional teams to develop program relevant documents (e.g., target product profiles, materials for internal governance, board meetings, publication planning material, advisory board documents) as needed to support program initiatives., • Provide clinical and scientific leadership and guidance to internal teams and external stakeholders, including investigators, key opinion leaders (KOLs), and scientific advisors., • Partner with the CEO, CMO, program and/or functional leads, on behalf of clinical development leadership, the planning and execution of advisory boards with external KOLs, in close coordination with the early translational medicine leader, • Build and maintain effective relationships with key external stakeholders, including healthcare providers, patient advocacy groups, and professional societies., • Lead project teams in the successful implementation of key clinical development programs to ensure that program timelines and budgets are met., • Ensures timely, clear, and accurate communication and interpretation of study results to facilitate productive discussion and effective decision making., • May serve as the company representative or subject matter expert in meetings with external stakeholders (business partners/collaborators, vendors, investigators, regulatory agencies, patient advocacy organizations, payers)., • Member of clinical and scientific leadership team that will work effectively and collaboratively with other departments and cross-functional teams, and contribute to building a positive, team-oriented culture., • Contribute to the pipeline strategy, including input on program prioritization, portfolio trade-offs, and organizational build-out of the clinical development function as Lycia scales.Qualifications:, • MD or equivalent with training/experience, • Minimum of 15+ years of clinical development experience; small to midsize biotech company experience strongly preferred., • Proven track record of leadership in the successful development and implementation of Phase 2 and Phase 3 clinical trials to support regulatory submission (e.g., BLA, NDA)., • Experience in writing clinical sections of regulatory documents and direct interaction with the FDA/health authorities. Strong knowledge of nonclinical drug development, FDA, and ICH guidelines and GCP regulations; experience in NDA and/or BLA submissions is preferred., • Experience in supporting identification, working with and oversight of CROs and vendors a track record of timely and successful delivery of clinical studies., • Experience collaborating and managing consultants., • Must thrive working in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans and recommendations., • Demonstrated ability to translate strategy into action. Excellent analytical skills, ability to communicate complex issues in a simple way, and ability to orchestrate plans to resolve issues and mitigate risks., • Demonstrated ability to build and lead high functioning, collaborative and driven teams (both internal and external), and mentoring direct reports and/or junior cross-functional colleagues as applicable., • Ability to build trust and strong collaborative relationships with both internal and external stakeholders., • Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with other clinicians, scientists, managers, peers, and staff., • Outstanding organizational and interpersonal skills, and outstanding ability to manage relationships and influence others., • Excellent strategic thinking, problem-solving, and analytical skills, • Excellent written and verbal communication skills., • Experience in immunology & inflammation and autoimmune indications, preferred., • Willingness to be both a strategic leader, critical thinker, and hands-on problem solver and willing to operate and execute at all levels., • Strong ability to communicate and establish effective working relationship with external stakeholders (e.g., investigators, collaborators, scientific advisors, CROs, and corporate partners)., • Able to work in a small, nimble organization across key functions., • Highly organized and detailed oriented., • Prepare and attend internal governance meetings., • Make meaningful contributions to business development related activities as needed., • Willingness to travel up to 15% of the time.The expected base salary range for this role is $360,000-$420,000. We encourage candidates of all levels to apply as there is often flexibility on job title and responsibilities. Compensation will be based on a variety of factors, including experience, qualifications and internal equity. Lycia offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Lycia and other biotech companies have recently noticed an increase in email and social media scams targeting job candidates in our industry. Please note Lycia will post any legitimate job openings directly on our website or through our recruitment partner, Lever. If you wish to verify the legitimacy of a job opening, you may contact us. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description POSITION SUMMARY: Reporting to the Chief Medical Officer (CMO), the Vice President, Clinical Development provides executive leadership for the company’s clinical research and development activities within designated therapeutic areas and/or programs. The Vice President is responsible for the strategic planning, execution, and oversight of clinical trials and related data generation activities in support of Rigel’s product development and regulatory objectives. The Vice President, Clinical Development serves as a senior leader within Clinical Development, accountable for clinical trial execution, data integrity, regulatory readiness, and cross-functional alignment. The role partners closely with Biometrics, Clinical Operations, Regulatory Affairs, Medical Affairs, and Drug Safety to ensure clinical programs are executed in accordance with corporate strategy, regulatory requirements, and medical standards. The Vice President, Clinical Development contributes to portfolio-level decision-making and represents Clinical Development in internal governance forums and selected external engagements. Salary Range: $336,000 to $405,000 ESSENTIAL DUTIES AND RESPONSIBILITIES: Clinical Strategy & Execution • Provide executive oversight for the design, planning, and execution of clinical development programs across assigned therapeutic areas or assets., • Lead the development and implementation of clinical development plans aligned with Rigel's product strategy, registration pathways, and lifecycle management objectives., • Ensure high-quality execution of clinical trials, including protocol development, data collection, analysis, and reporting in compliance with GCP, regulatory, and medical standards., • Oversee preparation and review of key clinical documents, including protocols, Investigator's Brochures, clinical study reports, and regulatory submission materials. Organizational & Cross-Functional Leadership • Serve as a senior Clinical Development representative on cross-functional project teams, governance committees, and internal review bodies., • Partner with Clinical Operations and external CROs to ensure efficient trial execution, appropriate medical monitoring, and adherence to safety and quality standards., • Collaborate with Drug Safety to ensure ongoing evaluation of safety data and integration of pharmacovigilance considerations into clinical programs., • Contribute to enterprise decision-making through participation in portfolio reviews, investment discussions, and development governance forums. Regulatory & External Engagement • Support interactions with global Health Authorities by contributing to briefing packages, responses, and strategic positioning for assigned programs., • Engage with external experts, investigators, key opinion leaders, and advisory boards to inform clinical strategy and execution., • Provide clinical development input to Business Development activities, including due diligence for potential in-licensing or partnering opportunities. Strategic Contribution • Translate emerging clinical data into actionable insights to inform development decisions and portfolio strategy., • Support the CMO in shaping long-term clinical development capabilities, processes, and talent. KNOWLEDGE AND SKILL REQUIREMENTS: • M.D. degree; advanced knowledge in hematology/oncology required. Board certification in hematology or oncology preferred, • Minimum of 8 years of experience in clinical research or drug development (Phase 1 through 4) in an academic or industry environment; =6 years in an industry (pharmaceutical or biotech) setting, • Experience leading or supporting interactions with global Health Authorities and contributing to regulatory strategy, • Demonstrated ability to evaluate, interpret, and communicate complex scientific and clinical data to inform development and portfolio decisions, • Thorough knowledge of Good Clinical Practice, statistics, and clinical trial design, • Proven executive-level leader with experience driving clinical development strategies and delivering high-quality outcomes across multiple stakeholders, • Significant experience working cross-functionally within a matrixed organization and establishing productive scientific partnerships with external experts, • Excellent executive communication (verbal and written) and presentation skills, with the ability to influence internal and external stakeholders WORKING CONDITIONS: • PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus., • WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required. Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.

SUMMARY/JOB PURPOSE: In collaboration with the Exelixis clinical teams, the primary role is to lead and execute early/late stage clinical trials for oncology products in development. Participates in the design/planning of clinical studies and helps with the interpretation of study results. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators for research studies. Responsibilities also include adverse event reporting and safety responsibilities monitoring. Monitors adherence to protocols and determines study completion. Essential Duties And Responsibilities: Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice. Act as medical monitor for company sponsored trials. Support project teams with therapeutic area specific information. Collaborate with internal safety group in analyzing and reporting of safety data from clinical trials. Analyze and interpret other clinical trial data and prepare reports for regulatory agencies and publication. Interact with key opinion leaders and investigators in relevant disease specific area. Ensure consistency of scientific and development strategies for oncology products in development. Maintain the highest level of scientific and clinical knowledge in relevant disease specific area. Supervisory Responsibilities: None May on case-by-case basis supervise employees, both directly and indirectly through a dotted line structure or via other subordinate supervisors. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: MD (board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential) required with a minimum of 8 years of post-residency experience. Equivalent combination of education and experience Experience/The Ideal for Successful Entry into Job: Drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry. Note: Individuals with extensive academic experience but without experience in the pharmaceutical industry may be considered Hands-on experience in the design, execution, and reporting of controlled clinical trials in oncology. Participated in clinical oncology studies with molecular targeted or immunological therapies. Understanding of basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics). Knowledge/Skills: Proven ability to effectively work in a cross-functional/matrix environment Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways. Develops technical and/or business solutions to complex problems. Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results. Ability to develop and maintain relationships with significant key opinion leaders. Strong interpersonal, influencing, presentation, and written and verbal communication skills Strong organizational and time management skills JOB COMPLEXITY: Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors Works on abstract problems across functional areas of the business Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results. Regularly interacts with executives and/or major customers. #LI-HG1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $283,000 - $402,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

SUMMARY/JOB PURPOSE: The Clinical Trials Manager (CTM), Clinical Operations, coordinates the activities associated with the evaluation, initiation, and management of clinical trials. This position is responsible for overseeing the execution of clinical trials, collaborating with cross-functional teams, performing oversight activities of Contract Research Organizations (CROs), and providing operational support to the Study Delivery Lead (SDL). ESSENTIAL DUTIES AND RESPONSIBILITIES: • Manages clinical trials, including those conducted through Contract Research Organizations (CROs), • May participate in developing and recommending operational strategies for clinical trials in collaboration with cross-functional teams, • Responsible for at least one geographical region and manages/oversees one to three external vendors within a specific scope (e.g., Lab), • Engages with CROs, vendors and sites for ongoing trial execution, including relationship management and quality / performance oversight, • Provides CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc., • Attends and contributes to internal Study Delivery Team (SDT) meetings, including contribution to agenda preparation, • Coordinates the preparation, conduct, and presentations at Investigator Meetings, • Assists Study Delivery Team (SDT) and CRO in feasibility assessments and site selection, • Assists with study protocol development, reviewing of informed consent forms, case report forms, monitoring plans, and other study materials, • Maintains regular contact with relevant departments (e.g., Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.), • Provides oversight to CRO to ensure site adherence to protocol and Good Clinical Practice (GCP) guidelines, • Proactively identifies and communicates study issues, provides risk mitigation strategies, and escalates issues as needed, • Provides support for adherence/compliance to study plans (e.g., Verification of Performance (VOP), • Ensures oversight of regulatory and essential documents, • Supports and oversees the development of study plans and documents (e.g., VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals), • Coordinates the design, format, and content of study guides and subject instructions, • May participate in strategic governance discussions as required (e.g., SAB, BOD, DT, TAT, DSC, DOC), • May support / be responsible for site and vendor invoice reviews, • Reviews and provides oversight of study trackers and metrics, • Provides oversight to development and review of study documents (i.e. Protocol, ICF, CRFs, IRT specifications, Inv product labels, etc), • May be responsible for department strategic initiatives or process improvements, • May serve as a mentor and provide training to Sr. Clinical Trial Specialists (CTS) SUPERVISORY RESPONSIBILITIES: • None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: • BA/BA/BSN in biological sciences or related field and a minimum of 7 years of related experience; or,, • MS/MA/MSN in biological sciences or related field and a minimum of 5 years of related experience; or,, • PhD/PharmD in biological sciences or related field and zero or more years of related experience; or,, • Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: • Typically requires a minimum of 7 years of related experience in life sciences, including 5 years in experience in clinical research Knowledge/Skills: • Experience in either starting a study up, maintenance phase, or study close-out, • Experience with development of prospective site-selection criteria, • Protocol development experience, • Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures, • Familiar with advanced concepts of clinical research, • Ability to deal with time demands, incomplete information or unexpected events, • Experience in interactions with outside vendors, e.g., CROs and contract labs, • Experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations, • Demonstrated ability to write and present clearly using on scientific and clinical issues terminology, • Strong organizational and planning skills, • Strong interpersonal skills and communication skills (both written and oral), • Ability to work effectively in a team/matrix environment, • Ability to understand technical, scientific, and medical information, • Demonstrated success in problem-solving JOB COMPLEXITY: • Ability to anticipate and resolve problems, • Ability to write and present clearly, especially on scientific and clinical issues, • Ability to work effectively in a team/matrix environment, • Demonstrated professional collaboration skills, • Understands departmental processes and implements solutions to address any task-related challenges, • Identifies and escalates issues that may have a broader impact DESIRED BEHAVIORS: • Ability to study, analyze and understand new situations and business problems and identify appropriate solutions, • Operationally excellent and drives others towards excellence, • Resilient in the context of a rapidly changing environment, • Works independently to meet objectives and completes tasks within established timelines., • Organized with a systematic approach to prioritization EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS: • We drive for results, so patients can survive and thrive., • We are resilient in the face of adversity, and tireless in advancing our science., • We celebrate our long history of prolific drug discovery and rigorous drug development., • We unite to launch innovative medicines for difficult-to-treat cancers., • We exist to give people hope - one drug, one patient at a time., • We are Exelixis. LIVES THE EXELIXIS CORE VALUES DAILY: • Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way),, • Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results), • Excel for Patients (Innovate to design solutions and remove barriers to show how much we care) WORKING CONDITIONS: • Travel may be required up to 20% in support of clinical study activities DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class. If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $136,000 - $192,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

SUMMARY/JOB PURPOSE: Applies extensive technical expertise and experience to provide written and verbal recommendations on statistical issues, design and conduct of clinical trials of all phases. Uses initiative to develop, maintain and share knowledge of the theory and application of current statistical methods appropriate for data analysis and clinical trial design. Works collaboratively with clinicians, data managers, biostatisticians, statistical programmers, and medical writers in the planning, conduct and analysis of clinical trials. Essential Duties And Responsibilities: • Work with project team members on developing clinical protocol. Review CRFs, CRF edit checks and CRF completion guidelines. Author statistical analysis plan, TLF shells and Table of contents for outputs to be generated. Review ADaM specifications and verify primary and secondary efficacy endpoints., • Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications., • Effectively manage CRO to ensure high-quality deliverables within timeline and budget., • Oversee programming of ADaMs and TLFs for the study., • Responsible for one or more studies with concurrent tasks and timelines., • Participate in the validation/QC of key study endpoint analysis and submission deliverables., • Apply appropriate regulatory guidelines to the projects. Supervisory Responsibilities: • None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: • MS/MA degree in related discipline and a minimum of 9 years of related experience; or,, • PhD in related discipline and a minimum of 5 years of related experience; or,, • Equivalent combination of education and experience., • May require certification in assigned area. Experience/The Ideal for Successful Entry into Job: • Experience in oncology and study Phases I-III highly preferred., • Experience in Biotech/Pharmaceutical industry preferred., • Experience with managing CROs in the conduct of clinical trials., • Experience with statistical applications and clinical data management procedures in the conduct of clinical trials., • Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings. Knowledge/Skills: • Knowledge of appropriate regulations, industry standards and guidance documents., • Ability to interact effectively with biostatistical, data management, operations, and clinical personnel from CROs and companies collaborating with Exelixis., • Developed/reviewed SDTM/ADaM specifications, • Strong SAS programming knowledge., • Guides the successful completion of major programs, projects and/or functions., • Leads or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing., • Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways., • Develops technical and/or business solutions to complex problems., • Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results., • Performs a variety of complicated tasks with a wide degree of creativity and latitude., • Has complete understanding and wide application of technical principles, theories, concepts, and techniques., • Has good general knowledge of other related disciplines., • Applies strong analytical and business communication skills. JOB COMPLEXITY: • Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles., • Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results., • Creates formal networks involving coordination among groups. #LI-JP1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $166,000 - $236,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

SUMMARY/JOB PURPOSE: Provide oversight for the execution of oncology data management activities at the program level (for an indication or for multiple studies within an indication) from study start up through to regulatory submission. In collaboration with cross-functional teams, external partners, and support Data Managers, may serve as the lead study data manager for a large, complex trial or multiple, smaller studies. Will support CDM process improvement initiatives. Participate in staff recruitment, onboarding, training, and mentoring. * This position is located at Exelixis beautiful headquarters overlooking the bay in Alameda, CA. Full relocation provided ESSENTIAL DUTIES AND RESPONSIBILITIES: • As the main point of contact to Study Team, work collaboratively with cross-functional team members to meet project deliverables with quality and per agreed timelines, • Lead the planning and execution of data management activities on assigned studies, • Ensure all Data Management study documents are developed and archived, • Establish and lead the Data Working Group (DWG) for assigned study, • Develop and maintain Data Management timelines, • Track and manage progress towards data deliverables through effective metrics tracking, analysis, and reporting, • Effectively identify and mitigate risks to Data Management deliverables, • Identify and resolve data handling related issues, • Provide a high level of expertise in data management to support clinical studies., • Provide clear verbal or written information and hands-on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status., • Develop and execute procedures for data quality review and data acceptance prior to data analyses and/or database lock., • Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA /WHO-DD coding., • Support the transfer, locking, and archiving of study databases. Manage scheduling and time constraints across multiple projects., • Prepare recommendations for new or improved processes for data management and data flow., • Work collaboratively with cross-functional stakeholders to ensure project deliverables and timelines are met., • Direct and oversees activities of Data Management staff assigned to studies and tasks within projects, • Perform project level resource management in conjunction with CDM Management, • Lead electronic submission activities for Data Management as appropriate., • Participate in selecting outsourcing partners for assigned studies including:, • Input to Request for Proposal (RFP), • Review proposals, • Participate in evaluation/audits and capabilities presentations, • Review project scope of work documentation, • Provide oversight of vendors providing Data Management services, • Develop and execute study specific training of staff within a project, • Lead or participate in CDM process improvement initiatives, • Promote and be an advocate for CDM internally and externally., • Direct the activities and hold accountable junior data managers and/or data review teams SUPERVISORY RESPONSIBILITIES: • No direct reports EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: • BS/BA degree in related discipline and a minimum of 11 years of related experience; or,, • MS/MA degree in related discipline and a minimum of 9 years of related experience; or,, • PhD in related discipline and a minimum of 5 years of related experience; or,, • Equivalent combination of education and experience., • May require certification in assigned area. Experience/The Ideal for Successful Entry into Job: • Typically requires a minimum of 9 years of related experience and/or combination of experience and education/training., • A minimum of 7 years of clinical data management experience is also required in the pharmaceutical industry or clinical trials., • A minimum of 4 years in a project leadership role, • Experience with Electronic Data Capture (EDC) is required and experience with Interactive Voice or Web Response Systems (IVRS/IWRS) is preferred., • Demonstrated experience leading data management teams is preferred Knowledge/Skills: • The ability to problem solve and have people/project leadership skills., • Knowledge of GCP is essential., • General knowledge of FDA regulations that govern the execution of clinical trials and Electronic Data Capture (EDc) systems required, • Expertise in CDASH/CDISC standards preferred., • Has extensive experience in relevant industry/profession and area of specialization., • Uses professional concepts and company objectives to resolve complex issues in creative and effective ways., • Identifies and implements methods and procedures to achieve results., • Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing., • Performs a variety of complicated tasks with a wide degree of creativity and latitude., • Has complete understanding and wide application of technical principles, theories, concepts, and techniques., • Has good general knowledge of other related disciplines., • Applies strong analytical and business communication skills., • Demonstrated Data Management Project Management skills, • Excellent verbal and written communication skills and interpersonal skills are required. JOB COMPLEXITY: • Utilizes appropriate CDM concepts and resources to solve moderately complex technical CDM issues, • Works independently and consults with management on decisions affecting project delivery as appropriate, • Drives the completion of milestones associated with specific projects. Failure to achieve results or erroneous decisions or recommendations will cause delays in program schedules and may result in the allocation of additional resources., • Regular inter-organizational and outside contacts on routine matters., • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors., • Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results., • Networks with key contacts outside own area of expertise WORKING CONDITIONS: #LI-JD1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $163,000 - $231,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

SUMMARY/JOB PURPOSE: The Executive Director, GCP/GVP QA, is accountable and responsible for defining and implementing an end-to-end GCP/GVP QA strategy and direction, as well as implementing and maintaining an effective cross-functional GCP/GVP Inspection Readiness program. This position leads and develops a team of GCP QA professionals and collaborates with functional embedded compliance roles to assess company compliance and quality across GCP and GVP functions, systems, and activities. Integrates quality by design throughout functional and cross-functional GCP and GVP processes, and a risk-based approach to associated audits; supports cross-functional Quality Risk Management (QRM) processes to identify, track, and mitigate risk within GCP/GVP, develops, tracks, and trends key metrics to inform risk-based decisions, and collaborates with functional representatives to manage patient safety and clinical data integrity and reliability risks through support of functions and QA oversight activities. In addition, this position drives GCP/GPV Inspection Readiness initiatives internally and serves as the coordinator for the Inspection Readiness Governance Council (IRGC), partners with clinical study teams and CROs to conduct inspection preparation activities at Clinical Sites, and collaborates with Compliance QA on the conduct of GCP/GVP mock inspections, internal, and clinical site audits. Manages regulatory health authority clinical trial-related sponsor inspections, primarily as a moderator. Identifies and resolves issues for continuous improvement, in strong partnership with internal functions (e.g., Clinical Development, Clinical Operations, Regulatory Affairs, Global Patient Safety, Clinical Data Management, Biostatistics, and clinical study teams) and external partners. Delivers training and provides feedback to cross-functional subject matter experts (SMEs) on how to perform and respond to questions or requests during an inspection. Aligns key GCP/GVP QA strategies with business goals and understands the global regulatory compliance landscape and how that translates to regulatory expectations in the context of inspection management. Represents QA as the QA Partner (Primary Point of Contact) responsible for building and maintaining solid relationships with functional leaders and other key stakeholders, speaking One Voice for Quality, and represents QA in an outwardly and business-facing capacity, in strategic and decision forums, to provide and ensure delivery on company strategic goals and deliverables. Delineates and communicates roles and responsibilities clearly and effectively, manages communications in a productive and transparent way, and leverages established relationships to influence behavior across the organization. In the context of clinical sponsor inspections, serves as the GCP/GVP moderator who can respond to first-level questions, triage questions and requests to the appropriate SMEs, manage complex questions, defend company processes and positions properly, and facilitate a smooth inspection process with successful outcomes. ESSENTIAL DUTIES/RESPONSIBILITIES: Establishes and maintains the GCP/GVP Inspection Readiness program and supports the development and revision of functional and cross-functional policies and procedures; supports auditing and compliance monitoring of non-clinical and clinical trials in accordance with applicable health authority regulations and guidelines. Responsible for the overall health of the GCP/GVP Inspection Readiness program, collaborating with cross-functional stakeholders to identify GCP/GVP issues and risks, and creating a risk log and an overall scorecard that can be applied to manage and mitigate risks. Develops QA GCP/GVP strategy for team within QA with clear goals and objectives that align with business needs; manages complex issues leveraging benchmarking data and experience, escalates rapidly when needed, and drives for resolution. Partners with Compliance QA on Clinical Site Audits; uses the outcomes to inform risk-based decisions and development or refinement of metrics designed to identify potential noncompliance at Exelixis-sponsored clinical trial sites. Assesses new regulations and guidances to determine if any changes need to be made to internal GCP and GVP processes and/or if any training needs to be developed and delivered. Oversees and coaches GCP/GVP QA team members through regular individual touchpoints and team meetings. Develops a GCP/GVP QA playbook that incorporates past experiences and challenges to train team members to identify common clinical trial issues, such as protocol deviations or potential serious breaches, that could impact patient safety and/or data reliability. Serves as a GCP/GVP change management agent, establishing and maintaining a culture of quality and compliance. Reviews and approves, as applicable, non-clinical and clinical trial documents, including clinical study protocols and amendments, risk management plans, etc., and regulatory agency submissions, as applicable. Partners with key stakeholders, including Clinical Operations, to define functional and QA oversight of the CROs and other critical vendors. In partnership with functional stakeholders, identifies and manages issues and risks, making sure to document such issues and risks in a risk log so that risk assessment activities are captured, and awareness of key risks is properly disclosed to the relevant parties. Interprets and applies ICH E6 (R3), Good Clinical Practice (GCP) ICH regulatory guidelines and directives for clinical trials involving human subjects, in line with the goals and principles of ethics in clinical trials, compliance with the study protocol, informed consent, and protection of confidentiality of the test subject, and quality assurance in clinical trial management. Provides leadership and technical expertise. Demonstrates cross-functional leadership, establishes strong relationships, and leverages influencing skills and expertise to drive change and foster a culture of quality. Provides guidance, coaching, and development to the QA team. SUPERVISORY RESPONSIBILITIES: Leads a team of GCP/GVP quality professionals. Leads a cross-functional team, the IRGC. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: BS/ B.Sc preferably in the life sciences or STEM disciplines and a minimum of 18 years of related experience; or, MS/M.Sc. preferably in the life sciences or STEM disciplines and a minimum of 16 years of related experience; or, PhD preferably in the life sciences or STEM disciplines, and a minimum of 15 years of related experience; or, Equivalent combination of education and experience. Knowledge, Skills and Abilities: Experience/The Ideal for Successful Entry into Job: Typically requires a minimum of 22 years' experience in the biotech, pharmaceutical, or related industry Typically requires a minimum of 10 years of people management at various levels of the management (direct or indirect). Demonstrated knowledge of GCP, GVP, and Quality Systems. Requires a broad range of knowledge and experience with clinical trial conduct and international regulations. Experienced in hosting regulatory inspections, presenting or defending functions in internal audits or audits by business partners, clinical site audits, and regulatory inspections. International/global experience preferred. Experience in auditing is preferred. Proven leadership, organizational, and management skills to coordinate multi-disciplinary groups, ability to manage complex issues, sound decision-making, and strategic planning skills, develops company objectives and principles, and achieves goals with measurable impact and outcomes. Qualified QA professional, with a broad range of knowledge and experience with global clinical trials and related GCP/GVP processes, as well as global QA and regulatory compliance.GCP/GVP. Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results. Ensures successful completion of major programs, projects, and/or functions. Has a solid understanding of peer company best practices with respect to clinical trial execution and is able to review existing processes and refine or improve them over time. Knowledge/Skills: Deep knowledge and understanding of GCP and GVP in the context of clinical trials drug development process and GxP Global Regulatory Requirements. Uses broad expertise or unique knowledge and skills to deliver on company goals and priorities with measurable impact and outcomes. Ability to influence decision makers, utilizing sound problem-solving skills to recommend and implement feasible solutions. Skilled leader of inspection readiness GCP/GVP working groups. Excellent written, oral, and presentation communication skills, able to translate complex concepts across all levels of the organization. Applies analytical thinking to develop technical and/or business solutions to complex problems. Applies strong analytical thinking to develop technical and/or business solutions to complex problems. Drives for results. Hires strong talent and engages the team by providing training and guidance to drive for measurable results. Proven leader with demonstrated ability to build and lead successful teams. Strong collaboration skills, demonstrated ability to lead through change, and identify opportunities that result in positive business outcomes. Excellent organizational agility and project management skills; gets results while strengthening internal and external relationships. Consistent demonstration of making timely decisions without complete data to ensure quality product to patients; sound quality judgement and balance between business, supply, and quality. Highly skilled in working with ambiguity and complexity; continuously modifies options and solutions across all levels of the organization. Travel to key sites as required. JOB COMPLEXITY: This role requires a skillset that includes the ability to lead change by engaging others, assessing unforeseen situations, and continuously learning to achieve a goal. This role is critical to the success of the company's core deliverables and requires continuous communication to maintain alignment across the organization. This role requires management of multiple competing priorities, and the ability to evaluate data to detect weak signals, blind spots, and escalate cumulative risks. Work Environment/Physical Demands: Our office is a modern, open-planned space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace. Travel as required (20-30%) This position is onsite at our Alameda, CA headquarters #LI-HG1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $248,000 - $353,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

SUMMARY/JOB PURPOSE: The Senior Staff IT Product Lead - Digital Applications, will lead a portfolio of digital products critical to Exelixis's success and ambition to launch innovative medicines for patients. This role is pivotal in driving the strategy, development, and operational excellence of our digital application ecosystem, ensuring alignment with business objectives and a strong focus on user experience and value delivery. Operating within a product-centric model, the Senior Staff IT Product Lead will be responsible for defining product roadmaps, fostering cross-functional collaboration, and leading agile product teams to deliver innovative and impactful digital solutions that accelerate drug discovery, development, and commercialization. ESSENTIAL DUTIES AND RESPONSIBILITIES: Product Strategy & Roadmap (Product-Centric Focus): • Own two or more digital products coupled with a thorough understanding and execution of the vision and strategy for those digital products within the Digital Applications job family (e.g., Clinical Trials Applications, R&D Informatics, and Supply Chain)., • Own two or more digital products and work with business owners and stakeholders to gather user needs and drive the development of product requirements and user stories., • Support other leads in market research and technology reviews to support product planning and identify potential areas for improvement., • Own and support the evaluation of product initiatives by helping assess business value, technical feasibility, and compliance considerations., • Own the architecture and design of one or two products and ensure digital solutions are aligned with enterprise design and security standards. Product Development & Delivery (Agile/Product Team Support): • Own product development activities across one or more digital products through the lifecycle-from concept to launch and post-launch support-using Agile practices (e.g., Scrum, Kanban)., • Own the drafting of user stories and acceptance criteria across two or more digital products., • Own the collaboration with engineering, architecture, and QA teams to support the delivery of secure, scalable, and high-quality digital applications., • Own the coordination with vendors and service providers to support product delivery timelines and operational needs across two or more digital products., • Own the user experience improvements across one or more Digital products by incorporating feedback from usability testing and end user research. Stakeholder Management & Cross-Functional Collaboration: • Support communication between IT and business teams by helping translate technical concepts into business-friendly language across two or more functional areas., • Build working relationships with stakeholders to support alignment on product goals and deliverables across two or more functional areas., • Actively contribute in team meetings and cross-functional discussions to stay aligned on priorities and progress., • Own the planning sessions and provide input on product-related decisions as appropriate to two or more digital products. Operational Excellence, Quality & Compliance: • Ownership in maintaining the stability, performance, and security of digital applications in collaboration with IT operations and infrastructure teams., • Ownership in managing vendor interactions and support the use of third-party software solutions., • Ownership in supporting compliance efforts by helping ensure product features and processes meet regulatory and internal standards (e.g., GxP, HIPAA, GDPR)., • Ownership to quality assurance activities to help ensure product deliverables meet expectations to two or more digital products., • Ownership in the Implementation and maintenance of robust data management & AI practices to protect sensitive information and ensure its accuracy and reliability to two or more digital products., • Ownership in monitoring product performance metrics and KPIs to support continuous improvement efforts to two or more digital products. SUPERVISORY RESPONSIBILITIES: • No supervisory responsibilities. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: • Bachelor's degree in related discipline and 9 years of related experience; or, • Master's degree in mathematics or statistics or engineering and 7 years of related experience., • PhD degree in a related discipline and 5 years of related experience; or, • Equivalent combination of education and experience. Experience/The Ideal Candidate will have: • Minimum of 5 years of experience supporting Enterprise IT enabling business functions., • Minimum of 7+ years of progressive experience in IT, focused on digital applications or product management within the life science or pharmaceutical industry., • Proven experience in leading product development teams in an agile/product-centric operating model is essential., • Strong understanding of the drug discovery, clinical development, quality and regulatory submissions lifecycle within a pharmaceutical or biotechnology company., • Demonstrated success in defining and delivering complex digital products that drive significant business value., • Experience with one of the mentioned specific technologies or platforms as relevant to the specific role, [e.g., applications/platforms (Veeva, LabWare LIMS, Tracelink, etc.) or cloud solutions (AWS, Azure), or functional capabilities specific to business function such as LIMS, EDC, CTMS, CRM systems widely used in pharma]., • Experience with regulatory frameworks and compliance in a GxP environment. Knowledge / Skills: • Exceptional leadership and team-building skills, with the ability to inspire and motivate diverse teams., • Strong strategic thinking and problem-solving abilities, with a data-driven approach to decision-making., • Excellent communication, presentation, and interpersonal skills, with the ability to influence and collaborate effectively at all levels of the organization., • Deep understanding of product management methodologies (e.g., Agile, Scrum, Kanban) and product lifecycle management., • Solid technical acumen with the ability to understand complex IT architectures and development processes., • Ability to manage multiple priorities in a fast-paced, dynamic environment. Occasional travel may be required to other company sites, conferences, or vendor locations. WORKING CONDITIONS: • Our office is a modern, open-plan space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace., • Occasional travel (5-10%) may be required to other company sites, conferences, or vendor locations., • On-call availability for critical escalations. #LI-EZ1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $168,500 - $239,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

SUMMARY/JOB PURPOSE: Provides leadership within biostatistics function to develop and execute statistical strategy, design and analyses for clinical trials in all phases. Applies sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements. Develops and/or applies statistical theories, methods and software. Partners in clinical development program, study design, establishing standards for clinical conduct, and the collection, management and/or reporting of data. Develops and implements biostatistics department policies, standards, practices and work-instructions in coordination with department leader and leaders in other functions. Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success. Represents biostatistics function in interactions with institutional review boards, ethics committees, and health agencies. Manages timelines, deliverables and budgets of contract research organizations. Essential Duties And Responsibilities: • Work with department head to develop and implement department standards and practices., • Direct the statistical design, conduct, and analysis of clinical trials in all phases., • Review protocols and case report forms for soundness of trial design., • Review and or author statistical analysis plans for all phases of a trial., • Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications., • Direct the development, validation and summary of integrated safety and efficacy summaries., • Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements., • Attend meetings with FDA or EU Authority to ensure ongoing agreement on project development., • Contribute to the development of Requests-for-Proposals., • Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets., • Responsible for all statistical oversight within a therapeutic area. Supervisory Responsibilities: • No supervisory responsibilities. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: • BS/BA degree in Statistics/Biostatistics or related discipline and a minimum of thirteen years of related experience; or,, • MS/MA degree in Statistics/Biostatistics or related discipline and a minimum of eleven years of related experience; or,, • PhD in Statistics/Biostatistics or related discipline and a minimum of eight years of related experience, or;, • Equivalent combination of education and experience., • May require certification in assigned area. Experience/The Ideal for Successful Entry into Job: • Managed and or supported clinical trials, preferably in the therapeutic area of oncology and in the biotech/pharmaceutical industry., • Preferably led a phase III clinical trial., • In-depth knowledge of CDISC standards., • Management and statistical analysis of data obtained from Phase I - IV clinical studies in support of US NDAs., • Direct experience with FDA/EU Authority preferred., • Typically requires a minimum of 15 years of related experience and/or combination of experience and education/training. Knowledge/Skills: • Comprehensive and detailed knowledge of: statistical experimental designs, analyses and clinical trial requirements, particularly pertaining to oncology trials., • Developed/reviewed SDTM/ADaM specifications., • Excellent knowledge of FDA/EU statistical guidelines., • Management and statistical analysis of data obtained from Phase I - IV studies in support of NDAs., • Must have experience in state-of-the-art data organization and statistical analyses using statistical software such as: SAS, EAST, nQuery, Cytel Studio., • Guides the successful completion of major programs, projects and/or functions by identifying and implementing appropriate techniques and evaluation criteria., • Has understanding of other disciplines such as data management, clinical operation, clinical science, regulatory affairs and drug safety., • Project management and contract negotiation with outside vendors., • Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve these goals in creative and effective ways., • Develops technical and/or business solutions to complex problems., • Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company., • Applies strong analytical and business communication skills. JOB COMPLEXITY: • Works on significant and unique issues where analysis scenarios require an evaluation of intangibles., • Works on complex issues where analysis scenarios require an in-depth knowledge of the company., • Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results., • Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people., • Ensures budgets and schedules meet corporate requirements., • Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers. #LI-JP1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $188,000 - $266,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

SUMMARY/JOB PURPOSE: Leads the biostatistics function in developing statistical strategy, design, and analyses for conducting clinical trials in all phases for multiple compounds. Understands at a deep level clinical trials principles and norms. Applies sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements. Develops and/or applies statistical theories, methods, and software. Partners in clinical development program, study design, establishing standards for clinical conduct, and the collection, management and/or reporting of data. Recruits, develops, and supervises project statisticians. Develops and implements biostatistics department policies, standards, practices, and work-instructions in coordination with senior department leader and leaders in other functions. Leads initiatives for process improvement and or standardizations for biostatistics activities and deliverables. Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success. Manages timelines, deliverables, and budgets of contract research organizations. Essential Duties And Responsibilities: • Provide vision and direction for the development and implementation of department standards and practices., • Provide oversite of standardization and/or process improvement initiatives, • Provide strategic input on Exelixis clinical development programs, • Provide technical oversight of the statistical design, conduct, and analysis of clinical trials in all phases., • Review protocols and case report forms for soundness of trial design., • Review statistical analysis plans for all phases of a trial., • Direct analysis, interpret study results, and collaborate with study team to deliver interim reports, final reports, safety updates and publications., • Guide the successful completion of major programs, projects and/or functions by identifying and implementing appropriate techniques and evaluation criteria., • Lead or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing., • Management and statistical analysis of data obtained from Phase I - IV clinical studies in support of NDAs., • Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements., • Attend meetings with FDA or EU Authority to ensure ongoing agreement on project development., • Contribute to the development of Requests-for-Proposals for evaluation of Contract Research Organizations for biostatistics, programming, and data management activities., • Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables, and budgets., • Responsible for all statistical oversight within the biostatistics function., • Interpret, execute, and recommend modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company., • Build strong relationships both within and outside biostatistics Supervisory Responsibilities: • Supervise biostatisticians., • Indirectly supervise employees in other functions through a dotted line structure or via other subordinate supervisors. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: • MS/MA degree in Statistics/Biostatistics or related discipline and a minimum of 16 years of related experience; or,, • PhD in Statistics/Biostatistics or related discipline and a minimum of 15 years of related experience; or,, • Equivalent combination of education and relevant experience in oncology., • May require certification in assigned area. Experience/The Ideal for Successful Entry into Job: • Managed clinical trials in the therapeutic area of oncology for at least 5+ years and other therapeutic areas for 10+ years., • Supervision of multiple statisticians required., • Has led phase 1-4 (preferably phase 3) oncology studies., • Knowledgeable regarding FDA/EMA/ICH guidelines for drug development, new methodology in statistics and statistical/clinical data analyses., • In-depth knowledge of CDISC standards., • Ability to work simultaneously on multiple projects and multiple compounds, and to deliver high-quality work according to tight timelines., • Direct experience with FDA/EU Authority preferred. Knowledge/Skills: • Strong people management and interpersonal skills, • Strong communication skills, • Strong conflict management skills, • Comprehensive and detailed knowledge of statistical experimental designs, analyses, and clinical trial requirements, particularly pertaining to oncology trials., • Developed/reviewed SDTM/ADaM specifications., • Excellent knowledge of FDA/EU/ICH statistical guidelines., • Must have experience in state-of-the-art data organization and statistical analyses using statistical software such as SAS, EAST, nQuery, Cytel Studio., • Has understanding of other disciplines such as data management, clinical operation, clinical science, regulatory affairs, and drug safety., • Project management and contract negotiation with outside vendors., • Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve these goals in creative and effective ways., • Develops technical and/or business solutions to complex problems., • Applies strong analytical and business communication skills. JOB COMPLEXITY: • Works on significant and unique issues where analysis scenarios require an evaluation of intangibles., • Works on complex issues where analysis scenarios require an in-depth knowledge of the company., • Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results., • Participates in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people., • Ensures budgets and schedules meet corporate requirements., • Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers. #LI-JP1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $271,000 - $385,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Summary/Job Purpose (Basic purpose of the job): The Senior DMPK Director has strong scientific, technical and leadership skills to develop and implement DMPK and modeling & simulation strategies to advance drug candidates from discovery to development stage and build comprehensive DMPK packages to enable successful drug registration. The senior director is responsible for providing strategic and technical subject matter expertise as well as scientific accountability and oversight for the DMPK support of several programs in Exelixis' portfolio. The Senior Director contributes to growth of the Clinical Pharmacology and Pharmacometrics department and may mentor junior scientists. Essential Duties/Responsibilities: • Lead the Translational IND- and NDA-enabling ADME work; characterize the ADME properties of molecules and collaborate to establish in vitro to in vivo correlations; ensure that all DMPK studies and analyses are consistent with regulatory guidance, • Analyze and interpret preclinical pharmacokinetic and pharmacodynamic data to inform drug development decisions, • Closely partner with Discovery to evolve translational ADME strategies and collaborate on roll-out, education and execution to ensure deep integration of knowledge from Discovery to Development, • Closely partner with Clinical Pharmacology and pharmacometrics to ensure a seamless transition of molecules to development and generate the preclinical data needed to inform the Clinical Pharmacology development plans, • Work collaboratively with other functional partners including Translational Medicine, CMC, Toxicology, Clinical Development and Regulatory to deliver on project and corporate objectives, • Prepare high quality regulatory documents including IND, CTA, and NDA filings; prepare DMPK components of nonclinical and clinical study protocols, nonclinical and clinical study reports, and investigator brochures, • Support functional area reviews for due diligence evaluations, • Conduct scientific presentations to senior management, project teams, and internal/external collaborators, • Stay up-to-date with advancements in DMPK research and identify and integrate emerging science to advance the portfolio, • Maintain external scientific visibility through publications, • Foster a science-driven, goal-oriented culture that values innovation, teamwork, agility, transparency, accountability, and empowerment, • Comply with company health and safety policies and general laboratory practices. SUPERVISORY RESPONSIBILITIES: • No supervisory responsibilities. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: • PhD degree in Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, or other relevant field and a minimum of 12 years of relevant experience in DMPK in the pharmaceutical industry Experience: • Minimum 12 years experience in DMPK, • Expert knowledge of in vitro and in vivo ADME studies, • Strong experience of managing external DMPK work at CROs, • Extensive experience in identifying clinical candidates through balancing ADME, pharmacology and toxicology properties and progressing molecules into clinical trials, • Solid experience in utilization of physiologically-based and empirical modeling and simulations techniques to characterize drug-drug interactions and biopharmaceutics liabilities, • Experience with submission of IND/NDA/BLA and global marketing applications, • Experience with antibody drug conjugates is a plus Knowledge, Skills and Abilities: • Extensive scientific and technical knowledge around drug metabolism and drug transporters, including enzymology and enzyme kinetics and in vitro to in vivo extrapolation, • Demonstration of independent thought/creativity in science and drug discovery, • Experience in applying emerging science and technologies to strengthen and improve research capabilities, • In-depth knowledge of current practices and issues in DMPK (including regulatory requirements), PKPD and translational sciences, • Keen desire to grow and develop the careers of team members, • Demonstrates strong leadership; and has the ability to influence and make decisions, • Excellent collaborative verbal and written communication skills, • Able to work well with multi-disciplinary teams, • Works on problems of diverse scope where analysis and review of data requires evaluation of identifiable factors. Works on ADME complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, • Exercises independent judgment in selecting methods, techniques, and evaluation criteria for obtaining results, • Networks with key contacts outside own area of expertise, • Thrives in a fast-paced business environment, • Function in a highly matrixed team environment, • Establish collaborative networks between functional areas, • Find creative solutions to unique and complex problems, • Manage within performance teams Work Environment/Physical Demands: Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic workstations, to ensure a comfortable workspace. Travel requirements can be listed by stating up to certain % of time traveling. #LI-JP1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $183,000 - $260,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

SUMMARY/JOB PURPOSE: The Senior Clinical Trials Manager, Clinical Operations, combines end-to-end design, execution, and reporting of oncology clinical trials with leadership in study teams and across matrix teams. This position within Clinical Operations is accountable for planning and leading the delivery of studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study protocol. This involves generating robust and accelerated delivery plans (with a focus on performance) and delivering these to target or stretch thresholds. The Senior Clinical Trials Manager, Clinical Operations, is the Study Delivery Lead (SDL). The SDL is the study accountable person, and the studies may span oncology products from early through to late phase of development and include delivery through one or more of in-house, outsourced and alliance delivery models. The SDL is the Clinical Operations leader of the Study Delivery Team (SDT). ESSENTIAL DUTIES AND RESPONSIBILITIES: • Accountable for the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc.) and for overall study deliverables., • Drive assessment, selection, engagement, management, and oversight of appropriate vendors., • Ensure compliance with ICH/GCP guidelines, all applicable laws, and regulations, and Exelixis SOPs, for all products and services delivered for their designated studies., • Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate., • Work with matrix partners, Clinical Operations Program Lead and/or manager to develop and manage study level budget within project allocation., • Prepare materials for internal governance and / or financial review cycles., • ctively partner to build relationships and collaborate with aligned staff in other functions., • Encourage others within matrix and line teams to seek alternative perspectives and develop solutions., • Lead and conduct investigator meetings and other study related meetings and participate in governance meetings, as necessary., • Identify and communicate resource gaps for assigned studies., • Lead risk management and quality efforts to ensure study compliance and continual inspection readiness., • Lead / contribute to ways of working and process improvement initiatives., • Provide expert clinical operational input into protocol development., • Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study., • As the SDL, lead the SDT and actively partner to build relationships and collaborate with SDT functional members., • Work with the appropriate functions to develop patient centric documents and address patient burden., • Contribute to and engages Clinical Operations staff in process development, innovative problem solving, training initiatives as needed., • Provide proactive and consistent oversight of CRO and vendor performance., • Support Clinical Operations Program and / or Indication Lead with key study level status updates, with a particular focus on delivery to corporate and project level objectives. SUPERVISORY RESPONSIBILITIES: • None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: • BA/BS in biological sciences or related field and a minimum of 9 years of related experience; or,, • MA/MS in biological sciences or related field and a minimum of 7 years of related experience; or,, • PhD/PharmD in biological sciences or related field and a minimum of 2 years of related experience; or,, • Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: • Typically requires a minimum of 9 years of related experience in life sciences, including 7 years of experience in clinical research and at least 4 years of study management Knowledge/Skills: • Experience in either starting a study up, working on the maintenance phase, or close-out of study, • Protocol development experience, • Proven ability to provide clinical expertise to a clinical development program., • Proficiency in clinical studies involving complex design., • Experience in independent preparation of clinical sections of IND, BLA, or NDA, • Demonstrated ability to write and present clearly using on scientific and clinical issues terminology, • Experience with management of multinational clinical trials, • Experience in interactions with outside vendors, e.g., CROs and contract labs, • Demonstrated matrix leadership skills, • Detailed knowledge of regulations and guidelines, • Excellent organizational and planning skills, • Demonstrated ability to write and present clearly using on scientific and clinical issues terminology, • Strong interpersonal skills and communication skills (both written and oral), • Ability to work effectively in a team/matrix environment, • Applies strong analytical and business communication skills JOB COMPLEXITY: • Capable of anticipating, identifying, prioritizing and resolving task-related challenges, • Ability to write and present clearly especially on scientific and clinical issues, • Ability to work effectively in a team/matrix environment, • Excellent interpersonal, organizational, supervisory and project planning skills., • Demonstrated professional collaboration skills DESIRED BEHAVIORS: • Approaches problems and solutions with an enterprise mindset, considering broad impact to portfolio, regional and global functions, • Ability to study, analyze and understand new situations and business problems and identify appropriate solutions, • Curious in planning; agile in execution, • Operationally excellent and drives others towards excellence, • Resilient in the context of a rapidly changing environment, • Organized with a systematic approach to prioritization EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS: • We drive for results, so patients can survive and thrive., • We are resilient in the face of adversity, and tireless in advancing our science., • We celebrate our long history of prolific drug discovery and rigorous drug development., • We unite to launch innovative medicines for difficult-to-treat cancers., • We exist to give people hope - one drug, one patient at a time., • We are Exelixis. LIVES THE EXELIXIS CORE VALUES DAILY: • Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way),, • Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results), • Excel for Patients (Innovate to design solutions and remove barriers to show how much we care) WORKING CONDITIONS: • Travel may be required up to 20% in support of clinical study activities #LI-JD1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $172,000 - $245,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

SUMMARY/JOB PURPOSE: In collaboration with the Exelixis clinical teams, the primary role is to lead and execute clinical trials for oncology products in development. Participates in the design/planning of clinical studies and helps with the interpretation of study results. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators for research studies. Responsibilities also include adverse event reporting and safety responsibilities monitoring. Monitors adherence to protocols and determines study completion. Essential Duties And Responsibilities: • Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice., • Act as medical monitor for company sponsored trials., • Support project teams with therapeutic area specific information., • Collaborate with internal safety group in analyzing and reporting of safety data from clinical trials., • Analyze and interpret other clinical trial data and prepare reports for regulatory agencies and publication., • Interact with key opinion leaders and investigators in relevant disease specific area., • Ensure consistency of scientific and development strategies for oncology products in development., • Maintain the highest level of scientific and clinical knowledge in relevant disease specific area. Supervisory Responsibilities: • None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: • MD (board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential) required with a minimum of 5 years of post-residency experience., • Equivalent combination of education and experience Experience/The Ideal for Successful Entry into Job: • Drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry. Note: Individuals with extensive academic experience but without experience in the pharmaceutical industry may be considered, • Hands-on experience in the design, execution, and reporting of controlled clinical trials in oncology., • Participated in clinical oncology studies with molecular targeted or immunological therapies., • Understanding of basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics). Knowledge/Skills: • Proven ability to effectively work in a cross-functional/matrix environment, • Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways., • Develops technical and/or business solutions to complex problems., • Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results., • Ability to develop and maintain relationships with significant key opinion leaders., • Strong interpersonal, influencing, presentation, and written and verbal communication skills, • Strong organizational and time management skills JOB COMPLEXITY: • Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors, • Works on abstract problems across functional areas of the business, • Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results., • Regularly interacts with executives and/or major customers. #LI-JD1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $254,500 - $361,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

SUMMARY/JOB PURPOSE: The Senior Clinical Trials Manager, Clinical Operations, combines end-to-end design, execution, and reporting of clinical trials with leadership in study teams and across matrix teams. This position within Clinical Operations is accountable for planning and leading the delivery of studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study protocol. This involves generating robust and accelerated delivery plans (with a focus on performance) and delivering these to target or stretch thresholds. The Senior Clinical Trials Manager, Clinical Operations, is the Study Delivery Lead (SDL). The SDL is the study accountable person, and the studies may span oncology products from early through to late phase of development and include delivery through one or more of in-house, outsourced and alliance delivery models. The SDL is the Clinical Operations leader of the Study Delivery Team (SDT). * Located onsite in Alameda, CA ESSENTIAL DUTIES AND RESPONSIBILITIES: • Accountable for the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc.) and for overall study deliverables., • Drive assessment, selection, engagement, management, and oversight of appropriate vendors., • Ensure compliance with ICH/GCP guidelines, all applicable laws, and regulations, and Exelixis SOPs, for all products and services delivered for their designated studies., • Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate., • Work with matrix partners, Clinical Operations Program Lead and/or manager to develop and manage study level budget within project allocation., • Prepare materials for internal governance and / or financial review cycles., • ctively partner to build relationships and collaborate with aligned staff in other functions., • Encourage others within matrix and line teams to seek alternative perspectives and develop solutions., • Lead and conduct investigator meetings and other study related meetings and participate in governance meetings, as necessary., • Identify and communicate resource gaps for assigned studies., • Lead risk management and quality efforts to ensure study compliance and continual inspection readiness., • Lead / contribute to ways of working and process improvement initiatives., • Provide expert clinical operational input into protocol development., • Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study., • As the SDL, lead the SDT and actively partner to build relationships and collaborate with SDT functional members., • Work with the appropriate functions to develop patient centric documents and address patient burden., • Contribute to and engages Clinical Operations staff in process development, innovative problem solving, training initiatives as needed., • Provide proactive and consistent oversight of CRO and vendor performance., • Support Clinical Operations Program and / or Indication Lead with key study level status updates, with a particular focus on delivery to corporate and project level objectives. SUPERVISORY RESPONSIBILITIES: • None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: • BA/BS in biological sciences or related field and a minimum of 9 years of related experience; or,, • MA/MS in biological sciences or related field and a minimum of 7 years of related experience; or,, • PhD/PharmD in biological sciences or related field and a minimum of 2 years of related experience; or,, • Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: • Typically requires a minimum of 9 years of related experience in life sciences, including 7 years of experience in clinical research and at least 4 years of study management Knowledge/Skills: • Experience in either starting a study up, working on the maintenance phase, or close-out of study, • Protocol development experience, • Proven ability to provide clinical expertise to a clinical development program., • Proficiency in clinical studies involving complex design., • Experience in independent preparation of clinical sections of IND, BLA, or NDA, • Demonstrated ability to write and present clearly using on scientific and clinical issues terminology, • Experience with management of multinational clinical trials, • Experience in interactions with outside vendors, e.g., CROs and contract labs, • Demonstrated matrix leadership skills, • Detailed knowledge of regulations and guidelines, • Excellent organizational and planning skills, • Demonstrated ability to write and present clearly using on scientific and clinical issues terminology, • Strong interpersonal skills and communication skills (both written and oral), • Ability to work effectively in a team/matrix environment, • Applies strong analytical and business communication skills JOB COMPLEXITY: • Capable of anticipating, identifying, prioritizing and resolving task-related challenges, • Ability to write and present clearly especially on scientific and clinical issues, • Ability to work effectively in a team/matrix environment, • Excellent interpersonal, organizational, supervisory and project planning skills., • Demonstrated professional collaboration skills DESIRED BEHAVIORS: • Approaches problems and solutions with an enterprise mindset, considering broad impact to portfolio, regional and global functions, • Ability to study, analyze and understand new situations and business problems and identify appropriate solutions, • Curious in planning; agile in execution, • Operationally excellent and drives others towards excellence, • Resilient in the context of a rapidly changing environment, • Organized with a systematic approach to prioritization EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS: • We drive for results, so patients can survive and thrive., • We are resilient in the face of adversity, and tireless in advancing our science., • We celebrate our long history of prolific drug discovery and rigorous drug development., • We unite to launch innovative medicines for difficult-to-treat cancers., • We exist to give people hope - one drug, one patient at a time., • We are Exelixis. LIVES THE EXELIXIS CORE VALUES DAILY: • Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way),, • Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results), • Excel for Patients (Innovate to design solutions and remove barriers to show how much we care) WORKING CONDITIONS: • Travel may be required up to 20% in support of clinical study activities DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class. If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $172,000 - $245,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

SUMMARY/JOB PURPOSE: The Clinical Supplies Manager II oversees all aspects of clinical supply management including packaging, labeling, monitor inventory levels, and distribution by interacting with internal and external supply partners/vendors to ensure supply of IMP are sufficient at depots and clinical sites. Essential Duties And Responsibilities: • Lead effort for clinical supply management functionality., • Monitor and manage clinical supply activities through IRT from study start-up through study closure., • Proactively drive the labeling, packaging, release, distribution of clinical supplies at external CMO's for assigned studies, ensuring the project timeline is met or exceeded., • Ensure domestic and global distribution arrangements are in place with external vendors to allow shipment following availability of technical and regulatory releases., • In collaboration with relevant partners, create forecasts and packaging design based on study needs to ensure optimized supply plan., • Partner with key stakeholders (including Quality Assurance and Regulatory Affairs) to ensure supplies are labelled and released for clinical site shipment for global clinical trials., • Work cross-functionally to develop IRT to develop specifications and perform UAT., • Design and/or review label text to meet product requirements and ensure compliance with US and international regulations., • Represent clinical supplies function at clinical trial team meetings; communicate plan and timelines to internal and external customers and partners., • Work with cross-functional teams to develop specifications and user testing of IRT systems provided by 3rd party vendors., • Ensure appropriate system documentation is transferred to TMF and ready for inspection readiness., • Utilize appropriate software and IT systems to effectively manage key project activities. Supervisory Responsibilities: • None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: • BS/BA degree in related discipline and a minimum of seven years of related experience; or,, • MS/MA degree in related discipline and a minimum of five years of related experience; or,, • Equivalent combination of education and experience., • Certification in assigned areas is a plus. Experience/The Ideal for Successful Entry into Job: • Demonstrated experience with clinical supply management planning, labeling, packaging, and distribution., • Clinical Supply management experience using contract manufacturing companies strongly preferred., • Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS Knowledge/Skills: • Willingness to work in a fast paced, evolving environment., • Knowledge of GMP batch record development, review, and approval processes., • Knowledge of Interactive Voice/Web response systems for use in clinical studies., • Working knowledge of regulations relating to clinical labeling, packaging and distribution activities., • Working knowledge of GMP/GCP/GLP regulations required., • Excellent project management and communication skills. JOB COMPLEXITY: • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors., • Uses professional concepts and company objectives to resolve moderate to complex issues in creative and effective ways., • May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors., • Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results., • Networks with key contacts outside own area of expertise. Working Conditions: • 20% travel to vendor sites, team meetings, and/or other offices. Work Environment/Physical Demands: Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace. #LI-MB1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $132,500 - $188,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

SUMMARY/JOB PURPOSE: This key role drives consistency across QA systems and processes for the Clinical QA team, identifying issues and risks, escalating in a timely fashion, and aligning metrics that provide input into a compliance scorecard for Clinical programs. This leader provides insight and partners with both GCP QA staff and Clinical Operations Quality Management (OQM) to address day-to-day clinical trial operations activities focused on deviations, investigations, audit findings and CAPAs. This role operates across all the Clinical project teams and provides training with inspection readiness activities as required. Essential Duties And Responsibilities: Responsible for designing and coordinating a comprehensive view and aligning standards on Quality systems across Clinical Quality Assurance. Assesses current state, identifies gaps, develops an action plan, implements improvements, and monitors the Quality Systems and internal processes related to GCP QA activities Develops, tracks, and manages periodic management reports focused on track and trend data for key Clinical and QA metrics driving the quality health of the GCP activities. Reviews and approves Deviations, and Corrective and Preventive Actions (CAPAs) Partners with other groups including Regulatory Affairs, Clinical Operations, Translational Medicine, regarding compliance issues and provides compliance guidance Maintains knowledge of current Health Authority regulations and standards and informs Clinical Development stakeholders of potential impact on the organization Represents CQA in internal presentations on quality issues, initiatives, and projects Identifies issues and risks and proposes options and solutions, escalating risks in a timely manner. Participates in identifying and implementing process and system improvements Supervisory Responsibilities: None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 11 years of relevant experience; or, Master's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of relevant experience; or, PhD degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 5 years of relevant experience; or, Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: Minimum of 10 years relevant experience in pharmaceutical and biotech industries. Experience in Good Clinical Practices highly desired Demonstrated experience in Quality Systems including critical analysis of impact and continuous improvement processes Strong understanding of Quality Risk Management Experience using standard MS Office Knowledge/Skills: Understanding of the drug development process, particularly related to QA oversight of clinical trials Experience in assisting in the development of business strategies, metrics, and continuous improvements Working knowledge of Health Authority rules and regulations Proven ability to manage Quality Systems, assuring completeness and acceptability as defined for GCP. Ability to apply Quality Risk Management in a variety of situations across Quality Systems Ability to influence others as part of a collaborative team and negotiate effective solutions Strong interpersonal and social skills Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results. Detail-oriented in execution of tasks and processes Implements technical solutions within quality requirements to complex problems. Excellent verbal and written communication skills Exercises judgment within defined procedures and practices to determine appropriate action. Provides insight and analysis of situations or data requires a review of a variety of factors. Working Conditions: Environment: primarily working in laboratories or in office Infrequent travel may be required. #LI-HG1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $177,500 - $251,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

SUMMARY/JOB PURPOSE: Applies extensive technical expertise and experience to provide written and verbal recommendations on statistical issues, design and conduct of clinical trials of all phases. Uses initiative to develop, maintain and share knowledge of the theory and application of current statistical methods appropriate for data analysis and clinical trial design. Works collaboratively with clinicians, data managers, biostatisticians, statistical programmers, and medical writers in the planning, conduct and analysis of clinical trials. Essential Duties And Responsibilities: • Work with project team members on developing clinical protocol. Review CRFs, CRF edit checks and CRF completion guidelines. Author statistical analysis plan, TLF shells and Table of contents for outputs to be generated. Review ADaM specifications and verify primary and secondary efficacy endpoints., • Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications., • Effectively manage CRO to ensure high-quality deliverables within timeline and budget., • Oversee programming of ADaMs and TLFs for the study., • Responsible for one or more studies with concurrent tasks and timelines., • Participate in the validation/QC of key study endpoint analysis and submission deliverables., • Apply appropriate regulatory guidelines to the projects. Supervisory Responsibilities: • None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: • MS/MA degree in related discipline and a minimum of 9 years of related experience; or,, • PhD in related discipline and a minimum of 5 years of related experience; or,, • Equivalent combination of education and experience., • May require certification in assigned area. Experience/The Ideal for Successful Entry into Job: • Experience in oncology and study Phases I-III highly preferred., • Experience in Biotech/Pharmaceutical industry preferred., • Experience with managing CROs in the conduct of clinical trials., • Experience with statistical applications and clinical data management procedures in the conduct of clinical trials., • Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings. Knowledge/Skills: • Knowledge of appropriate regulations, industry standards and guidance documents., • Ability to interact effectively with biostatistical, data management, operations, and clinical personnel from CROs and companies collaborating with Exelixis., • Developed/reviewed SDTM/ADaM specifications, • Strong SAS programming knowledge., • Guides the successful completion of major programs, projects and/or functions., • Leads or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing., • Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways., • Develops technical and/or business solutions to complex problems., • Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results., • Performs a variety of complicated tasks with a wide degree of creativity and latitude., • Has complete understanding and wide application of technical principles, theories, concepts, and techniques., • Has good general knowledge of other related disciplines., • Applies strong analytical and business communication skills. #LI-JP1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $166,500 - $236,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

SUMMARY/JOB PURPOSE: The Senior Clinical Trials Manager, Clinical Operations, combines end-to-end design, execution, and reporting of clinical trials with leadership in study teams and across matrix teams. This position within Clinical Operations is accountable for planning and leading the delivery of studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study protocol. This involves generating robust and accelerated delivery plans (with a focus on performance) and delivering these to target or stretch thresholds. The Senior Clinical Trials Manager, Clinical Operations, is the Study Delivery Lead (SDL). The SDL is the study accountable person, and the studies may span oncology products from early through to late phase of development and include delivery through one or more of in-house, outsourced and alliance delivery models. The SDL is the Clinical Operations leader of the Study Delivery Team (SDT). ESSENTIAL DUTIES AND RESPONSIBILITIES: • Accountable for the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc.) and for overall study deliverables., • Drive assessment, selection, engagement, management, and oversight of appropriate vendors., • Ensure compliance with ICH/GCP guidelines, all applicable laws, and regulations, and Exelixis SOPs, for all products and services delivered for their designated studies., • Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate., • Work with matrix partners, Clinical Operations Program Lead and/or manager to develop and manage study level budget within project allocation., • Prepare materials for internal governance and / or financial review cycles., • ctively partner to build relationships and collaborate with aligned staff in other functions., • Encourage others within matrix and line teams to seek alternative perspectives and develop solutions., • Lead and conduct investigator meetings and other study related meetings and participate in governance meetings, as necessary., • Identify and communicate resource gaps for assigned studies., • Lead risk management and quality efforts to ensure study compliance and continual inspection readiness., • Lead / contribute to ways of working and process improvement initiatives., • Provide expert clinical operational input into protocol development., • Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study., • As the SDL, lead the SDT and actively partner to build relationships and collaborate with SDT functional members., • Work with the appropriate functions to develop patient centric documents and address patient burden., • Contribute to and engages Clinical Operations staff in process development, innovative problem solving, training initiatives as needed., • Provide proactive and consistent oversight of CRO and vendor performance., • Support Clinical Operations Program and / or Indication Lead with key study level status updates, with a particular focus on delivery to corporate and project level objectives. SUPERVISORY RESPONSIBILITIES: • None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: • BA/BS in biological sciences or related field and a minimum of 9 years of related experience; or,, • MA/MS in biological sciences or related field and a minimum of 7 years of related experience; or,, • PhD/PharmD in biological sciences or related field and a minimum of 2 years of related experience; or,, • Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: • Typically requires a minimum of 9 years of related experience in life sciences, including 7 years of experience in clinical research and at least 4 years of study management Knowledge/Skills: • Experience in either starting a study up, working on the maintenance phase, or close-out of study, • Protocol development experience, • Proven ability to provide clinical expertise to a clinical development program., • Proficiency in clinical studies involving complex design., • Experience in independent preparation of clinical sections of IND, BLA, or NDA, • Demonstrated ability to write and present clearly using on scientific and clinical issues terminology, • Experience with management of multinational clinical trials, • Experience in interactions with outside vendors, e.g., CROs and contract labs, • Demonstrated matrix leadership skills, • Detailed knowledge of regulations and guidelines, • Excellent organizational and planning skills, • Demonstrated ability to write and present clearly using on scientific and clinical issues terminology, • Strong interpersonal skills and communication skills (both written and oral), • Ability to work effectively in a team/matrix environment, • Applies strong analytical and business communication skills JOB COMPLEXITY: • Capable of anticipating, identifying, prioritizing and resolving task-related challenges, • Ability to write and present clearly especially on scientific and clinical issues, • Ability to work effectively in a team/matrix environment, • Excellent interpersonal, organizational, supervisory and project planning skills., • Demonstrated professional collaboration skills DESIRED BEHAVIORS: • Approaches problems and solutions with an enterprise mindset, considering broad impact to portfolio, regional and global functions, • Ability to study, analyze and understand new situations and business problems and identify appropriate solutions, • Curious in planning; agile in execution, • Operationally excellent and drives others towards excellence, • Resilient in the context of a rapidly changing environment, • Organized with a systematic approach to prioritization EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS: • We drive for results, so patients can survive and thrive., • We are resilient in the face of adversity, and tireless in advancing our science., • We celebrate our long history of prolific drug discovery and rigorous drug development., • We unite to launch innovative medicines for difficult-to-treat cancers., • We exist to give people hope - one drug, one patient at a time., • We are Exelixis. LIVES THE EXELIXIS CORE VALUES DAILY: • Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way),, • Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results), • Excel for Patients (Innovate to design solutions and remove barriers to show how much we care) WORKING CONDITIONS: • Travel may be required up to 20% in support of clinical study activities #LI-JD1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $172,000 - $245,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

SUMMARY/JOB PURPOSE: The Clinical Data Management (CDM) Director is a highly experienced and influential leader with expert knowledge of Clinical Data Management concepts and processes. This position is accountable for the operational leadership of CDM activities across all solid tumor oncology clinical studies Phase I to IV, with organizational scope in various resourcing models across geographic regions. For the CDM Director, this position provides strategic and executional support from the Data Science & Biometrics (DSB) organization with the goal of achieving a complete and high-quality database. These positions serve as the eyes and ears of CDM/DSB, provide leadership in data completeness and quality, key contributors to the data collection and quality strategy, and provide cross-functional leadership in these areas. This role requires a well-established CDM Lead, with a recognized track record of leading the delivery of clinical data management activities. This role has independent decision-making authority for delivery of the studies aligning to timelines and budgets set by the study teams. * This position is located at Exelixis beautiful headquarters overlooking the bay in Alameda, CA. Full relocation provided. ESSENTIAL DUTIES AND RESPONSIBILITIES: • Key member of the CDM Team with accountability for delivery of all clinical trials Phase I to IV with a combination of internal FTEs (matrixed), Functional Sourcing Provider (FSP) or fully outsourced resources with a combination of on-shore and off-shore resources., • Align with Business, Functional, and TA Heads/teams on key portfolio objectives and priorities to develop and influence the strategy and direction of CDM. Interacts with Produce Development & Medical Affairs colleagues, therapeutic or functional area leaders to execute on the organizational priorities, with a focus on quality CDM/DSB deliverables., • Excellent organizational ability to manage CDM workload and ensure appropriate resource allocation is in place for optimal portfolio support. High level of vendor engagement/utilization., • Decision-making has direct impact on the direction and effectiveness of the study as well as the portfolio level due to the scope and span of area of responsibility., • Provide a leadership role in department process development and optimization of related clinical research activities. Lead or support the initiatives to drive change within CDM/BSD as well as across PDMA from a clinical data perspective., • Align processes and priorities across the portfolio to maximize organizational effectiveness; design and implement innovative approaches to enhance productivity and effectiveness. Work with leadership to ensure the department strategy and processes are clear towards all stakeholders with optimal communication and engagement., • Contributes to development and analysis of performance metrics and identifies ways to raise standards at the study as well as department level. Responsible for study team adherence to standards and compliance., • Strong customer focus and belief in Exelixis values; creates a positive value-based work environment for the CDM department. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: • BS/BA degree in related discipline and a minimum of 13 years of related experience; or,, • MS/MA degree in related discipline and a minimum of 11 years of related experience; or,, • PhD in related discipline and a minimum of 8 years of related experience, or;, • Equivalent combination of education and experience., • May require certification in assigned area. Experience/The Ideal for Successful Entry into Job: • Typically requires a minimum of 15 years of related experience and/or combination of experience and education/training., • Experience in Biotech/Pharmaceutical industry required., • Experience in Oncology clinical trials is preferred., • Experience leading change initiatives is preferred., • Demonstrated experience leading global data management activities is required., • Experience participating in regulatory submissions and inspections is required., • A minimum of 8 years of leading teams in a highly matrixed organization., • Excellent understanding of clinical development, quality and regulatory standards (e.g., CDISC) and policies relevant to Data Management and risk based data management approach of clinical data (e.g., GCP, ICH). Knowledge/Skills: • Has extensive experience in relevant industry/profession., • Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways., • Develops technical and/or business solutions to moderate complex problems., • Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results., • Guides the successful completion of major programs, projects and/or functions., • Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing., • Has complete understanding and wide application of technical principles, theories, concepts and techniques., • Has strong knowledge of other related disciplines., • Applies strong analytical and business communication skills., • Ability to identify, author, maintain and train staff on key data management SOPs and work-practice guidelines., • Knowledge of Good Clinical Practices (GCP) is essential., • Demonstrated success managing data management activities of Clinical Research Organizations (CROs). JOB COMPLEXITY: • Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles., • Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results., • Creates formal networks involving coordination among groups. #LI-JD1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $181,500 - $258,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

The Associate Director, Clinical Study Management, will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our California office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world class inhouse clinical study management. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. About You You are collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology. What You’ll Do • Team leader and builder, who manages clinical trial deliverables, timelines, and budgets per the Clinical Development and Operational Plans, • Works with minimal oversight from the Clinical Operations Senior Director or Director, in collaboration with Clinical Study Management teams and Clinical Research and Development functional teams, • Demonstrate broad understanding of therapeutic and clinical drug development expertise to influence study design and program-level decisions, • Provide direction to cross-functional study teams to ensure successful study execution Ensure that clinical studies are conducted following approved protocols, FDA Regulations, ICH-GCP, EMA, PMDA, other relevant regulations, directives, and guidelines, and company procedures and quality documents, • Oversee risk identification, assessment, and mitigation strategies to ensure patient safety and data integrity, • Responsible for the implementation of processes and systems that will facilitate inspection readiness throughout the lifecycle of the trial., • Oversee the preparation and maintenance of detailed clinical trial project timelines, • Manage ancillary (non CRO) vendor relationships and performance to ensure that clinical studies are completed following contract specifications of time, cost and quality., • Work with finance, legal, and external vendors to ensure the assigned studies are meeting the target milestones, • Provide regular updates on study progress to stakeholders (e.g., Clinical Operations, Project & Portfolio Management, Clinical Research), • Ensure that all study-related documents are accurate, complete, timely and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems., • Responsible for hiring, performance management, career development, and providing mentorship to Clinical Study Management personnel., • Contribute to initiatives and projects adding value to Eikon Therapeutics Qualifications • Minimum of 10 years of related experience with a Bachelor’s degree or 8 years and a post-graduate degree., • Experience leading large, global clinical trials, preferably in oncology, • In-depth knowledge of ICH-GCP, EMA guidelines and other relevant regulations and guidelines., • Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety., • Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams., • Experience with management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery., • High sense of accountability and urgency to prioritize deliverables., • Growth mindset and capable of working independently.

Job Title: Associate Director Clinical Operations Location: San Francisco (Hybrid 1-3 days a week Onsite) Reports To: Executive Director, Clinical Operations Overview We are seeking a strategic and execution-focused Associate Direcctor of Clinical Operations with deep experience in ophthalmology to support the design and delivery of clinical programs. This individual will support the end to end operational execution of clinical trials across retinal and anterior segment indications, ensuring high quality, efficient study conduct in alignment with regulatory expectations. This role requires a leader who understands the unique complexities of ophthalmic trials, including specialized endpoints, imaging modalities, site dynamics, and patient recruitment challenges. Key Responsibilities Clinical Operations Leadership • Provide strategic leadership for all clinical operations activities across ophthalmology programs (Experience in Retina is highly desired), • Build, lead, and mentor a high performing clinical operations team, including Clinical Trial Managers, CRAs, and in-house staff, • Develop and scale infrastructure, SOPs, and operational frameworks tailored to ophthalmic trials, • Collaborate cross functionally with Clinical Development, Regulatory, Biostatistics, Data Management, and Medical Affairs Trial Execution and Delivery • Oversee planning, startup, execution, and closeout of global ophthalmology trials across Phase I through Phase III, • Ensure delivery against timelines, budgets, and quality standards, • Manage study risks specific to ophthalmology, including enrollment challenges, variability in visual acuity endpoints, and imaging consistency, • Drive site selection strategies focused on high enrolling ophthalmology centers and key opinion leader networks Ophthalmology-Specific Expertise • Oversee implementation and standardization of ophthalmic endpoints such as BCVA, OCT imaging, visual field testing, and intraocular pressure measurements, • Ensure proper vendor selection and oversight for central reading centers, imaging vendors, and specialized ophthalmic CRO capabilities, • Maintain consistency and quality in imaging data acquisition and grading across sites, • Guide protocol development with a strong understanding of ophthalmology trial design and patient pathways Vendor and CRO Oversight • Lead selection, contracting, and oversight of CROs, central labs, imaging vendors, and specialty providers, • Establish clear performance metrics and ensure accountability across all external partners Quality and Compliance • Ensure all studies are conducted in accordance with GCP, ICH guidelines, and global regulatory requirements, • Maintain inspection readiness and lead audit and inspection responses, • Implement quality oversight processes with a focus on data integrity, especially for imaging and functional endpoints Operational Strategy and Scaling • Contribute to overall clinical development strategy with an operational lens specific to ophthalmology, • Identify and implement innovative approaches to improve patient recruitment, retention, and site performance, • Support global expansion strategies, including geographic considerations for ophthalmology trials Budget and Resource Management • Develop and manage clinical operations budgets across multiple ophthalmology programs, • Forecast and allocate resources aligned with pipeline priorities, • Drive cost efficiency while maintaining high quality study execution Qualifications • Bachelor’s degree required. Advanced degree preferred, • 10+ years of clinical operations experience in biotech or pharma, with significant focus in ophthalmology (Retina), • Proven experience leading global ophthalmology clinical trials, including retinal or anterior segment indications, • Strong expertise in ophthalmic endpoints such as BCVA, OCT, FAF, visual fields, and IOP, • Demonstrated success managing CROs, central reading centers, and imaging vendors, • Deep understanding of GCP, regulatory requirements, and ophthalmology-specific trial considerations, • Strong leadership, communication, and cross functional collaboration skills, • Ability to operate strategically while remaining hands on when needed

Our On-Demand Talent Solutions team is partnering with our trusted client to identify a Director-level Clinical Scientist. Our client is a biopharmaceutical company developing next-generation targeted therapies for cancer. This role is ideal for a drug development professional passionate about translating innovative science into meaningful clinical outcomes. Summary: The Clinical Scientist will lead aspects of protocol development, study planning, data generation, analysis, and reporting as well as work cross-functionally to deliver high-quality data and insights that move programs forward. Responsibilities: • Lead design and execute clinical deliverables to support the CDP, including INDs, protocols, IBs, and study documents (CRFs, SAPs, data listings)., • Oversee clinical data generation, validation, and review, including query resolution, patient eligibility, and protocol deviation management., • Perform study subject-level data analysis to inform clinical development strategy and reporting., • Partner with medical teams, advisors, and Health Authorities, including support for HA/IRB interactions and responses., • Contribute to therapeutic area research, KOL/investigator engagement, and development of scalable clinical processes. Qualifications: • A minimum of 8 years of relevant experience and an advanced degree (PharmD, PhD, MD, MSN, PA, MPH, etc.), • Strong background in small molecule therapies and oncology clinical development., • Experience in hematology required., • Experience in early phase clinical trials required.

Overview Our client is a fast-growing biotechnology company seeking a Senior Biostatistician (Associate Director level) consultant to support their Biometrics team. This role requires an experienced statistician who can function both as a study lead and as a supporting statistician, depending on project needs. This is a hands-on role in a fast-paced biotech environment, where the successful candidate will collaborate closely with cross-functional teams and take ownership of delivering high-quality statistical support across clinical trials. Key Responsibilities • Lead or support biostatistical activities for clinical trials, depending on study needs., • Contribute to the design, analysis, and interpretation of clinical trial data., • Develop and review statistical analysis plans (SAPs) and other study documentation., • Collaborate with cross-functional teams including Clinical Development, Data Management, Statistical Programming, and Regulatory., • Ensure timely delivery of statistical analyses and study outputs aligned with clinical timelines., • Provide statistical input for clinical study reports, regulatory submissions, and publications., • Participate in protocol development and study design discussions., • Communicate statistical concepts and results clearly to both technical and non-technical stakeholders. Required Qualifications • MS in Statistics or Biostatistics and 7-8+ years of experience in pharma or biotech clinical development, • Experience working in small biotech environments (required); preferable to have experience working both small and large sponsor organizations with strong tenure., • Demonstrated ability to function as both Lead Statistician and Supporting Statistician, supporting multiple clinical trials simultaneously, • Strong experience across a variety of therapeutic areas (non-oncology), • Experience with placebo-controlled clinical trials, • Strong knowledge of statistical methodologies used in clinical trials, • Excellent written and verbal communication skills, • Ability to operate effectively in a fast-paced, collaborative environment

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Digital Marketing Specialist-Patient Recruitment will develop and manage clinical trial recruitment campaigns. This includes designing, executing, and optimizing omni-channel campaigns that drive patient awareness, education, and enrollment in clinical trials. This position will sit at the intersection of digital marketing, patient advocacy, and clinical operations, and apply a strong understanding of regulated pharmaceutical advertising, data-driven marketing, and performance measurement. This role is both strategic and hands-on and will manage campaigns in-platform while collaborating cross-functionally with Clinical Operations, Medical Affairs, Legal/Regulatory, and external agencies. Essential Functions • Develop and implement multi-channel patient recruitment campaigns, including medical congress support, digital media strategies, and content development, to support patient recruitment for clinical trials across indications and geographies, • Plan, launch, and optimize paid media campaigns across channels including Meta (Facebook/Instagram), Google Search & Display, YouTube, Programmatic, and disease-specific patient communities and advocacy platforms, • Align media plans with study timelines, enrollment targets, and budget parameters, • Monitor campaign performance in real time and optimize for: cost per lead (CPL), conversion rates (CR), qualified patient submissions, site referrals, and enrollment progression, • A/B test creative, messaging, audiences, and landing pages to improve performance, • Partner with analytics teams/agencies to track attribution and patient journey metrics, • Work with internal teams and agencies to develop compliant, patient-centric digital content including ad copy, visual assets, landing pages, and educational materials, • Ensure all creative aligns with regulatory, legal, and brand guidelines, • Collaborate closely with Clinical Operations (to align enrollment needs and timelines), Medical Affairs (to ensure scientific accuracy), Legal/Regulatory/PRC (to ensure compliance), Patient Advocacy (to align community engagement), external media, and creative agencies, • Manage digital media budgets and pacing, • Oversee relationships with media agencies, publishers, and technology vendors, • Negotiate placements, pricing, and performance-based agreements where applicable, • Produce regular performance reports and insights for internal stakeholders, • Identify trends, risks, and opportunities to improve recruitment efficiency, • Stay current on digital trends, privacy changes (e.g., HIPAA, GDPR, platform policies), and evolving best practices in patient recruitment marketing, • Perform ad-hoc and cross-functional duties and/or projects to support business needs and provide developmental opportunities Education & Experience • Bachelor's degree in Marketing, Journalism, Advertising, Communications, or related field with 5+ years of experience in digital media, performance marketing, or growth marketing required, • Experience in healthcare, pharma, biotech, CRO, or clinical trial recruitment is preferred, • Experience recruiting patients for clinical trials is preferred, • Experience working within highly regulated environments is preferred, • Experience working with patient advocacy groups is preferred Knowledge, Skills, & Abilities • Data-driven mindset with ability to interpret performance metrics and act on them, • Excellent communication and stakeholder management skills, • Analytical and performance-oriented, • Detail-oriented with strong project management skills, • Comfortable working in cross-functional, fast-paced environments, • Able to balance creativity with regulatory constraints, • Strong written and verbal communication skills, • Familiarity with IRB/ethics considerations in patient recruitment is preferred, • Knowledge of patient privacy regulations (HIPAA, GDPR) is preferred Working Environment / Physical Environment • This position works remotely - San Francisco, CA, • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • This position will require some travel (approximately 3-4 trips per year)., • Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $135,000 (entry-level qualifications) to $148,500 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit _ for more information. Brief Description: The Medical ScienceLiaison (MSL) is a member of a field-based team of scientists who function as an extension of the US Medical Affairs organization. MSLs are responsible for developing and enhancing professional relationships with medical thought leaders involved in various phases of product development. MSLs provide medical information through scientific exchange, and clinical/scientific support for Jazz Pharmaceuticals and the Medical Affairs department. This is afield-based position coveringNorthern California, Washington, Oregon, Alaska, Idaho, & Montana, and requires professionals with established personal and scientific credibility to interact with thought leaders and academic centers of excellence. Essential Functions KOL Development andField Engagement: Identify and develop peer-to-peer relationships with key opinion leaders (KOLs) and healthcare providers within the therapeutic area Develop and execute territory plans in alignment with US Medical Affairs plans Identify and communicate key clinical and research issues and insights from KOLs to appropriate departments Participate in medical education for healthcare professionals (HCPs) through on-site presentations at healthcare institutions, investigator meetings, national conferences, advisory boards, or regional meetings Provide scientific supportfor additional activities such as medical congress staffing, advisory boards, and sales training initiatives Positions self asScientific Expert Maintains an up to date andhigh-levelknowledge of the therapy area,Jazz products, new and emerging areas of research, therapeutic issues and trends, and competitive landscape. Establishes reputation as a trustworthy and knowledgeable source of scientific and medical information for the healthcare community. Supports development of Jazz Pharmaceuticals positioning as the scientific authority inthe therapeutic area. Attendsappropriate scientific congresses to stay abreast of developments and to supportRegional, National and localKOL activitiesand Jazz interests. Acquires a broad understanding of local and national protocolsand standardsof clinical practiceand trends in disease managementin the US. Provide clinical presentations and information in response to unsolicited questions (as appropriate) in academic, community, and healthcare provider settings in both group and one-on-one situations Communicatesemerging data andthe clinical experiencewith our products through scientific exchange and peer-to-peer interactionsdiscussing benefits and risks in an objective manner. Provide support for data generation activities (company-sponsored studies, collaboration studies, ISTs) Provide scientific support for additional activities such as medical congress staffing, advisory boards, and sales training initiatives. Medical Affairs PlanningandPlan Execution Contributes to the development of theUSMedical Plan and provides input into local strategies and tactics. Where needed,managesrelevant budget to enable execution of Medical Plantactics as part of the wider Medical Affairs team. Works in a collaborative manner with cross-functional colleagues to ensure a Key Account Management approach. Interactswith HCPs as a scientific resource to support activities aligned with the Medical Plan including advisory boards, speaker development and clinical trials. Responsible for maintainingCompany standardsand Jazz Values Consistently actstoenhanceJazzPharmaceuticals' image as an advocate of medical advancement by using knowledge of product, disease state and pipeline products to engage healthcare providers in meaningful scientific exchange of information. Document and forward reports of adverse eventsand product complaintsaccording to Jazz's policy to ensure safe and effective use of Jazz Pharmaceuticals' products. Adheresto the relevant national and local Codes of Practice. Behaves ethically and with integrity at all times. Actsas an ambassador for Jazz Pharmaceuticals following company mission and values. Keepsown written development plan and implements. Preparestimely reporting according to the company needs. Required Knowledge, Skills,and Abilities Required Ability to research and critically analyze and communicate complex scientific and medical information and data. Clear and concise communication and presentation skills. Excellent planning and organization skills, with high-level attention to detail and accuracy. Strong strategic mindset. Highly self-motivated and ability to work autonomously. Ability to learn quickly, be flexible and results-focused in a rapidly changing environment. Excellent negotiation skills. Demonstrated skills in inter-personal relationship building, networking, collaboration and teamwork. Strong capabilities working with digital platforms and tools are required Excellent command of spoken English. Ability and willingness to travel at least 60% of workdays. Driving required. Preferred Knowledge of geography, healthcare environment and external experts in academia and medical community. Demonstrated ability to develop trust and relationships with opinion leaders in disease states of interest. Understanding of regulatory requirements for field-based personnel Experience in oncology Experience as a Medical Science Liaison with a strong track record of success is strongly preferred Required/Preferred Education andLicenses Advanced degree (PharmD, MD, PhD or equivalent) with a minimum of 3 years' experience in the therapeutic area of interest. License (RN, NP, CNP, PA or equivalent) with a minimum of a Master's Degree (or equivalent) and a minimum of 5 years' experience in clinical practice. A minimum of 2 years' experience as a MSL or comparable industry or clinical role is required. This is a field position and applicants must be willing to travel 60-70% time Valid driver's license and live within 60 miles of a major airport Description of PhysicalDemands Frequent travel between meeting sites. Frequently operating a computer, printer, telephone and other similar office machinery. Description of WorkEnvironment Frequent interactions with external contacts in their office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes. Frequent computer laptop or tablet use, not usually at a workstation. Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands. Frequent public contact requiring appropriate business apparel. #LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $160,000.00 - $240,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: _.

Position Title: Study Start Up Lead (SSUL) Work Location: South San Francisco, CA, 94080 Assignment Duration: 12 Months Work Arrangement: Onsite Position Summary: As a member of the PDG Country Study Start-Up Team, your primary focus is to drive and facilitate efficient study start-up processes to contribute to the delivery of clinical trials to patients. You will enable innovative clinical trial delivery, address study start up needs across various therapeutic areas, and ensure seamless trial execution for patients, investigators, and clinical site staff. Background & Context: This role focuses on the efficient and compliant initiation of our organization-sponsored clinical trials by developing and implementing effective start-up strategies, overseeing start-up operations, and driving process improvements at the country and site level while maintaining regulatory compliance. Key Responsibilities: • Leading the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders., • Overseeing start-up operations and ensuring timely and efficient site activation and regulatory compliance., • Ensuring alignment with global strategies and timelines., • Managing amendments throughout the study lifecycle., • Identifying and driving opportunities for process automation, standardization, and innovation., • Collaborating with regional and global counterparts to harmonize systems and improve timelines., • Participating in external industry collaborations to influence country start-up environments., • Engaging with government and institutional bodies to align on clinical trial policies and practices (e.g., with Ethics Boards, Health Authorities). Study Start-Up Strategy & Execution: • Lead teams in the creation of the study start-up strategy and execution of the study start-up process, encompassing strategy development, proactive risk mitigation, regulatory compliance, stakeholder liaison, tracking, knowledge management, and collaborative planning with CRO partners. Informed Consent Form (ICF) Management: • Architect and strategically oversee ICF management, including preparation, submission, archiving to ensure compliance, alignment with the corporate requirements and best practices. Clinical Trial Submissions & Regulatory Coordination: • Lead the development and oversight for clinical trial submissions, amendments and regulatory coordination, managing packages, responding to queries, ensuring document maintenance, and supporting amendments throughout the trial lifecycle. Site Documentation & Compliance: • Strategically manage site documentation and compliance, overseeing document collection/validation, coordination of related processes, and local vendor management (excluding CROs) if needed., • Oversee translation and approval of drug labels and patient-facing materials, as required., • Maintain up-to-date knowledge of country-specific regulations, including those for medicinal products, medical devices, and IVDRs. Budgeting & Contract Management: • Provide comprehensive strategic planning, oversight and implementation for all aspects of budgeting and contract management, including developing Fair Market Value-based budget strategies and drafting clinical site budgets, negotiating and implementing contracts, confidentiality disclosure agreements, indemnity/insurance documentation, and amendments, ensuring financial and legal alignment through collaboration with internal and external stakeholders, and maintaining accurate contract data in systems to support effective planning and forecasting. Payment Oversight: • Strategically oversee the payment processes, escalations, and reporting, ensuring financial/regulatory contract compliance and participating in planning, management, and reconciliation of financial activities. Qualification & Experience: • Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent. Postgraduate degree or master's degree highly desirable., • Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration., • Strong understanding of ICH-GCP, EU CTR, and local regulatory environments., • Experience managing vendor/CRO relationships., • Proven leadership or line management experience (for PLs). Skills & Competencies: • Excellent communication and interpersonal skills., • Strong organizational, analytical, and problem-solving capabilities., • Proficiency in clinical systems (Veeva Vault, CTIS, RIM, etc.)., • Collaborative and adaptable mindset with attention to detail., • Ability to lead through complexity and ambiguity, especially in matrixed and global teams., • Fluency in written and spoken English is mandatory., • Fluency in written and spoken language(s) of the host country is mandatory.

Job DescriptionBreezeBio is a rapidly-growing, early-stage company that is developing a proprietary and novel delivery platform with the potential to transform genetic medicine. Our interdisciplinary team works together across chemistry, payload design, formulation, and screening and preclinical groups to develop the next generation of gene therapies. BreezeBio fosters an exciting and dynamic environment where we value impactful data and creative solutions to accelerate our progression from a platform technology to a pipeline of therapeutic candidates. We are seeking talented and motivated individuals to join our team and are expanding across all functions within the organization. Join us in South San Francisco, CA, to be at the forefront of the future of gene therapy. Senior Consultant, CMC Development and Manufacturing BreezeBio is looking for an individual who will provide technical and organizational leadership and work closely with cross-functional stakeholders to ensure CMC activities are executed seamlessly and in alignment with the integrated product development plan and program timelines. The individual will lead the management of manufacturing of established drug substances and drug products for late-phase clinical trials and the development of new products. The individual will also contribute to the overall CMC strategy, planning, and execution; provide regulatory documentation for all phases of clinical trials and commercialization; and play a role in CDMO management for other CMC areas including analytical and drug product. The senior consultant will be a contributing member of the R&D management team to plan and execute on company objectives and R&D strategy for all programs. This person must be a strong scientist with a sound track record of technical expertise and organizational leadership, early and late stage CMC.and a knowledge of the drug discovery process from exploratory research to IND submission. This person must be able to guide and drive project teams to make decisions and recommendations to the executive team, is a critical and creative problem solver, and comfortable in a dynamic, start-up environment to find solutions to scientific, technical, and resource allocation issues to move programs forward. The ideal candidate will be a team player with excellent communications skills and work collaboratively across all functions within the company and with external partners. Responsibilities·Key polymer synthesis and development and manufacturing operations to maintain and advance company pipeline.·Manage and maintain project timelines for CMC activities in support of early and late-phase clinical trials, ensuring strategy and roadmaps align with and feed into company goals and project timelines.·Manage in-house CMC personnel and external subject matter experts.·Lead CDMO and other vendor identification, assessment, qualification, and management with adequate risk assessment.·Manage tech transfer, process familiarization, and manufacturing at CDMOs to ensure timely delivery of GMP drug substance and drug product.·Contract and Quality Agreement negotiation.·Develop and carry-out a QBD approach to identify CPPs in support of CQAs for efficacy and safety of drug substance.·Author/review/approve the relevant CMC sections to enable global regulatory filings.·Generate, review, and/or approve study protocols, development reports, and manufacturing batch records.·Manage developmental stage-appropriate analytical activities.·Communicate CMC strategy and project status to key stakeholders cross-functionally and assist in driving decision-making.·Collaborate with cross-functional teams (clinical development, clinical operations, regulatory affairs, quality, IP) to ensure CMC and program goals are met. Education and Qualifications:·PhD in polymer chemistry or polymer science and engineering with industry experience in synthesis scale-up and downstream processing, ideally in a therapeutic drug context.-10+ years in industry CMC; 3+ years of experience as CMC team leader, managing team members and projects.·Proven success in vendor management, specifically CDMOs, with track record of negotiating contracts and completion of projects on time and within budget.·Successful management of CDMO to manufacture GMP product for late-phase clinical trials is a requirement.·Thorough understanding and working experience in drug substance development and manufacturing with respect to quality by design, GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements. Experience writing CMC section of NDA is a plus.·Experience with key analytical techniques: NMR, GPC-RI, HPLC, UV-vis, fluorescence spectroscopy, DSC, ITC, MAL-SEC, and other characterization methods.·Highly motivated scientist with particular attention to detail and the ability to independently plan, design and implement experiments·Excellent written, verbal and presentation skills·Work authorization in the US is required At BreezeBio we are always looking to hire the absolute best talent and recognize that diversity in our experiences and backgrounds is what makes us stronger. We hire candidates of any race, color, ancestry, religion, sex, national origin, sexual orientation, gender identity, age, marital or family status, disability, veteran status, and any other status. These differences are what enable us to work towards the future we envision for ourselves, and the world. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description As an Account Executive (SMB), you will sell a generative AI SaaS platform for regulatory document creation and workflow management to small biotech startups running 6 or fewer clinical trials. You will be selling primarily to Heads of Regulatory Affairs, Heads of Drug Development, CMOs, and Heads of AI for Regulatory at lean, fast-moving organizations where approximately 2 stakeholders make decisions. There are two separate openings: one covering SMB West (all states west of the Mississippi River) and one covering SMB East (all states east of the Mississippi River). Both roles are fully remote and report directly to the VP of Sales. The base salary is $120,000 – $140,000 USD, plus commissions. COMPENSATION & BENEFITS • • $120,000 – $140,000 USD base salary, plus commissions, • • Year 1 OTE: $240,000 – $280,000 USD (base salary doubled at quota), • • Uncapped commission — accelerators apply for overachievement; no ceiling on earnings, • • Commission paid monthly, • • Stock options, • • Company-paid health, dental, and vision benefits, • • OneMedical, TalkSpace, and Teladoc included, • • 401K matching, • • Laptop provided, • • Clear career advancement path — direct route to Senior AE or Mid-Market AE as the company scales THE COMPANY & CULTURE Our client is a venture capital-backed, early-stage SaaS company experiencing 100-200% annual revenue growth. Headquartered in San Francisco, CA, with a team of 35 employees company-wide. The company provides a generative AI platform that creates, reviews, and edits regulatory documents throughout the biotech and pharmaceutical drug development lifecycle. Clients use the platform to shorten regulatory submission timelines, reduce resource requirements for complex filings, and produce higher-fidelity regulatory documents --- addressing a compliance-driven, mission-critical workflow where errors carry significant consequences. OFFICE LOCATION & SALES TERRITORY • • Head Office: San Francisco, California, • • Work arrangement: Fully remote, • • West territory: All states west of the Mississippi River — San Francisco Bay Area, San Diego, Seattle, Houston and Phoenix / Scottsdale area., • • Candidate must be located within their assigned territory, • • Client-facing work: in-person prospect and customer meetings within territory; up to 50% overnight travel required for meetings, trade shows, and industry events, • • Driver’s licence required — field visits to client locations expected, • • Hours: Monday to Friday, standard business hours; no required evening or weekend client commitments EXPERIENCE, BACKGROUND & EDUCATION REQUIREMENTS • • 2 to 3 years of B2B sales experience with an emphasis on SaaS software sales — documented quota-carrying AE or full-cycle sales experience required; business development-only and services-only backgrounds are not a fit, • • Life sciences industry background highly desirable — biotech, pharma, CRO, healthcare IT, or regulatory technology; must be able to hold a credible conversation about pharmaceutical drug development and regulatory filing processes with senior buyers, • • Experience selling to VP and Director-level buyers and C-suite executives at biotech or pharma organizations, • • Familiarity with MEDDIC or a comparable structured sales methodology preferred, • • Must be located within the assigned territory, • • Must be willing to travel up to 50% within the territory, • • Driver’s licence required, • • Bachelor’s degree in Life Sciences, Business, or a related field required, • • Knowledge of FDA, EMA, or ICH regulatory guidelines is a plus but not required TECHNICAL SKILLS • • CRM: HubSpot preferred; Salesforce or Tableau also acceptable, • • Sales engagement tools: Salesloft or equivalent sequencing platform, • • Prospecting and enrichment tools: LinkedIn Sales Navigator, ZoomInfo, WIZA, or similar, • • Standard proficiency in Microsoft Office required, • • Genuine comfort with AI and automation tools in day-to-day sales workflow THE PRODUCT / SERVICE / SOLUTION • • Generative AI SaaS platform for creating, reviewing, and editing regulatory documents used in biotech and pharmaceutical drug development, • • Platform shortens regulatory submission timelines, reduces resource requirements, and improves document fidelity across the drug approval process, • • Particularly valuable for small biotech startups where regulatory speed and lean resources are critical to clinical timelines, • • Sold as a software license (SaaS) PROSPECTIVE CUSTOMERS / INDUSTRY FOCUS / DECISION MAKER(S) • • Small biotech startup companies running 6 or fewer clinical trials — lean organizations where speed and resources are at a premium, • • Geographic focus: SMB West (all states west of the Mississippi) or SMB East (all states east of the Mississippi), depending on the role, • • Primary decision-makers: Head of Regulatory Affairs, Head of Drug Development, CMO, Head of AI for Regulatory, • • Deals typically involve approximately 2 decision-makers per transaction SALES CYCLE / ORDER VALUE / ACCOUNT SIZE • • Average deal size: $30,000 to $100,000, • • Average sales cycle: approximately 90 days, • • Selling is primarily conducted by phone and video; in-person meetings occur but this is not a face-to-face-heavy role COMPETITIVE ADVANTAGES • • Purpose-built generative AI platform for regulatory document workflows — not a generic AI tool adapted for life sciences use, • • Directly addresses the most costly and time-sensitive constraint in drug development: regulatory submission timelines, • • Demonstrated results with blue-chip clients, including Takeda and Parexel — credibility that translates to smaller biotech buyers, • • PE-backed with aggressive investment in product development and go-to-market growth, • • Low turnover culture and experienced, mentorship-focused VP Sales leadership TYPICAL DAY & DUTIES • • 100% New Business Development, • On a typical day, you will be conducting high-volume outbound prospecting via phone, email, LinkedIn, and video to small biotech startups across your territory; running qualification calls, product demos, and closing conversations; managing a fast-moving pipeline of 90-day deals in HubSpot CRM; and collaborating with the Marketing team on outbound campaign strategy. This role rewards high daily activity and tight pipeline discipline — deal velocity is higher than mid-market, and the best performers thrive on the pace. LEADS • • Approximately 75% self-generated through outbound prospecting — phone, email, LinkedIn Sales Navigator, and enrichment tools, • • Approximately 25% from marketing campaigns, list-based targets, webinars, and industry events OVERNIGHT TRAVEL • • Up to 50% overnight travel required, • • Travel is for in-person prospect and customer meetings, trade shows, conferences, and industry events within assigned territory SUPPORT & TRAINING • • Direct reporting relationship with the VP of Sales — 30+ years of sales leadership experience, MEDDIC-focused coaching, Work Hard Play Hard philosophy, • • Collaborative team of 8 existing AEs; culture of information sharing and peer-to-peer learning, • • Full product and regulatory domain onboarding provided — industry knowledge is highly desirable but Weave Bio will train on the platform, • • Partnership with Marketing Director on outbound campaign strategy and territory coverage WHY YOU SHOULD APPLY • • Uncapped earnings with high deal velocity — shorter 90-day cycles mean faster commission checks; the current top performer company-wide reached $370,000+ OTE in their first year, • • Open territory with no existing account load — the entire SMB biotech market in your half of the country is yours to build, • • Clear career path to Senior AE or Mid-Market AE — as Weave Bio scales, strong performers move up; this is an early-entry opportunity at a company in aggressive growth mode, • • Mission-driven product — you are selling technology that accelerates the path to life-saving drugs reaching patients; that matters to your buyers, and it will matter to you, • • Strong, low-turnover culture under an experienced VP Sales who invests in coaching and developing the people on his team Equal Opportunity Employer Just Sales Jobs and our clients are equal opportunity employers. We do not discriminate. All candidates are evaluated solely on performance merit and organizational fit. Not the Right Fit? We May Have Other Roles for You. If this particular role isn’t the right match, we encourage you to browse our other open positions at https://justsalesjobs.ca/jobs-opening/ and apply for any that interest you. Our recruiters review every resume we receive — and if we have another role that could be a great fit for your background, we will reach out to you directly #IND10

Job Description Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name "Erasca" has an important embedded meaning: it is a contraction of our audacious hope to "erase cancer" that drives our mission and everything that we do on behalf of patients with cancer. Reporting to the Chief Medical Officer, the SVP Late Clinical Development will provide medical leadership and oversight of late-stage clinical trials and collaborate with the CMO across the Erasca portfolio. In addition, the SVP will be a hands–on drug developer and will serve as clinical lead and/or medical monitor on programs or studies. A key area of focus will be the design and execution of multiple registration enabling trials in solid tumor indications. Essential Duties and Responsibilities: • Provide medical direction and high-quality scientific and clinical knowledge to guide the strategy and execution of late-stage clinical programs and contribute to clinical decision making across the Erasca portfolio. Participate in building and maintaining a culture of rigorous data-driven decision making., • Lead late clinical development function, directly and through reports., • Responsibilities will include clinical development strategy, protocol development, registrational strategy, KOL and academic site interactions, competitive landscape diligence, presentation of data, and other clinical deliverables., • Serve as Medical lead on clinical programs and represent Clinical Development on program teams., • Design and implement novel and efficient registration enabling clinical trials to assess appropriate endpoints., • Responsible for leading clinical study subteams, monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data., • In collaboration with head of Medical Affairs, continue the establishment and execution of medical affairs strategy and tactics., • Contribute to regulatory filings including authoring clinical sections for NDAs and other related documents., • Partner with Drug Safety to assess the safety profile of compounds., • Write medical aspects of core study and regulatory documents including clinical research plans, protocols, investigator brochures, clinical study reports and regulatory submissions., • Contribute to the development and review of scientific publications; author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives., • Present at scientific, medical, and regulatory meetings., • Maintain a high level of clinical and scientific expertise by reviewing literature, attending medical or scientific meetings, and through personal exchange with thought leaders, investigators, and internal stakeholders and partners., • Participate in due diligence or other business development activities., • Recruit, retain, and develop high-functioning late clinical development team., • Establish, develop, and maintain relationships across Erasca, particularly with partners and stakeholders in Research and Development., • Perform all duties in keeping with the Company's core values, policies and all applicable regulations. Required Education and Experience: • M.D. degree or equivalent, with subspecialty fellowship training and board certification or eligibility in Oncology or Oncology/Hematology., • 12+ years of oncology clinical trial and drug development experience, including extensive experience in the pharmaceutical or biotechnology industry. The ideal candidate will bring a combination of clinical practice, academic clinical trials, and industry experience, with both large and small company experience a plus., • Direct management of medical and scientific staff in clinical development required; experience leading medical affairs function highly preferred., • Experience as the clinical lead on complicated global programs with multiple indications and studies required., • Experience leading or being closely involved in the clinical aspects of a regulatory filing and direct interaction with health authorities required., • Experience with product launch and commercialization highly preferred., • Experience in early development a plus., • Extensive knowledge of clinical trial methodology and the regulatory and compliance requirements governing clinical trials., • Executive leadership skills to represent late development on LT, educate and influence stakeholders, and add value in strategic business planning and decision-making., • Demonstrated ability to collaborate successfully with multiple functions in a matrixed team environment., • Effective interpersonal, communication and influencing skills, including excellent writing skills, with the ability to tailor communication style to diverse audiences and situations., • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment; a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex problems., • Strong learning orientation, curiosity, and commitment to science and patients. The anticipated salary range for this position is $400,000 to $465,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price. Along with our casual, collaborative, and fun work and the chance to make your mark in our mission to erase cancer, Erasca offers a comprehensive and competitive benefits package that includes: Paid Time Off, Holiday, and Sick Leave, Medical, Dental and Vision Plans, Short- and Long-Term Disability, Basic and Voluntary Life/AD&D Coverage, Flexible Spending Accounts (FSA, HSA, and Commute), Critical Illness and Accident Coverage, Pet Insurance, Employee Assistance Program, 401(k) Plan with Erasca contribution, and the opportunity to participate in an Employee Stock Purchase Program. Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.

Job DescriptionSalary: $180,000 - $195,000 POSITION DESCRIPTION Latigo is seeking a Senior Manager of Clinical Data Management to lead and oversee data management activities for assigned clinical studies, which includes, but is not limited to: CRF design and development, CRF standardization, ongoing data review and cleaning, rolling/interim/final database locks, and clinical data archival. They will work collaboratively with other internal and external clinical study team members across Clinical Operations, Biostatistics, Clinical Development and Translational Science. They shall be adept at utilizing and managing EDC systems, managing clinical data workflows and processes, and ensuring clinical trial data integrity and quality in their assigned studies to ensure high quality data in support of analysis for regulatory submissions, safety reporting and publications. Essential duties and responsibilities: • Manage and oversee CROs/vendors in clinical data management on clinical trials within assigned program., • Oversee the data management activities and deliverables from EDC build to final database lock and their timelines for assigned studies to ensure quality, efficiency and consistency., • Perform detailed reviews of data management specific plans and database specifications to ensure a built-in quality approach., • Perform User Acceptance Testing (UAT) on EDC, IRT and eCOA systems., • Develop study metrics reports and other reports as needed., • Work with vendors to set up and review data transfer specifications., • Oversee vendor data reconciliation (i.e. central laboratory data, SAE) to include quality control and timely review of queries., • Lead the creation of data review plans for internal cross-functional clinical data review activities., • Oversee EDC user administration and access for assigned studies., • Collaborate and communicate regularly with internal and external team members across other clinical trials and programs for consistency and standardization across programs to promote increasing efficiency., • Proactively identify potential issues affecting timeline, milestones, or deliverables, and propose strategies to mitigate or resolve., • Direct the development of CRFs and database design with cross-functional input and adherence to CDASH/CDISC standards and standards developed internally at Latigo Bio., • Participate in the creation of SOPs that are necessary for internal Clinical Data Management activities., • QC filing of data management documentation in the electronic Trial Master File (eTMF)., • Maintain internal data management study level documentation in audit ready status, as applicable., • Perform other duties as requested. Preferred Education & Experience: • Bachelors degree required, at a minimum., • 7+ years of relevant industry experience in clinical data management., • Self-motivated and highly flexible individual with a proven track record of successfully managing multiple tasks and priorities within a fast-paced environment with minimal oversight., • Excellent project management skills., • Great attention to detail with excellent interpersonal, organizational, written and verbal communication skills., • Proficiency in EDC systems (i.e. Medidata Rave) and other integrated clinical systems (e.g., IxRS/IRT)., • Working knowledge of ICH GCP and other regulatory guidance documents., • Working knowledge of CDISC/CDASH, GCDMP and other clinical data standards.

Job Description Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name "Erasca" has an important embedded meaning: it is a contraction of our audacious hope to "erase cancer" that drives our mission and everything that we do on behalf of patients with cancer. Position Summary: Reporting to a Sr. Clinical Project Manager of Clinical Operations, the Associate Clinical Trial Manager (aCTM) will assist in the implementation and conduct of clinical research projects and provide support for project teams. The position requires knowledge of clinical trial processes and experience in many aspects of trial execution from study start-up to close-out, including assisting in the management of clinical vendors or CROs and assisting in the oversight of resources, budgets, contracts, and timelines. The aCTM will also manage the creation, organization, maintenance, and quality of Trial Master File documents and maintain and support the Clinical Trial Master System (CTMS) platform. Essential Duties and Responsibilities: • Manage or assist in the management of large global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the protocol, ICH GCP, and local regulatory requirements., • Support key study-related activities and deliverables., • Support implementation of training programs ensuring relevant employees are trained as needed to ensure compliance with the protocol and other study-related documents., • Track study progress and maintain study status updates (e.g., site selection, IRB approvals, regulatory document collection, enrollment, SDV status, study drug inventory, clinical specimen tracking)., • Provide progress updates to relevant project teams and present a plan of action for resolution of issues (e.g., trial issues, investigator/study coordinator feedback, monitoring issues, patient enrollment issues)., • Maintain and support the eTMF and CTMS platform for clinical studies and operational workflows., • Manage user accounts, permissions, roles and eTMF/CTMS access., • Monitor eTMF/CTMS system performance, trouble shoot issues, and coordinate resolutions with vendor and/or study team members., • Support eTMF/CTMS system upgrades, patches, testing, and validation activities., • Maintain TMF structure and index according to ICH-GCP and Erasca SOPs., • File, classify, and index documents into the eTMF., • Perform ongoing review of trial TMF(s) to assure quality and compliance with relevant SOPs and ICH-GCP., • Track, triage, and resolve missing or nonconformant documents. Collaborate with study team members to obtain required documents and ensure timely filing., • Prepare and support regulatory and sponsor inspections/audits (document retrieval, audit trails, and corrective actions)., • May conduct (co)monitoring visits (pre-study, initiation, monitoring, and closeout) with contracted monitors/CRO., • Perform all duties in keeping with the Company's core values, policies, and all applicable regulations. Required Education and Experience: • Preference for undergraduate degree in Biological Sciences or professions (pharmacy, medicine, nursing, or other allied health sciences) with a minimum of 1- 2 years of relevant experience., • At least 1-2 years of experience in clinical operations in pharmaceutical company or CRO including trial set-up, monitoring, and close-out of US and non-US trials at all phases of pre-NDA clinical research (Phases 1-3)., • 1-2 years experience in TMF/document management or clinical trial support., • Experience with eTMF systems (e.g. Trial Interactive eTMF, Veeva Vault)., • Experience with Clinical Trial Master Systems (CTMS) (e.g. Trial Interactive CTMS, Medidata CTMS) preferred., • Demonstrated track record of successfully supporting multiple projects, trials, and priorities., • Experience with managing study vendors (e.g., CRO, IRT/IXRS, central laboratories, eTMF/CTMS) preferred., • Practical knowledge and implementation of ICH-GCP guidelines and US and ex-US regulations., • Ability to work well with global, multi-disciplinary teams., • Must be a self-starter able to thrive in an entrepreneurial, fast paced, and dynamic work environment., • Must be organized with excellent oral and written communication skills., • Strong learning orientation, curiosity, and commitment to science and patients. The anticipated salary range for this position is $122,000 to $137,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price. Along with our casual, collaborative, and fun work and the chance to make your mark in our mission to erase cancer, Erasca offers a comprehensive and competitive benefits package that includes: Paid Time Off, Holiday, and Sick Leave, Medical, Dental and Vision Plans, Short- and Long-Term Disability, Basic and Voluntary Life/AD&D Coverage, Flexible Spending Accounts (FSA, HSA, and Commute), Critical Illness and Accident Coverage, Pet Insurance, Employee Assistance Program, 401(k) Plan with Erasca contribution, and the opportunity to participate in an Employee Stock Purchase Program. Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.

Job DescriptionCompany Description • Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world. Our goal is to leverage our competencies and resources to positively impact human health worldwide. Founded in 2014, our experienced team has secured partnerships with leading global biopharmaceutical companies, generating a broad and late-stage pipeline of innovative drug candidates. Based on our proven track record of success, Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to not only access the Chinese market but also find a long-term strategic partner for global clinical development. Our unique business model builds on our in-licensed assets and innovative partnerships to expand our internal discovery and development capabilities and has created a portfolio of potential best-in-class and/or first-in-class therapies. Zai currently has four products on the market in China Zai Lab was successfully listed on the Nasdaq Stock Market in September 2017 and completed secondary listing on Hong Kong Stock Exchange in September 2020. In 2022, Zai Lab became dual-primary listed on both the Nasdaq and the Hong Kong Stock Exchanges. Since its inception, Zai Lab has expanded significantly with several offices across China. In 2021, Zai Lab established its U.S. Headquarters in Cambridge, Massachusetts. As of January 2022, the Company has a global team of approximately 2000 employees. Job Description Primary Function: The Clinical QC Manager is a Clinical Operations–based role responsible for conducting independent quality control (QC) assessments to confirm that investigational sites are executing clinical trials in accordance with study protocols, GCP, and company procedures. This role performs targeted, risk‑based QC oversight through on‑site QC visits and focused documentation and process reviews to verify that critical study activities are being performed as intended. Working in partnership with Clinical Trial Managers (CTMs), CRAs, and other Clinical Operations staff, the Clinical QC Manager independently assesses site execution and protocol adherence and collaborates with the study team on follow‑up actions. The role identifies protocol adherence gaps, recurring operational issues, and process risks, and supports timely follow‑up with accountable owners. This position does not replace routine monitoring activities or serve as the primary site management function; rather, it strengthens study execution by evaluating site processes, identifying trends, and supporting issue resolution across studies. This position reports to the Executive Director, Head of US Clinical Operations, and is based in our South San Francisco, CA office. Frequent travel to investigational sites is required to support on‑site QC visits and assessments. Major Responsibilities and Duties: QC Planning, Assessments, and Reporting • Develop and maintain study‑specific QC plans, updating based on study progress, complexity, and risk assessment., • Create and maintain QC tools (e.g., checklists, templates, trackers) to support consistent execution of QC activities., • Conduct risk‑based, on‑site QC visits to investigational sites to assess protocol adherence and execution of critical study processes (e.g., informed consent process checks, protocol‑required procedures, safety reporting processes, and essential document maintenance)., • Conduct in‑house QC activities (remote or in‑office reviews) as needed, ensuring QC activities are completed within defined timelines and quality expectations., • Evaluate site processes and documentation to confirm studies are being conducted consistently and as intended., • Prepare clear, objective QC Visit Reports documenting scope, observations, trends, and required follow‑up actions., • Escalate significant compliance, patient safety, or data integrity concerns through defined Clinical Operations escalation pathways. Issue Identification, Follow‑Up, and Trend Analysis • On a regular basis, in partnership with Clinical Operations teams, identify protocol deviations, recurring site‑level issues, and operational risks through QC activities., • Support study teams with root cause analysis (RCA) and contribute to the development of corrective and preventive actions (CAPA), as needed., • Track QC findings and follow‑up actions to closure and contribute to cross‑site and cross‑study trend analysis. Inspection Readiness Support • Support inspection readiness activities across preparation, conduct, and follow‑up phases, including self‑checks and targeted readiness reviews., • Perform targeted reviews of site and study documentation as part of QC assessments to support ongoing inspection readiness., • Provide QC summaries and documentation to Clinical Operations leadership and study teams, as requested. Training, Knowledge Sharing, and Operational Improvement • Contribute to training activities for Clinical Operations teams based on QC findings, common site execution gaps, and protocol adherence challenges., • Incorporate lessons learned from QC activities and regulatory inspections into training, guidance, and study team communications., • Identify opportunities for process improvement based on QC observations and trends., • Support implementation of applicable SOPs and study processes by reinforcing procedural expectations and providing training or clarification on relevant procedures.Qualifications REQUIRED: • Bachelor’s degree in medical science or a related field, with five years’ experience in clinical research, including hands‑on experience with quality‑related activities, such as QC oversight and inspection‑related activities; or equivalent combination of higher education, training and experience. PREFERRED: • Deep knowledge and understanding of clinical trial processes and quality management., • Strong working knowledge of ICH‑GCP as well as applicable regulations and guidelines., • Solid understanding of the skills and knowledge required to deliver a clinical study (e.g., international guidelines, study management, site management, and monitoring)., • Strong communication and influencing skills: able to communicate effectively and concisely, clearly articulate viewpoints, and align with stakeholders., • Demonstrated ability to analyze, interpret, and resolve complex issues., • Ability to think strategically and objectively, demonstrating creativity, innovation, and sound judgment., • Demonstrated commitment to the highest standards of integrity and ethics. Additional Information The pay range for this position at commencement of employment is expected to be between $145K and $170K/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. At Zai, we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels, 58% of our employees are women and 54% of our management positions are held by women. We are committed to the health of patients and our planet. That’s why our environmental protection, social responsibility, and corporate governance strategy, called “Trust for Life” is integrated within our business. Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability. Zai Lab is committed to protecting the privacy and security of the information we collect and to being transparent about the purposes for which we use your information. We have a Privacy Notice which sets forth our policies and practices for handling the information we collect and use in the employment context. Privacy Notice available upon request.

Job Description Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. The Director, Data Systems (DS) and Clinical Programming (CP) will be responsible for leading and managing the Clinical Programming function within Data Management (DM). This position will report to the VP, Data Management and Clinical Programming. Responsibilities: • Lead and manage the Data Systems and Clinical Programming function within DM, • Drive the implementation of various technology solutions to augment existing DM processes, optimize efficiency and enhance overall data quality assurance, • Lead and/or participate in AI-related initiatives for DM, • Develop and implement strategies for optimizing data flow, database builds, and integration of external technologies., • Oversee the validation of the EDC platform, ensuring ongoing system optimization., • Manage relationships with key external vendors, ensuring alignment with organizational goals., • Ensure compliance with all relevant data privacy regulations and maintain the security of clinical trial data., • Ensure DS&CP project deliverables are completed on time and in accordance with quality standards and regulatory requirements., • Collaborate with other departments to align data strategy with broader organizational goals and objectives., • Mentor and develop team members, fostering a culture of continuous learning and growth within the team., • Oversee all SAS clinical programming requests and standardize the clinical programming specification development process., • Develop and/or maintain Alumis' standard CRFs and standard edit checks, inclusive of indication-specific standards., • Develop DS&CP SOPs and Work Instructions., • Lead the development and/or maintenance of standard vendor Data Transfer Agreements (DTAs)., • Oversee the development and execution of technical initiatives within DM, including the implementation of key data visualizations and dashboards for DM, such as Clean Patient Tracking, data currency, and rolling batch freeze progress., • Integrate the usage of data analytics within DM to further optimize current processes., • Provide strategic oversight of high-priority projects, including database builds, user access management, and the release of system updates., • Participate in EDC, IRT and eCOA User Acceptance Testing (UAT), • Ensure accurate development and execution of data integrations between EDC, IXRS or additional external vendor data sources, • Ensure DS&CP study-specific documentation is in an inspection-ready state and represent the DS&CP function in inspections as applicable., • Represent DS&CP in cross-functional meetings as applicable, • Act as a key stakeholder in developing and executing strategies to accelerate drug development through innovative data management practices.Qualifications:, • 12+ years of relevant experience and has earned a BS or equivalent degree; MS or MBA a plus, • Experience supporting Ph I-IV clinical trials, both in-house and through CRO partners, • Strong knowledge and experience in EDC and other key technologies (e.g., IXRS, data visualization), • Proficiency in CDISC standards (CDASH, SDTM, ADaM), • Experience with SAS, SQL and/or other clinical programming tools, • Proficiency in clinical research regulations and guidance, including FDA CFR and ICH GCP, • Depth of experience across all aspects of DM, including but not limited to: CRF and database development, data quality assurance and analytics, data transfer management, vendor management, DM study documentation and inspection readiness., • Strong understanding of the application of MedDRA and WHO Drug clinical data coding classification systems, • Strong interpersonal, organizational, and communication (oral and written) skills, • Demonstrated ability to cultivate strong working relationships with internal and external colleagues., • Logical thinking, attention to detail and accuracy, strong organizational skills, and problem-solving abilities, • Ability to prioritize and to adapt quickly to changing business conditions with a "can-do" attitude, • Capable of proactively identifying project challenges and risks and proposing appropriate and strategic solutions to issues., • Willing to travel if required Alumis Values • We Elevate, • We Challenge, • We Nurture This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. Open to remote applicants with requirement to be onsite 1-2x a quarter. The salary range for this position is $200,000 USD to $225,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices. Alumis Inc. is an equal opportunity employer.

Job DescriptionSalary: $180,000 - $195,000 Job: Associate Director, Clinical Operations (Late-Phase) Location: Thousand Oaks, CA or San Francisco, CA Position type: Full Time Reports to: Senior Director, Clinical Operations Position Summary: Reporting to the Senior Director, Clinical Operations, the Associate Director will be responsible for leading the execution of assigned late-phase clinical trials. This individual will work directly with the cross-functional study team to define and implement the operational strategy for assigned trials, and deliver on milestones within prescribed timelines and budget, and with high quality. The ideal candidate will be experienced in leading Phase 2 and Phase 3 multi-center trials, possess strong verbal and written communication skills, and be able to work effectively and independently in a fast-paced environment. Candidates should be local to Thousand Oaks, CA or the San Francisco Bay area. Responsibilities include (but are not limited to): • Define and implement the operational strategy for assigned clinical trials, in collaboration with the cross-functional team and clinical leadership., • Provide expertise into the development of clinical documents (eg., study protocols and amendments, investigator brochures, case report forms, informed consent forms, study plans, site manuals, etc.). Author portions of clinical documents as required., • Develop and manage trial timelines to ensure alignment with overall program objectives and milestones., • Effectively manage trial communication to ensure stakeholders are informed of and aligned on trial activities and progress., • Proactively identify, communicate, and manage risks that may affect trial milestones, quality, or budget., • Identify and select qualified vendors. Responsible for vendor performance management., • Perform co-monitoring, as required, to support site, vendor and trial oversight., • Ensure clinical studies are conducted in compliance with SOPs, ICH/GCP guidelines, and FDA regulations. Oversee and ensure high quality of clinical trial execution and trial data., • Oversee and direct clinical contractors, as required., • Oversee and ensure accuracy of clinical trial budgets. Oversee accruals reporting and forecasting for assigned trials. Review vendor invoices for accuracy., • Contribute to Clinical Operations resource and budget planning., • Contribute to the development of department SOPs, systems, policies, best practices, and standards that support high quality clinical trial execution and GCP inspection readiness., • May manage direct reports, including ongoing performance management, mentorship, and career development., • Up to 25% travel may be required, consistent with project needs. Minimum Requirements: • Bachelors Degree in life sciences, • 8 years relevant industry experience, • >3 years of experience on acute and/or chronic pain studies., • Proficient knowledge of ICH GCP, CFR, and other applicable regulatory requirements for clinical trial conduct., • Prior experience directing and managing Phase 2 and Phase 3 clinical trials. Prior experience with pain or analgesia trials preferred but not required., • Prior experience with resource, budget, and vendor management., • Demonstrated critical thinking, problem solving, and negotiation skills, • Demonstrated ability to successfully work in cross-functional project teams with an emphasis on teamwork, collaboration, and communication., • Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders (e.g., scientific advisors, clinical consultants, CROs, investigators)., • Self-disciplined, detail-oriented, and able to prioritize tasks to meet critical deadlines.

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Medical Affairs organization provides patients, healthcare providers, and payers everywhere with the practical and clinically relevant information and solutions they need to use AbbVie products safely and effectively, throughout the product lifecycle and the patient’s journey. The Scientific / Medical Director, Medical Affairs provides specialist medical and scientific input into core strategic and operational medical affairs activities for AbbVie’s Oncology portfolio such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives, scientific communications, value propositioning, and safeguarding patient safety (risk minimization activities and safety surveillance activities). The Scientific / Medical Director works closely with commercial and research and development teams to provide critical medical input into evolving core medical, brand (product), and value and access strategies to support our evolving on-market and therapeutic area needs. Responsibilities • In collaboration with Global Medical teams, Clinical Development, Commercial, Market Access, Regulatory, HEOR and other functional areas, provides leadership and support for assigned indications/projects., • Works closely with Brand Teams and relevant cross-functional, area/affiliate medical teams, to provide strategic input into core asset strategy, and is responsible for executing medical support/launch activities for gynecologic oncology initiatives., • Conducts promotional review and assists in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia., • Serves as Medical expert for internal and external stakeholders regarding asset clinical profile, value, and appropriates; and provides Medical review for cross-functional deliverables, ensuring compliance and scientific accuracy., • Develops innovative research concepts, generates evidence, and drives execution of scientific communication plans, including high-quality publications, presentations, and educational programs., • Engages and cultivates relationships with key opinion leaders, scientific advisors, and advocacy groups within the gynecologic oncology community., • Monitors the evolving relevant therapeutic landscape to inform business decisions and anticipate future needs., • Leads the development and execution of advisory boards., • May lead delivery of medical functional plan, brand plan, and/or integrated evidence plan.Qualifications Position will be commensurate with education and experience. For Scientific Director: • Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred., • 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred., • Substantial understanding of relevant therapeutic area required., • Minimum of 4 years of clinical trials direct management experience in the pharmaceutical industry or academia or equivalent. 4+ years of experience is preferred. For Medical Director: • Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D). Relevant therapeutic specialty in an academic or hospital environment preferred. Completion of residency and/or fellowship is preferred., • Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 5 years of experience is preferred. Other • Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols., • Ability to run a clinical study independently with little supervision., • Proven strategic leadership, influencing, and collaboration skills in cross-functional environments. Ability to interact externally and internally to support global business strategy., • Expertise in evidence generation, scientific communication, and health economics/outcomes research., • Must possess excellent presentation, organizational, and written/oral communication skills. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job Description Account Manager – Healthcare AI | SF | $140K–$160K + Equity - 27777753 We're partnering with a fast-growing, Andreessen Horowitz-backed healthcare AI company that is fundamentally reshaping how clinical trials recruit patients — one of the most critical and chronically broken bottlenecks in drug development. With a 92%+ commercial win rate, 7 of the top 15 research site networks already as customers, and organic pipeline growth fueled entirely by word-of-mouth, this company is building something rare: a product their customers genuinely love. They're now looking for their first dedicated Account Manager — someone ready to own the entire post-sale motion and help define what world-class customer success looks like at a company on a hypergrowth trajectory. The Opportunity This is not a role where you inherit someone else's playbook. You'll build it. As the Account Manager, you'll be the primary relationship owner for some of the largest clinical research site networks in the country — working directly with C-suite and VP-level executives — and you'll have full commercial ownership from day one. The company's AI-powered SMS and Voice agents have been battle-tested across 500K+ patient interactions, 190+ sites, and 300+ clinical trials, delivering the highest patient conversion rates on the market. Your job is to make sure customers realize that value — and expand it. What You'll Own • Retention & Expansion across the full customer book, managing relationships with CEOs, COOs, and CROs at leading research site networks, • Quarterly Business Reviews grounded in real performance data — study volume, screen-fail rates, ROI against contract terms, • Revenue Growth through new study onboarding, additional site expansions, and adoption of new AI voice and SMS products, • Contract Negotiations — renewals, amendments, and pricing discussions with senior stakeholders, • Voice of the Customer — synthesizing feedback into structured product input that shapes the roadmap Why This Role Stands Out ✅ Backed by the best — Andreessen Horowitz, Jack Altman, and the Co-Founder of Flatiron Health (the largest pharma tech exit of all time) ✅ Real commercial traction — largest live contract worth $450K+ annually; pipeline growing entirely from customer referrals ✅ Mission that matters — clinical trial delays cost the industry $600K–$8M per day; this company is solving it ✅ High ownership, high impact — you're not a cog in a machine. You're defining how account management works at a company solving a $100B+ industry problem ✅ Exceptional compensation — $140K–$160K base + 0.1–0.3% equity at a Series A company with serious momentum What We're Looking For Experience & Seniority • 2–8 years of B2B account management or post-sale experience, with at least 1–2+ years of direct commercial ownership — including retention and expansion quotas (NRR, GRR, expansion ARR), • Background at a healthcare technology company — think Headway, Tennr, Latent Health, Tandem, AI Growth Therapy, or similar seed-to-Series B health tech startups, • Proven experience selling into or managing SMB healthcare accounts — clinics, research sites, or health systems (not pharma/biotech enterprise), • Track record of managing executive relationships (CEO, COO, VP-level) with a defined book of business and measurable results — be prepared to cite specific dollar amounts retained and expanded, • Experience operating without a pre-built playbook — you've built processes from scratch and thrived in ambiguity Hard Skills • Has personally owned upsell and expansion metrics — NRR, GRR, expansion ARR, • Can speak concretely to dollar amounts retained and expanded in prior roles, • Comfortable leading data-driven business reviews with senior stakeholders Education • Bachelor's degree from a top-25 university preferred — though strong experience will always speak louder than credentials High Agency Profile • Energized by early-stage environments where the structure doesn't yet exist, • You don't wait for a process to be handed to you — you build it, test it, and iterate This Role Is NOT For You If... ???? You've been in a pure CSM or support role without retention/expansion quota ownership ???? Your background is exclusively in large pharma, biotech, or enterprise healthcare (e.g., Regeneron, J&J) — the SMB motion here is fundamentally different ???? You've never had direct commercial accountability for a book of business Compensation & Details ???? Base Salary $140,000 – $160,000 ???? Equity 0.1% – 0.3% ???? Location San Francisco, CA (on-site, 5 days/week) ???? Education Top-25 university preferred; not required ???? Team Size ~8 people ???? Stage Seed / Series A, $4.3M raised Ready to Apply? If you're an account manager with a healthcare tech background who thrives in high-ownership environments and wants to be part of something genuinely transformative, we want to hear from you. ???? Send your resume to: cube10@cubemanagement.com Please include a brief note on your healthcare technology experience, the book of business you've managed, and specific retention/expansion metrics you've owned. Qualified candidates will be contacted promptly. This search is being conducted by Cube Management on behalf of our client. The company name will be shared with shortlisted candidates.

Job DescriptionCompany Description Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world. Our goal is to leverage our competencies and resources to positively impact human health worldwide. Founded in 2014, our experienced team has secured partnerships with leading global biopharmaceutical companies, generating a broad and late-stage pipeline of innovative drug candidates. Based on our proven track record of success, Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to not only access the Chinese market but also find a long-term strategic partner for global clinical development. Our unique business model builds on our in-licensed assets and innovative partnerships to expand our internal discovery and development capabilities and has created a portfolio of potential best-in-class and/or first-in-class therapies. Zai currently has four products on the market in China Zai Lab was successfully listed on the Nasdaq Stock Market in September 2017 and completed secondary listing on Hong Kong Stock Exchange in September 2020. In 2022, Zai Lab became dual-primary listed on both the Nasdaq and the Hong Kong Stock Exchanges. Since its inception, Zai Lab has expanded significantly with several offices across China. In 2021, Zai Lab established its U.S. Headquarters in Cambridge, Massachusetts. As of January 2022, the Company has a global team of approximately 2000 employees. Job Description The Senior Clinical Trial Manager will lead, manage and co-ordinate the operational strategy, risk management, and overall execution of clinical trials from study start-up to close out at a global level in accordance with ICH-GCP and applicable local regulations. Collaborate with cross functional stakeholders to ensure deliverables are met in terms of quality, compliance, budget, and timing. This role may work collaboratively on one trial or across several trials to support clinical operations activities. This position is based in our South San Francisco, CA office. • Lead and coordinate a cross-functional study team to ensure the clinical trial progresses as planned., • Accountable for the overall operational strategy and delivery (e.g., country and site selection/start-up, site contracts, patient recruitment and retention, etc.) of assigned clinical trials; ensuring that study-level deliverables are met according to timeline, budget, and quality requirements., • Participates in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central/specialty lab, ECG, imaging, PRO specifications, drug supply, biomarker/sample management plans, TMF, and CSRs., • Drafts and implements study plans including; vendor oversight, risk, quality, safety, communication, trial monitoring, and TMF., • Ensures TMF creation and QC completion., • Supports EDC, IxRS, and CTMS systems and data maintenance., • Tracks budget, timelines, milestones, and critical study activities, identifies issues and proposes potential resolutions., • Accountable for the study budget and manages assigned vendor budget(s); communicates variances in actual versus forecasted spend in vendor budgets and presents an action plan for resolution., • Drives the selection of vendors (participates in the Request for Proposal (RFP) process) on a global scale., • Oversees delegated outsourced activities to ensure CRO and vendor delivery against the contracted scope of work., • Leads the Investigator Meeting preparation and execution with the support from cross-functional team members, • Stays current on relevant therapeutic area knowledge and clinical research best practices., • Ensures study adherence to ICH/GCP and company SOPs.Qualifications REQUIRED: • Undergraduate degree in a scientific or health-related discipline., • Minimum of 8 years relevant experience of which 5 years are clinical experience in the pharmaceutical industry, including 3 years in study management or equivalent combination of education, training, and experience., • Ability to work across several time zones. PREFERRED: • Prior people management experience., • Demonstrated ability in clinical study management processes and clinical/drug development., • Highly effective verbal and written communication skills; effectively deliver key messages; aptitude to independently communicate with teams and stakeholders., • Ability to effectively lead projects and persuade and influence peers; ability to build trusting and collaborative relationships globally., • Experience with effective vendor management., • Strong customer focus with investigators, functional peers, vendors, etc., • Excellent planning and organizational skills., • Working knowledge of international regulatory and ICH Good Clinical Practice guidelines., • Maintains the highest standards of integrity and ethics. Additional Information The pay range for this position at commencement of employment is expected to be between $177K and $229K/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. At Zai, we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels, 58% of our employees are women and 54% of our management positions are held by women. We are committed to the health of patients and our planet. That’s why our environmental protection, social responsibility, and corporate governance strategy, called “Trust for Life” is integrated within our business. Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability. Zai Lab is committed to protecting the privacy and security of the information we collect and to being transparent about the purposes for which we use your information. We have a Privacy Notice which sets forth our policies and practices for handling the information we collect and use in the employment context. Privacy Notice available upon request.

Job DescriptionMedical Science Liaison (MSL), Oncology (Skin Cancers)Territory: Central and Western United StatesRole Overview The MSL, Oncology (Skin Cancers) will join a fast-growing Field Medical Affairs team focused on commercializing the novel Signatera™ molecular residual disease (MRD) test. This role is dedicated to supporting oncologists and cancer researchers across solid tumors—with a primary emphasis on skin cancers—alongside complementary products and services within Natera's oncology portfolio. In 2019, the FDA designated Signatera as a Breakthrough Device, and Medicare proposed coverage for its use in patients with Stage II–III colorectal cancer as its first indication. We are seeking a smart, mission-oriented Medical Affairs professional who can communicate effectively to help transform the management of cancer worldwide. The MSL serves as a vital field-based scientific resource for clinicians, academic institutions, and professional organizations. Primary Responsibilities Scientific Presentation: Deliver high-impact scientific and clinical presentations on Natera's oncology products, specifically relevant to skin cancers. Information Support: Address the specific needs of customers by responding to requests for information about marketed and developing products across solid tumors. Internal Collaboration: Serve as a medical and scientific resource for Natera Sales and Marketing teams, including participation in scientific updates and training with an emphasis on skin cancer data. KOL Engagement: Identify, develop, and manage collaborative working relationships with Key Opinion Leaders (KOLs) in oncology, including dermatologists, surgeons, and medical oncology specialists. Research & Trials: Develop research collaborations with leading KOLs; assist with registry study enrollment and the management of Investigator-Initiated Trials (IITs) in solid tumors and skin cancer. Content Development: Review and develop educational materials and slide content for healthcare providers and patients—incorporating tumor-type–specific scientific context—subject to approval by Medical Affairs and Marketing. Events & Symposia: Assist in agenda planning and facilitation for Clinical Advisory Boards and Symposia involving cutaneous oncology experts. Compliance: Work regularly with Protected Health Information (PHI) in both paper and electronic forms, utilizing secure technologies to perform responsibilities. Qualifications Advanced Degree: Health care professionals with relevant clinical sciences knowledge in oncology (e.g., Pharm.D, Ph.D., M.D., or DNP). Professional Experience: Prior MSL experience is highly preferred. Specialization: Prior involvement with cutaneous oncology or clinical laboratory tests (molecular diagnostics) is preferred. Knowledge, Skills, and Abilities Communication: Independent thinker and persuasive communicator with an outgoing and confident demeanor. Relationship Building: Proven experience establishing strong, collaborative working relationships with internal stakeholders (Sales, Marketing, Regulatory, R&D) and external oncology customers. Presentation Skills: Outstanding oral presentation skills, particularly when conveying complex scientific concepts related to solid tumors. Autonomy: Ability to work independently and remotely while maintaining a strong teamwork ethic. Scientific Acumen: Strong knowledge of molecular biology and clinical oncology; familiarity with the cutaneous cancer treatment landscape is a significant plus. The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.Remote USA$150,000—$170,000 USD OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.natera.com. Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: https://www.natera.com/notice-of-data-collection-california-residents/ Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information: • BBB announcement on job scams, • FBI Cyber Crime resource page

Job DescriptionCompany Description Zai Lab is a patient-focused, innovative, commercial-stage, global biopharmaceutical company based in China and the United States. We are dedicated to discovering, developing, and commercializing best-in-class and first-in-class therapies that address medical conditions with significant unmet needs in oncology, immunology, neuroscience, and infectious disease. Guided by innovation and driven by purpose, our mission is to leverage our expertise and resources to make a lasting, positive impact on human health worldwide. Zai Lab’s global team of 2,100 talented professionals includes industry leaders and professionals dedicated to advancing novel therapies to patients. With headquarters in Cambridge, Massachusetts, and Shanghai, and teams in the U.S., China and Europe, we collaborate across time zones to deliver meaningful impact where it’s needed most. Founded in 2014 by Dr. Samantha Du, Zai Lab was purpose-built to become a leading global biopharma, combining scientific innovation, operational scale, and strong execution. Our global pipeline features ZL-1310, a DLL3 antibody-drug conjugate (ADC) with best-in-class and first-in-class potential in small cell lung cancer, now in clinical trials. At the same time, our R&D team is progressing several other global programs into the clinic, including ZL-1503, a bispecific IL-13/IL-31 antibody for atopic dermatitis, and ZL-6201, an LRRC15 ADC for solid tumors. In China, we’ve earned a reputation as a partner of choice for leading global biopharmaceutical companies, leveraging our proven commercial infrastructure and clinical trial capabilities to accelerate market access to our innovative products. Due to its large population, China is the second largest pharmaceutical market in the world. Our unique business model combines in-licensed assets with strategic partnerships, leveraging our in-house research capabilities to build a regional portfolio of late-stage, potential best-in-class and first-in-class therapies. Today, with eight products on the market in China, we are delivering meaningful impact for patients and building opportunities for talented professionals to shape the future of medicine. Zai Lab is publicly traded with dual-primary listings on both the Nasdaq Stock Market and the Hong Kong Stock Exchange, underscoring our commitment to transparency, global reach, and long-term growth. Job Description The Clinical Trial Manager will lead, manage, and coordinate the operational delivery, risk management, and overall execution of clinical trials from study start-up to close out at a regional or global level in accordance with ICH-GCP and applicable local regulations. This role will collaborate with cross-functional stakeholders to ensure deliverables are met in terms of quality, compliance, budget, and timing. This role may work collaboratively on one trial or across several trials to support clinical operations activities. This role is based in our South San Francisco, CA office. • Lead and coordinate a cross-functional study team (regional or global) to ensure the clinical trial progresses as planned., • Accountable for the overall operational delivery (e.g., country and site selection/start-up, site contracts, patient recruitment and retention, etc.) of assigned clinical trials or regions; ensuring that study-level deliverables are met according to timeline, budget, and quality requirements., • Participates in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central/specialty lab, ECG, imaging, PRO specifications, drug supply, biomarker/sample management plans, TMF, and CSRs., • Drafts and implements study plans including vendor oversight, risk, quality, safety, communication, trial monitoring, and TMF., • Ensures TMF creation and QC completion., • Supports EDC, IxRS, and CTMS systems and data maintenance., • Tracks budget, timelines, milestones, and critical study activities, identifies issues and proposes potential resolutions., • Provides input to the study budget and manages assigned vendor budget(s); communicates variances in actual versus forecasted spend in vendor budgets and presents an action plan for resolution., • Participates in the selection of vendors (participates in the Request for Proposal (RFP) process) on a global scale., • Oversees delegated outsourced activities to ensure CRO and vendor delivery against the contracted scope of work., • Leads the Investigator Meeting preparation and execution with the support from cross-functional team members, • Stays current on relevant therapeutic area knowledge and clinical research best practices., • Ensures study adherence to ICH/GCP and company SOPs.Qualifications REQUIRED: • Undergraduate degree in a scientific or health-related discipline with 5 years relevant experience of which 3 years are clinical experience in the pharmaceutical industry. PREFERRED: • One year of study management experience., • Demonstrated ability in clinical study management processes and clinical/drug development., • Highly effective verbal and written communication skills; effectively deliver key messages; aptitude to independently communicate with teams and stakeholders., • Experience with effective vendor management., • Strong customer focus with investigators, functional peers, vendors, etc., • Excellent planning and organizational skills., • Working knowledge of international regulatory and ICH Good Clinical Practice guidelines., • Ability to build trusting and collaborative relationships globally., • Willingness to travel domestically and internationally and work across cultures. Additional Information The pay range for this position at commencement of employment is expected to be between $145K and $170K/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. At Zai Lab, we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels, 59% of our employees are women and 53% of our management positions are held by women. We are committed to the health of patients and our planet. That’s why our environmental protection, social responsibility, and corporate governance strategy, called “Trust for Life,” is integrated within our business. Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability. Zai Lab is committed to protecting the privacy and security of the information we collect and to being transparent about the purposes for which we use your information. We have a Privacy Notice which sets forth our policies and practices for handling the information we collect and use in the employment context. Privacy Notice available upon request.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position We are seeking an experienced cardiometabolic Medical Science Liaison (MSL) to join an exciting opportunity within our Medical Affairs (MA) team and work in a dynamic and collaborative environment. This is a field-based position and the candidate must be located within one of the territories . MSLs are responsible for developing professional relationships with healthcare professionals through scientific engagement to support clinical stage and launch molecules. MSLs engage healthcare professionals through scientific exchange and provide clinical and scientific support. Responsibilities • Engage with cardiologists / endocrinologists / healthcare professionals / stakeholders to educate on clinical and scientific evidence to advance treatment landscape as aligned with strategic imperatives., • Educate on RNAi technology, hypertriglyceridemia, familial chylomicronemia syndrome, and hypercholesterolemia., • Synthesize and communicate clinical and scientific insights to internal stakeholders., • Attend and present at scientific congresses and meetings to stay up to date with the latest scientific developments and trends in cardiometabolic therapeutic area., • Respond to unsolicited inquiries consistent with MSL compliance standards., • Support company sponsored clinical trials through investigator site engagement., • Support speaker training as requested and ensure speakers are up to date with evolving disease and product data., • Support national, regional, and local scientific congresses including Opinion Leader (OL) engagement, session coverage, booth, and company debriefs., • Monitor and analyze scientific publications, clinical trials, and competitive landscape in the cardiometabolic therapeutic area., • Maintain clinical and scientific expertise and general industry business acumen., • Advance MSL value proposition, demonstrate tact and professionalism, and deliver results., • Act in accordance with company policies, • Develop territory specific OL and account plans including OL profiles, pre-call planning, and follow up plans., • Communicate clinical and scientific information in an accurate and clear manner., • Document MSL quantitative and qualitative accomplishments., • Provide scientific support for Med Info inquiries, ensuring accurate and timely responses to healthcare professionals' queries., • Develop scientific content for medical education initiatives., • Support Medical Affairs as needed with special projects and initiatives., • Sophisticated cross-functional relationship management is critical for success. Requirements • PhD, PharmD, MD, or DO degree required, • 5 years of experience as an MSL, • Cardiometabolic therapeutic experience, • Industry experience in Medical Affairs at a biotech or pharma, • High level verbal and written communication skills., • Ability to effectively collaborate in a dynamic environment., • Strong comprehension of cardiometabolic therapeutic area., • Ability to interpret key scientific data and translate the findings to meet educational and research needs to affect corporate research strategic activities/decisions., • Ability to identify the unmet medical, educational, and research needs at a local & regional level in the medical community., • An understanding of the health care delivery system, including the managed care arena and its impact on patient care, regional medical care and the pharmaceutical industry., • Understanding of the design and execution of research studies and strategic implications., • Proven ability to drive results at a high level of quality as a strategic and creative thinker., • Demonstrates ability to deal with ambiguity and thrive in an ever-changing environment., • Strong project management skills with demonstrated ability to manage projects and/or colleagues in successful implementation of business-critical projects., • Strong time management & organizational skills., • Ability to travel.Pay Range $190,000—$210,000 USD Arrowhead provides competitive salaries and an excellent benefit package. Candidates must have current, valid authorization to work in the country where this role is located. California Applicant Privacy Policy

Job Description:\n\nCompany Description At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us! Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA. Job Description The Infectious Diseases / Antimicrobial Resistance Medical Science Liaison/Senior Medical Science Liaison functions as a highly trained, field-based, medical affairs scientific expert in the area of Multi-Drug resistant Gram-negative pathogens. Our client is entering the U.S. market with a novel antibiotic targeting multi-drug-resistant Gram-negative pathogens, addressing a critical and growing global health crisis. The MSL/ SR MSL reports to the National Director MSLs. The Medical Science Liaison (MSL) will serve as a strategic scientific partner and field-based clinical expert, responsible for driving scientific engagement, medical strategy execution, and appropriate clinical Information across hospitals and health systems. Unlike traditional MSL roles, this position requires deep expertise in: • Antimicrobial resistance (AMR) • Hospital-based care pathways • Antimicrobial stewardship integration The MSL will operate at the intersection of science, public health, and health system decision-making, ensuring that our client's therapies are used appropriately, timely, and effectively. Following regulatory and corporate guidelines, they will facilitate and build scientific relationships and collaborations with the INFECTIOUS DISEASE scientific community. This position interacts with local, regional, and national Key Opinion Leaders (KOLs) and health care practitioners (HCPs), as well as professional societies and organizations. The Antimicrobial/Infectious Disease MSL will need to be fully engaged with Infectious Disease Professional Societies, as well as other value-based institutions and associations including clinics and centers that are involved with the management and treatment of infections which result from multi-drug resistant gram-negative pathogens. ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:Function as the primary point of contact in the field for Medical Deployment.Maintain clinical, scientific, and technical expertise in Infectious Diseases / Antimicrobial Resistance, with specific focus in Multi-Drug-Resistant Gram-Negative Pathogen infections standards of care.Have a thorough understanding of the clinical protocols and related proceduresDevelop and track key opinion leader (KOL) engagement plans - identify, develop, and maintain long-term collaborative relationships with KOLs within assigned region.Scientific Exchange & Thought Leader Engagement:Establish and maintain peer-to-peer scientific relationships with:Infectious Disease physiciansIntensivistsID pharmacists & microbiologistsAntimicrobial Stewardship Committees (ASC)Serve as a trusted scientific resource, ensuring accurate interpretation of data and deliver balanced, evidence-based scientific exchange on:Clinical trial dataResistance mechanismsNovel mechanisms of actionPatient selection and treatment pathwaysSupport and lead medical & scientific exchange with the medical/scientific community including advisory boards, scientific exchange programs and Congress engagement.Responsible for ongoing territory management and development, including KOL tracking.KOL Strategy & Network Development:Identify, map, and engage national, regional, and institutional KOLsBuild relationships across Academic medical centers, Integrated Delivery Networks (IDNs) and Community hospital systemsAntimicrobial Stewardship & Health System IntegrationEngage directly with:Antimicrobial Stewardship Programs (ASP)Pharmacy & Therapeutics (P&T) CommitteesSupport development of:Clinical pathwaysAntibiotic treatment protocolsInstitutional guidelinesPrecision Antibiotic Stewardship informed by rapid diagnostic testingProvide expertise on:Optimal antibiotic selection, dosing, and durationResistance mitigation strategiesAppropriate patient targetingResponsible for all clinical program requests and for unsolicited requests for information.May collaborate with R&D Team to support sites and investigators participating in the company-sponsored clinical trials.Conduct pre-launch KOL profiling efforts to enhance depth of product/disease/scientific knowledge. Facilitate top account/institution profiling efforts to enhance understanding of patient care pathways, including treatment protocol development.Launch Excellence & Market Shaping:Support pre-launch and launch activities, including:Scientific education programsDisease state awareness initiativesInform appropriate clinical positioning within hospital systems and relevant physicians and stakeholdersPartner cross-functionally to ensure aligned, compliant launch executionWork collaboratively and compliantly with commercial colleagues to assure product strategic imperatives are represented cross functionally in account engagement,Insights Generation & Strategic Impact:Collect, analyze, and communicate field-based insights, including:Local resistance patternsDiagnostic and treatment gapsBarriers to adoptionProvide actionable intelligence to:Medical strategyClinical developmentMarket accessRespond to and document unsolicited requests for information on clinical initiatives.Be solidly versed in the clinical data such that the full range of innovative science, clinical, outcome, economic and value aspects of the Company’s products can be appreciated by the healthcare practitioner, formulary member or payerResearch & Evidence Generation:Identify and support:Investigator-initiated trials (IITs)Real-world evidence (RWE) studiesOutcomes research initiativesCollaborate with clinical teams on:Trial site identificationInvestigator engagementDiagnostics & Innovation Integration (Advanced Capability:)Partner with healthcare systems to understand:Rapid diagnosticsMicrobiology lab workflowsTimeliness of accurate antibiotic selectionSupport strategies linking:Diagnostics → targeted antibiotic use → improved outcomesCross-Functional Collaboration & Internal Leadership:Provide medical support, clinical input, and/or training to internal teams as requested.Serve as the scientific interface between:Medical AffairsMarket AccessCommercial (within compliance boundaries)Provide: Internal training and scientific support for strategic initiativesOperate effectively in a matrixed environmentRepresent the Company at medical meetings through Medical Affairs’ Scientific Booth coverage and other related activities.Attend congresses as appropriate and develop meaningful internal reports of the congresses covered.Adhere to corporate SOPs and ensure vigilant compliance with relevant legal and regulatory guidelines governing scientific interactions with physicians and healthcare professionals across all activities, including those related to clinical trials, scientific interactions with internal and external groups, and responses to unsolicited requests for medical/scientific information.Consistently demonstrate a high standard of excellence in the management of assigned territory while also contributing to the success of colleagues and the MSL team.Willingness to contribute to the achievement of organizational goals beyond the borders of a geographic territory.Qualifications MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.Advanced, terminal degree required (e.g. Pharm.D., Ph.D., M.D.) or equivalent.3–8+ years in Medical Affairs / MSL role preferredMSL: A minimum of 3 years previous MSL experience necessary with a minimum of 1 year in Infectious Diseases / Antimicrobial Resistance.Sr. MSL: A minimum of 5 years of Pharma experience and 3 years of Infectious Diseases / Antimicrobial Resistance experience. History of successful experience shaping scientific narrative and engaging in higher-order dialogue (e.g., data interpretation, evidence gaps, evolving standards of care) Often handles the most complex or sensitive scientific engagements, representing the field on global medical teams indication working groups, advisory planning committees.Infectious Diseases / Antimicrobial Resistance experience strongly preferred for both positions.Strong expertise in:Infectious diseasesHospital-based therapeuticsCritical care / microbiology (preferred)Prior product launch experience highly preferredExperience with Hospital / IDN engagement, antimicrobial stewardship programsExhibits the highest level of scientific, business, and clinical acumen with excellent communication and networking skills.The ability to interpret and present scientific data to engage KOLsDeep understanding of:Antimicrobial resistance (AMR)Gram-negative pathogensHospital treatment pathwaysAbility to:Interpret and communicate complex clinical dataBuild credibility with high-level clinical stakeholdersIncrease scientific share of influence without authority in complex systemsExcellent written and oral presentation skillsAbility to travel frequently (50-70%) with overnight stays (e.g., KOL meetings, site locations, internal meetings, medical meetings and congresses, training).Additional Information OUR CULTURAL BELIEFS Patient Minded I act with the patient’s best interest in mind. Client Delight I own every client experience and its impact on results. Take Action I am empowered and hold myself accountable. Embrace Diversity I create an environment of awareness and respect. Grow Talent I own my development and invest in the development of others. Win Together I passionately connect with anyone, anywhere, anytime to achieve results. Communication Matters I speak up to create transparent, thoughtful, and timely dialogue. Always Innovate I am bold and creative in everything I do. Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA. EVERSANA is committed to providing competitive salaries and benefits for all employees. If this job posting includes a base salary range, it represents the low and high end of the salary range for this position and is not applicable to locations outside of the U.S. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). More information about EVERSANA’s benefits package can be found at eversana.com/careers. EVERSANA reserves the right to modify this base salary range and benefits at any time. From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at applicantsupport@eversana.com. Follow us on LinkedIn | Twitter

Job Description We are seeking a board-certified or board-eligible Psychiatrist with expertise or strong interest in Interventional Psychiatry and Neuropsychiatry to join our growing clinical team. This physician will lead and deliver evidence-based treatments for patients with complex, treatment-resistant mood and neuropsychiatric disorders, with a focus on interventional modalities including TMS and Spravato. The role combines direct patient care, procedural excellence, collaboration with advanced practice providers, and participation in clinical program development to ensure high-quality, measurable outcomes across the organization. Key Responsibilities: Clinical Care Evaluate and diagnose patients with treatment-resistant depression, bipolar disorder, OCD, PTSD, and other complex neuropsychiatric conditions. Develop comprehensive treatment plans incorporating interventional modalities. Deliver and/or supervise: Transcranial Magnetic Stimulation (TMS) SAINT Esketamine (Spravato) and/or IV ketamine administration Other therapies as program expands and novel treatments are approved Monitor clinical outcomes and adjust treatment protocols accordingly. Provide ongoing psychiatric medication management as clinically indicated. Program & Quality Leadership Partner with Clinical Operations and Medical Leadership to build and scale interventional and neuropsychiatric services. Contribute to protocol development, SOP refinement, and standardization of care. Ensure regulatory compliance and safety standards for procedural services. Participate in quality review, outcomes tracking, and performance improvement initiatives. Contribute to a culture of scholarship that promotes the incorporation of new evidence and the generation of scholarly work (e.g., publication of case reports). Collaboration & Supervision Collaborate closely with advanced practice providers, therapists, and other clinical staff. Provide physician oversight and consultation to advanced practice providers as needed. Participate in case conferences and interdisciplinary treatment planning. Innovation & Research Integration Support the successful deployment and implementation of the Advanced Trial for Longitudinal Assessment in Salma (ATLAS) in the clinic. Serve as site PI or study physician for industry sponsored trials. Required Qualifications: MD or DO degree from an accredited institution. Board Certified or Board Eligible in Psychiatry. Active, unrestricted medical license in California (or application in process to obtain one). DEA registration. Preferred Qualifications: Experience or formal training in TMS and/or ketamine-based therapies preferred. Experience working with treatment-resistant populations is strongly preferred. Comfort working in a growth-oriented, performance-driven clinical environment. Compensation & Benefits: Total compensation up to $350,000, depending on experience and qualifications We offer a benefits package including medical, dental, and vision coverage, a 401(k) retirement plan, PTO, and additional benefits. We reserve the right to modify benefit offerings at any time, in accordance with applicable laws. Equal Opportunity & Accessibility Statement We are committed to providing a workplace that is inclusive, respectful, and free from discrimination. We welcome applicants of all backgrounds and make employment decisions without regard to race, color, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, ancestry, citizenship, age, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, or any other characteristic protected by California or federal law. In accordance with the California Fair Chance Act, we will consider qualified applicants with arrest and conviction records. If you require a reasonable accommodation during the application or hiring process, please contact us directly - we’re happy to help.

Job DescriptionThe Opportunity At Maze Therapeutics, we believe that precision medicine has the power to transform the lives of patients with both common and rare diseases. As a Clinical Trial Manager (CTM) at Maze Therapeutics, you'll play a hands-on role in co-leading and driving the execution of our Chronic Kidney Disease (CKD) clinical trials. You'll have the opportunity to contribute to mid to late-stage clinical studies, work cross-functionally with internal teams and external partners, and ensure trials run efficiently and with the highest quality standards. If you enjoy rolling up your sleeves, collaborating across teams, and bringing innovative medicines to patients, this role could be the perfect fit for you. The Impact You'll Have • Steer the execution of one or more of our Phase 2 CKD clinical trials; from protocol development to achievement of corporate and study milestones such as first patient in, interim analysis, database lock, and study report completion., • Manage external vendors including CROs, additional key vendors, and global investigative sites., • Ensure adherence to study protocols, SOPs, ICH GCP guidelines by overseeing monitoring activities at investigative sites., • Coordinate the development of study materials such as CRFs, ICFs, patient diaries., • Act as the voice of Clinical Operations on cross-functional teams, including the Study Execution Team (SET)., • Partner with Clinical Operations and Clinical Science Team to engage with therapeutic area KOLs and Investigators. What We're Looking For, • A degree in a scientific discipline or health related field., • Minimum of 4 years clinical research experience, including 2 years as a Clinical Trial Manager at a biopharmaceutical company or CRO., • Experience with planning and executing Phase I-II trials is preferred., • Demonstrated proficiency in implementing, monitoring, and management of clinical trials, from start-up to close-out., • General knowledge of FDA regulatory requirements and ICH GCP guidelines., • Strong organizational skills, ability to prioritize and multi-task., • Excellent verbal and written communication skills., • Demonstrated problem-solving and negotiation abilities., • Ability to work as part of a team and build strong working relationships with internal and external partners., • Capacity to roll-up sleeves to perform a broad range of clinical trial related tasks as needed., • Willingness to travel as necessary, consistent with project needs., • Excellent computer proficiency (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook)., • Experience with clinical trial databases (e.g., Medidata Rave, Veeva, etc.). About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company's pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease. Maze is based in South San Francisco. Our People Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients. Our Core Values Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we'll achieve our mission. Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others. Stand True – Our integrity is foundational; it guides us no matter the obstacle. The expected annual salary range for employees located in the San Francisco Bay Area is $143,000 - $175,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future. Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy. #LI-Hybrid

Job Description About the Role The Head of Technology Development is a senior technical leader responsible for defining and executing the end‑to‑end technology strategy for Vivani’s device and drug–device combination product portfolio. This role drives innovation, leads cross-functional development programs, and ensures that products meet the highest standards of safety, performance, and regulatory compliance from concept through commercial launch. You will oversee internal and external development partners, manage design control and technology transfer, and collaborate closely with Operations, Quality, Regulatory, and Clinical teams to ensure timely and successful program execution. Key Responsibilities Technology & Product Development Leadership • Provide strategic leadership for all technology development activities across multiple device and combination product programs., • Own the technology roadmap and ensure alignment with company goals, clinical needs, and commercial scalability., • Lead product development from concept feasibility through design, verification, validation, clinical support, and commercialization., • Serve as the technical authority and decision-maker for device architecture, materials, processes, and risk mitigation. Design Control & Regulatory Compliance • Ensure full adherence to design control processes, including requirements development, specifications, verification/validation planning, and design transfer., • Oversee creation and approval of documentation such as design history files, technical reports, validation summaries, and risk management files., • Partner with Regulatory Affairs to support submissions and ensure compliance with FDA, cGMP, ISO, and global regulatory expectations. Cross-Functional Collaboration • Collaborate closely with Operations to identify and deploy technologies that improve manufacturability, reduce cost, and enhance yield and process capability., • Work with Clinical and Quality teams to ensure product readiness for clinical trials and post‑market requirements., • Communicate program status, risks, and mitigations clearly to executives and stakeholders. External Partner, Vendor & CMO Management • Lead the selection, onboarding, and management of technology partners, development firms, and contract manufacturing organizations (CMOs)., • Ensure external teams deliver high-quality work that aligns with program milestones, budgets, and compliance expectations., • Establish and maintain strong technical oversight, review processes, and performance metrics. Risk Management & Continuous Improvement • Identify critical process parameters and create robust control strategies to ensure safety, performance, and manufacturability., • Promote best practices in engineering, quality, and program management across the organization., • Drive continuous improvement initiatives to strengthen design robustness, reduce variability, and accelerate development timelines. Requirements • Ph.D. (or equivalent) in Engineering, Life Sciences, Materials Science, or a related field., • 15+ years of experience in the medical device or biotech industry, including at least 5 years in a pre-commercial or early-stage company., • Demonstrated leadership in developing Class III implantable devices and/or drug–device combination products., • Deep understanding of cGMP, FDA regulations, ISO standards, and global regulatory frameworks., • Proven experience managing design control, product development processes, and technology transfer., • Strong track record of leading cross-functional teams and managing complex, multi-stakeholder programs., • Exceptional communication, organizational, and problem‑solving skills., • Experience overseeing CMOs and external development partners., • Experience advanced materials, drug delivery systems, and implantable devices., • Experience scaling products from prototype to commercial manufacturing Salary Range: $195,000 - $250,000 Final compensation will be determined on job-related factors such as experience, education, and training. Benefits • Medical, • Dental and Vision, • Flexible Spending Account (FSA), • 401K with Company Safe Harbor Match: 100% /up to 4%, • Life Insurance, • Long Term Disability, • Home Office Stipend, • Commuter benefits

Job Description OPPORTUNITY Mammoth Biosciences seeks an experienced Senior Clinical Scientist to advance pre-clinical research into clinical trials. This role encompasses both tactical and strategic responsibilities, including the design and execution of clinical trials, as well as meticulous monitoring of data for accuracy and integrity to ensure regulatory compliance. The incumbent will collaborate closely with the medical monitor, operations team, CRO partner, and study sites to ensure an efficient recruitment and follow-up of subjects in accordance with study protocols. Reporting to the VP, Clinical Development, the Senior Clinical Scientist will be responsible for the compilation and analysis of study data for various internal and external reports, as well as for key meetings. KEY RESPONSIBILITIES Trial Design and Execution: participate in protocol development, develop study CRFs, ICFs and databases Data Analyses and Monitoring: monitor clinical trial data for accuracy and integrity Compliance: ensure all study activities adhere to regulatory and ethical guidelines Collaboration: act as a bridge between medical monitor, operations, CRO and study sites to ensure efficient communications, subject recruitment and trial management Reports: write study reports, plans, and make data presentations for internal and external meetings Other duties as assigned REQUIRED QUALIFICATIONS Master’s degree/PharmD/PhD in a relevant life science field Minimum of 5 years experience in the pharmaceutical or biotechnology industry, with at least 2 years experience in clinical science/clinical development Demonstrated experience in the design, execution, and reporting of global Phase 1-3 clinical trials Strong proficiency in data analysis, interpretation of clinical trial results, and presenting data Deep knowledge of Good Clinical Practice (GCP), ICH guidelines, and global regulatory requirements for clinical trials (FDA, EMA, etc.) Excellent verbal, written, and presentation skills with proven ability to communicate with multiple stakeholders Ability to travel internationally for site visits as needed PREFERRED QUALIFICATIONS Experience managing or directly overseeing clinical monitoring and data management processes Prior experience in a clinical scientist role within a high-growth, fast-paced biotechnology environment Demonstrated success in leading cross-functional teams and managing external partners (CROs) Strong collaborator with strategic planning and independent problem-solving skills Experienced in patient safety guidelines Knowledgeable about clinical trial ethics and regulatory standards Strong follow-up skills Ability to manage multiple conflicting priorities BENEFITS Company-paid health/vision/dental benefits Unlimited vacation and generous sick time Company-sponsored meals and snacks Wellness, caregiver and ergonomics benefits 401(k) with company matching Actual base salary will be determined by relevant professional experience, applicable skills, and internal equity. COMPANY Mammoth Biosciences is a biotechnology company focused on leveraging its proprietary ultracompact CRISPR systems to develop long-term curative therapies, as well as other applications such as decentralized precision diagnostics. Founded by CRISPR pioneer and Nobel laureate Jennifer Doudna and Trevor Martin, Janice Chen, and Lucas Harrington, the company’s ultracompact proteins are designed to enable in vivo gene editing in difficult to reach tissues utilizing both nuclease applications and new editing modalities beyond double stranded breaks, including base editing, gene writing, and epigenetic editing. The company is building out its pipeline of potential in vivo gene editing therapeutics and capabilities and has partnerships with leading pharmaceutical and biotechnology companies to broaden the reach of its innovative and proprietary technology. Mammoth’s deep science and industry experience, along with a robust and differentiated intellectual property portfolio, have enabled the company to further its mission to transform the lives of patients and deliver on the full promise of CRISPR technologies. It is our policy and intent to provide equal opportunity to all persons without regard to race, color, religion, political affiliation, sex/gender (including gender expression/identity, pregnancy, childbirth and related medical conditions), marital status, registered domestic partner status, sexual orientation, age, ancestry, national origin, veteran status, disability, medical condition, genetic characteristics, and/or any other basis protected by law. This policy covers all facets of employment including, but not limited to: recruitment, selection, placement, promotions, transfers, demotions, terminations, training, and compensation. Mammoth Biosciences requires that all employees be vaccinated against COVID as a condition of at-will employment, with exceptions for medical or religious reasons in compliance with local, state, and federal law. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job DescriptionThe Position At Maze Therapeutics, we believe that precision medicine has the power to transform the lives of patients with both common and rare diseases. As a Senior Clinical Trial Specialist (Sr. CTS) at Maze Therapeutics, you'll play a key role in supporting our Clinical Operations team as we deliver an exciting clinical trial in the rare disease, Phenylketonuria (PKU). You'll collaborate closely with internal teams, CROs, and vendors to ensure the smooth execution of our clinical studies. This role is best suited for someone who is organized, detail-oriented, and proactive. The ideal candidate enjoys problem-solving, thrives in a fast-paced environment, and is eager to take ownership of critical trial activities such as vendor and site management. The Impact You'll Have You'll be a critical part of our clinical team, ensuring our trials are executed with precision, efficiency, and the highest standards of quality. Your contributions will include: • Driving Study Execution: Partner with the Clinical Operations team to oversee and monitor the conduct of our global Phase 2 PKU study, monitoring and tracking progress, identifying trends or issues, and collaborating with Study Leads to implement corrective actions when necessary., • Site, Vendor Management & Oversight:, • Lead site management oversight (e.g., reviewing reports, conducting QC checks, escalating trends to Global Site Manager) to ensure CRO activities align with the study plans and protocol. Facilitate any deviation discussions for quick resolution. Identify site trends, opportunities for training, and creating tracking tools to ensure sponsor oversight., • Manage one or more clinical trial vendors from study-start to close-out, including day-to-day management, budget oversight, and escalating to Study Lead as, appropriate., • Identify gaps quickly, hold vendors/CRAs accountable, provide solutions, and escalate risks in a timely manner., • Ensuring compliance & Best Practices: Ensure that all clinical trial activities adhere to ICH/GCP Guidelines, study plans and protocols, and Maze SOPs., • Supporting Key Study Materials: Assist in the design, development, and review of study documents, including protocols, informed consent forms (ICFs), amendments, and content creation for study materials., • Collaboration & Leadership: Attend and contribute to vendor meetings, lead resolution of study-related issues, and foster a culture of continuous process improvement with CROs and other external partners., • Tracking & Documentation: Oversee Trial Master File (TMF) activities, ensuring proper documentation, metric tracking and reconciliation efforts as needed., • Sample & Data Management: Work with study team to coordinate and track sample shipments, sample analysis, and data reconciliation efforts., • Cross-Functional Collaboration: Serve as a point of contact for study-related inquiries and provide high-level administration, coordination, and organizational support to the Clinical Operations team., • Process & SOP Development: Contribute to creation and refinement of Clinical Operations standard operating procedures (SOPs) and process documents to optimize study execution. What We're Looking For We're looking for someone who's not just checking the boxes but is truly passionate about bringing high quality clinical trials to life. You might be a great fit if you have: • A strong clinical operations background: Bachelor's degree with 2-3+ years of experience in Clinical Operations within a biotech or pharmaceutical environment., • A systematic and problem-solving mindset: You enjoy solving complex challenges and thinking critically to improve processes., • Exceptional organizational skills: You can manage multiple priorities, staying detail-oriented, and keep trials on track., • A proactive and collaborative approach: You're a strong team player who takes initiative and builds meaningful relationships with internal and external partners., • Hands-on experience with trial systems: Familiarity with clinical trial databases such as Medidata Rave, Veeva, or similar platforms., • Flexibility and adaptability: You thrive in a fast-paced, evolving environment and willing to roll-up your sleeves to perform a broad range of clinical trial related tasks as needed., • Willingness to travel: Up to 10-15% travel, with the possibility of more based on project needs as necessary., • Strong computer proficiency (Microsoft Office Suite- Word, Excel, Outlook). This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least two days per week. About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company's pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease. Maze is based in South San Francisco. Our People Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients. Our Core Values Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we'll achieve our mission. Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others. Stand True – Our integrity is foundational; it guides us no matter the obstacle. The expected annual salary range for employees located in the San Francisco Bay Area is $125,000 to $152,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future. Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy. #LI-Hybrid

Job Description Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell's product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency. This role can be based out of either our South San Francisco, CA or Seattle, WA offices. The incumbent will lead a program anticipated to grow to include multiple trials. This role will oversee the teams involved in the trials. KEY ROLE AND RESPONSIBILITIES: • Leads the development of strategic planning for assigned clinical trial portfolio including timelines, budgets and resourcing (internal and external), • Oversight of operational feasibility; making decisions on recommendations and solutions to align with study and patient needs, • Oversees study execution; manages risks in timeline, budget and quality, advises the team on actions to mitigate these risks, • Ensures the cross-functional team is aligned with tactics and plans; addresses issues directly to resolve concerns, • Leads the development of talent; ensuring coaching and performance management is conducted in a timely Guides leaders in talent management. Models the Lyell Leader Behaviors., • Supports TMF maintenance activities through timely filing of study and vendor documents as needed., • Oversees TMF quality by reviewing TMF health and works with CTM to develop mitigation strategies to ensure TMF issues are Escalates any TMF-related needs (vendors, systems) to senior leadership as needed, to support TMF health., • Develops the department; collaborates with VP Clinical Operations to ensure processes and procedures are in place as needed for the maturity of the, • Effectively manages budgets and resources to meet goals andPREFERRED EDUCATION:, • BSc with a minimum of 17 years' experience, • MSc with a minimum of 14 years' experiencePREFERRED EXPERIENCE:, • A minimum of 8 years' experience in Oncology drug development and cell therapy experience, • A minimum of 3 years' experience in early-stage drug programs, • Proven experience in the design and development of clinical trial program, • Prior experience with BLA submissions and regulatory authority inspections desirableKNOWLEDGE, SKILLS AND ABILITIES:, • Demonstrated knowledge of collaborating and managing CROs and other external vendors to deliver successful trial outcomes, • Proven ability to lead broad clinical operations teams and effectively lead cross-functional study execution teams, • Has in depth understanding of FDA regulations and ICH GCP guidelines; successfully applied these to studies to drive effective, efficient and timely strategiesLyell offers its employees a range of compensation and benefits. The salary range for this position is $200,000 to $240,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell's compensation practices and an applicant's qualifications and experience. Employees are also eligible to participate in Lyell's Equity Incentive Plan. At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.We've learned from experience that some of the best people don't always match our requirements perfectly - if you're interested and think you could fit, please don't hesitate to apply.

Job Description Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an exceptionally motivated individual to provide leadership and support to global regulatory activities to achieve Alumis' strategic vision in obtaining worldwide approvals to market our products. The individual will represent Regulatory Affairs and work closely with cross-functional study teams and technical regulatory service providers in accordance with health authority and ICH requirements. In addition to being a key member of our project teams, she/he will provide organizational support as the company and its product development pipeline grow. This role will be reporting to the Director of Regulatory Strategy. ESSENTIAL DUTIES & RESPONSIBILITIES · Serve as the Regulatory Affairs representative for Phase 1 to Phase3 trials, ensuring regulatory activities are evaluated, prioritized and executed to meet global regulatory requirements. · Serve as the Regulatory Affairs representative on assigned study teams and assure the progress of studies by addressing regulatory related queries in support of regulatory approvals. · Lead preparation, review and submission of INDs/CTAs, amendments, review and approval of investigator document packages and manage other regulatory activities of the assigned studies as needed. · Establish and meet timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities, while planning for Phase 1 to 3 trials. · Interact with Contract Research Organization (CRO) Regulatory Affairs counterpart. · Maintain awareness of current regulatory requirements and communicate requirements in support of regulatory approvals. EDUCATION/EXPERIENCE/SKILLS: · Bachelor's or advanced degree in scientific discipline, with a minimum of 5 years of experience working in drug development in the biopharmaceutical industry and at least 3 years of experience in Regulatory Affairs; immunology or rare disease/ orphan drug development experience desirable. Knowledge/Skills/Abilities: · Direct experience with pharmaceutical global regulatory submissions and contributing to major regulatory filing(s) such as IND/CTA. · Working knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices. · Demonstrated experience in successfully leading assigned activities within cross-functional teams. · Excellent verbal and written communication skills. · Collaborative, analytical and interpretative skills that enable review and compilation of reports and other documents used in regulatory planning and submissions. · Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others, prior management experience a plus. · Responsibilities may require a work schedule that may include working outside of "normal" work hours, to meet business demands. The salary range for this position is $165,000 USD to $195,000 USD annually paid hourly per contract. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices.