Clinical trials management jobs in Chula Vista, CaliforniaCreate job alerts

ROLE SUMMARY Today, Pfizer Oncology has an industry-leading portfolio of 25 approved innovative cancer medicines, including major therapies for metastatic breast cancer, prostate cancer, urothelial carcinoma, and hematologic malignancies. Pfizer’s in-line portfolio is focused on four broad, key areas: breast cancer, genitourinary cancer, hematology, and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development. • The Oncology Scientific Communications Director will report to the Team Lead within Pfizer Oncology Medical Strategy Management, • The Oncology Scientific Communications Director will lead the development and execution of impactful scientific communication strategies for assigned Pfizer medicines and across their tumor area, with a focus on achieving a singular scientific voice anchored to the evidence., • The Director will ensure that overall scientific communication and content strategies reflect TA priorities and that tactical execution of medical and scientific communication activities, specifically focused on optimizing the engagement and reach of emerging scientific information within the oncology community, occurs successfully and according to strategy., • This role will focus on achieving a singular scientific voice anchored to the evidence, optimizing the engagement, consistency and reach of emerging scientific information within the oncology community. They will be a subject matter expert in one of the three below chosen capabilities:, • Therapeutic Area (TA) Scientific Communications: ensure asset strategies and messaging are seamlessly integrated into TA-specific plans and materials. The TA Sci Comms lead will also focus on the delivery of foundational resources such as Scientific Communications Platforms (SCPs), Narratives, and FAQs., • Data Disclosure (Publications): Collaborate with TA teams and Sci Comms colleagues to drive the publication planning, writing, and dissemination of scientific data from clinical trials and research activities, ensuring a cohesive and impactful publication strategy across the portfolio., • Medical Content: Create a wide range of engaging and informative scientific content for diverse channels and audiences, including medical to medical resources, congress and digital platform content. ROLES AND RESPONSIBILITIES The Director will be responsible for the following, with specific responsibilities varying based on the chosen Sci Comms functional focus area (TA, Data Disclosures, or Content). This role may require working across two functional areas for one product/program. General Responsibilities (applicable to all focus areas): • Responsible for ensuring strategic input from a broad range of stakeholders (internal and external) is integrated into scientific communications strategic planning to meet the needs of these stakeholders and especially the Oncology Medical TA teams, • Support Global Product Teams, Global Medical franchises, and other Pfizer Oncology stakeholders in engaging with the external medical community on activities related to key clinical trial data readouts., • Ensure alignment of each product’s overall scientific content/communications strategy with relevant Pfizer Oncology stakeholders (e.g., partnering with cross-functional Medical Teams, Channel Excellence, Data Analytics, and other key stakeholders to ensure alignment of communication plans with medical priorities and optimize opportunities for broader data dissemination), • Act as a strategic thought partner to the TA medical team, providing sci comms functional guidance and subject matter expertise in their designated focus area, • Leads financial projections and budget management for functional deliverables in addition to managing agencies and off-shore teams (if applicable), • Collaborate with International Medical Channel Content team to ensure sci comms deliverables are shared with country medical colleagues for adaptation, • Have a thorough understanding of therapeutic area assigned, including policy related issues, and the individual inline and pipeline assets across the specific TAs with an ability either to serve as a primary point of contact for accurate, current medical and scientific knowledge or to identify the appropriate Subject Matter Expert within therapeutic area, for internal and external stakeholders and customers., • Responsible for building collaborative relationships with relevant partners in and outside of Medical to ensure optimal creation and execution of channel-specific TA medical communications strategies., • Stay abreast of US regulations and guidance that impact digital delivery of scientific information to external HCPs TA Communications: • Accountable for strategic oversight of TA scientific communication activities and the overarching scientific communications objectives/strategy/narrative, ensuring alignment and excellence in delivery, • As a core member of the Global Medical Affairs Team (GMAT), responsible for identifying the need for and establishing the Scientific Communications Platform (SCP) for TA products early in development based on target profile, clinical evidence, disease state/landscape, and aspirational label., • For later life-cycle assets, determine the need for and enrich the SCP (based on wide cross-functional input) with evolving evidence from clinical studies, insights, the Clinical Development Plan and regulatory strategy to ensure teams use accurate, consistent language, • Ensure the product-level SCP is aligned to the broader Therapeutic Area, tumor and/or modality scientific narrative and that information is pulled through to all scientific communication deliverables, • Establish and maintain the Scientific Communication Platform (SCP) for products in their TA, including overarching scientific communication objectives., • In addition to Therapeutic Area and Asset-specific SCPs, the TA Sci Comms lead is responsible for developing global medical narratives and FAQs around key data disclosures, • Work closely with clinical/medical teams during data readouts to determine key messages (aligned to the SCP), • Collaborate with non-Medical stakeholders (e.g. Scientific Affairs, Corporate Communication, etc.) to ensure consistency of scientific communications for non-medical audiences., • Orchestrate OLT (Oncology Leadership Team) informs/reviews of key disclosures., • Co-chair medical/sci-comms sub-committee(s) of the GMAT Data Disclosure (Publications): Focus: • Drive and deliver on data disclosure plans, including Plain Language Summaries (PLS) and Enhanced Publication Content (EPC), • Manage author reviews and preparedness, • Chair Scientific Publications Committees (SPCs), • Work closely with clinical study teams during data readouts to determine publication content, • Ensure updates to global publication plans occur as needed on a regular basis, • Support GPTs, Global Medical franchises, and other Pfizer Oncology stakeholders by engaging with the external medical community on publication activities., • Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Content Focus: • Lead above or specific-therapeutic area content strategies, projects, digital initiatives and broad enterprise-wide initiatives to advance content impact throughout the organization across all medical content on externally- and internally-facing medical channels, • Define and deliver external Global and US medical-to-medical content for Field/HQ/Congresses; congress content, digital medical platforms, and content for newly prioritized medical channels., • Ensure updates to global congress content occurs as needed on a regular basis in coordination with key cross-functional stakeholders, including commercial, development and Medical TA teams and platforms., • Responsible for ensuring the creation of field medical content is aligned with the needs of the Pfizer Oncology Global Medical TA team and regional/local Medical Affairs., • Proactively resolve issues around content creation, combining medical affairs expertise with an understanding of the patient, healthcare professional, legal, regulatory, and organized customer points of view., • Define and deliver TA training content with support from Platform training teams when applicable., • Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT., • Note: while colleagues will typically focus on one of these areas, there is an expectation that if a business need arises, the team member can adapt and support other functional focus areas. QUALIFICATIONS • Bachelor’s degree with a minimum of 10 years of relevant biopharmaceutical/biotech or agency experience (such as Medical Communications, Medical Affairs or scientific communications within Clinical Development roles)., • Advanced scientific degree (PhD, PharmD, MS, etc.) preferred, • Experience developing strategic scientific communications and other scientific content to support scientific exchange, including the use of tools and programs to meet the needs of HCPs., • Have a strong understanding of Medical Affairs, including medical strategies, disease areas, and objectives., • Ability to quickly build rapport and credibility with key internal and key external stakeholders through strong interpersonal skills; strong matrix leadership, • Demonstrated ability to translate complex scientific concepts and data into meaningful and digestible communications and foundational tools that can be utilized via multiple channels including at scientific conferences., • Strong track record of written and oral communication skills to develop and present scientific information to varied audiences and articulate messages succinctly., • Strong organizational skills to track numerous tasks for multiple simultaneous projects in a deadline-oriented environment., • Experience working in a highly regulated environment and delivering scientific content in a compliant yet innovative manner, leveraging the latest technologies to ease the consumption of critical scientific information., • Experience with omnichannel, including diverse content development – such as publications, plain language summaries, Congress materials, publication extenders, podcasts, and short-form articles for 3rd party digital platforms., • Experience with scientific peer-reviewed publications. PREFERRED QUALIFICATIONS • Oncology experience strongly preferred., • Advanced medical/scientific degree (MS, PhD, PharmD), with 8+ years’ experience (if Masters) or 6+ years’ experience (if PhD or PharmD) NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Travel 15-20% #LI-PFE Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week. The annual base salary for this position ranges from $169,700.00 to $282,900.00.* In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. • The annual base salary for this position in Tampa, FL ranges from $152,700.00 to $254,500.00. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make ___ accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email ___. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Medical

POSITION SUMMARY You will lead and coordinate the development of multiple studies of novel biological and small molecules for first in human (FIH), proof of mechanism (POM), early signs of efficacy (ESOE) and proof of concept (POC) studies in Oncology. You will work in close collaboration with the Global Development Lead (GDL)and members of the development team to establish, lead, coordinate, and execute the early oncology clinical development plan(s). You will lead the development of the clinical protocol and participate as an individual contributor on clinical teams with Pfizer development operations and the project team, to meet enrollment and study delivery timelines. You will also work with other functional disciples to ensure the full scope and remit of Oncology Early Stage Development (OESD) is represented as need within clinical study teams (e.g. Research Units, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine). POSITION RESPONSIBILITIES * Partner closely with the Global Development Lead (GDL) in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s) * Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results * Support execution for all FIH programs through proof-of concept * Set the clinical data review strategy, ensure quality data and conduct review of emerging clinical data and trends; review and query data; present and discusse relevant data to appropriate teams, governance bodies, and other internal and external stakeholders * Conduct data review, analysis and interpretation of clinical trials data together with the GDL, Clinical Safety, and Biostatistics. * Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors * Support and assist in the development of publications, abstracts, and presentations * May sit on project teams to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials. * Participate in project teams to help implement clinical development and contribute to key milestones (e.g., start-up and delivery of early signs of efficacy [ESoE] and POC trials). * Lead the preparation of clinical protocols and support other critical documents including clinical development plans, INDs, annual reports, clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. * Foster a transparent environment that builds strong partnerships and mutual trust among teams and therapeutic areas. * Coordinate with other clinical research activities within Oncology Research Development (ORD) and the broader Worldwide Research and Development (WRD) organization. * Develop effective collaborations with key internal and external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision medicine, and development operations. * Partner with Translational Oncology and Biomarker teams to ensure biomarker plans are integrated into relevant programs for early efficacy signs and POC, as well as patient stratification. * Establish and support relationships with external experts, consultants, key opinion leaders, regulators, and investigator networks to integrate the latest clinical thinking and guidelines into development plans and study designs, as well as manage study recruitment, analysis, interpretation, and presentation of results. * Maintain up-to-date knowledge of scientific and clinical literature in relevant therapeutic areas, including key clinical development issues. * Perform other duties as assigned related to clinical programs. * Support functional area priorities and contribute to or lead departmental initiatives as requested. MINIMUM QUALIFICATIONS / KEY SKILLS * Relevant PhD or PharmD and a minimum of 5 years of experience in a similar role in industry/CRO, OR * MS and a minimum of 7 years of experience in a similar role in industry/CRO, OR * BA/BS and a minimum of 10 years of experience in a similar role in industry/CRO * Clinical Research experience in Phase 1 in Oncology, on the side of the sponsor leading studies * Experience in or strong understanding of Oncology Drug Development especially in Early Development * Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations. * Strong scientific writing skills and communication skills (written and verbal) * Clinical document writing experience (e.g., protocol, ICD, IB, IND), as well as understanding complex data analysis. * Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations. * Experience working with and solid understanding of related disciplines, e.g., Clinical Operations, Data Management, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance. * Experience building consensus and driving change across all levels of the organization including senior management. * Data listing review experience * Critical thinker, with experience working collaboratively in a fast-paced, team-based matrix environment as well as working independently when appropriate * Experience performing complex data analyses using JReview, SpotFire, SOCs-PRO or other similar platform PREFERRED QUALIFICATION * Experience leading a team Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. PHYSICAL/MENTAL REQUIREMENTS Perform complex data analysis NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS 5-10% Travel Work Location Assignment: Hybrid The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make ___ accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email ___. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Medical

POSITION SUMMARY You will lead and coordinate the development of multiple studies of novel biological and small molecules for first in human (FIH), proof of mechanism (POM), early signs of efficacy (ESOE) and proof of concept (POC) studies in Oncology. You will work in close collaboration with the Global Development Lead (GDL)and members of the development team to establish, lead, coordinate, and execute the early oncology clinical development plan(s). You will lead the development of the clinical protocol and participate as an individual contributor on clinical teams with Pfizer development operations and the project team, to meet enrollment and study delivery timelines. You will also work with other functional disciples to ensure the full scope and remit of Oncology Early Stage Development (OESD) is represented as need within clinical study teams (e.g. Research Units, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine). POSITION RESPONSIBILITIES * Partner closely with the Global Development Lead (GDL) in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s) * Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results * Support execution for all FIH programs through proof-of concept * Set the clinical data review strategy, ensure quality data and conduct review of emerging clinical data and trends; review and query data; present and discusse relevant data to appropriate teams, governance bodies, and other internal and external stakeholders * Conduct data review, analysis and interpretation of clinical trials data together with the GDL, Clinical Safety, and Biostatistics. * Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors * Support and assist in the development of publications, abstracts, and presentations * May sit on project teams to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials. * Participate in project teams to help implement clinical development and contribute to key milestones (e.g., start-up and delivery of early signs of efficacy [ESoE] and POC trials). * Lead the preparation of clinical protocols and support other critical documents including clinical development plans, INDs, annual reports, clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. * Foster a transparent environment that builds strong partnerships and mutual trust among teams and therapeutic areas. * Coordinate with other clinical research activities within Oncology Research Development (ORD) and the broader Worldwide Research and Development (WRD) organization. * Develop effective collaborations with key internal and external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision medicine, and development operations. * Partner with Translational Oncology and Biomarker teams to ensure biomarker plans are integrated into relevant programs for early efficacy signs and POC, as well as patient stratification. * Establish and support relationships with external experts, consultants, key opinion leaders, regulators, and investigator networks to integrate the latest clinical thinking and guidelines into development plans and study designs, as well as manage study recruitment, analysis, interpretation, and presentation of results. * Maintain up-to-date knowledge of scientific and clinical literature in relevant therapeutic areas, including key clinical development issues. * Perform other duties as assigned related to clinical programs. * Support functional area priorities and contribute to or lead departmental initiatives as requested. MINIMUM QUALIFICATIONS / KEY SKILLS * Relevant PhD or PharmD and a minimum of 5 years of experience in a similar role in industry/CRO, OR * MS and a minimum of 7 years of experience in a similar role in industry/CRO, OR * BA/BS and a minimum of 10 years of experience in a similar role in industry/CRO * Clinical Research experience in Phase 1 in Oncology, on the side of the sponsor leading studies * Experience in or strong understanding of Oncology Drug Development especially in Early Development * Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations. * Strong scientific writing skills and communication skills (written and verbal) * Clinical document writing experience (e.g., protocol, ICD, IB, IND), as well as understanding complex data analysis. * Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations. * Experience working with and solid understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance. * Experience building consensus and driving change across all levels of the organization including senior management. * Data listing review experience * Critical thinker, with experience working collaboratively in a fast-paced, team-based matrix environment as well as working independently when appropriate * Experience performing complex data analyses using JReview, SpotFire, SOCs-PRO or other similar platform PREFERRED QUALIFICATION * Experience leading a team This position does not require you to be medical qualified. Demonstrates diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. PHYSICAL/MENTAL REQUIREMENTS Perform complex data analysis NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS 5-10% Travel Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week. Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. PHYSICAL/MENTAL REQUIREMENTS Perform complex data analysis NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS <10% Travel Work Location Assignment: Hybrid The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make ___ accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email ___. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Medical

Job Description Faro Health aims to improve lives by helping life sciences companies answer complex clinical questions, simply, efficiently and effectively. Our software platform is used to orchestrate complex clinical development with a single source of truth. It brings words, data and teams together, empowering researchers to design more intelligent trials, master complexity and reach milestones faster. We are seeking a highly organized, proactive, and detail-oriented individual to join our team as an Operations & Administration Manager. In this multifaceted role, you will provide essential support across marketing, customer operations, financial operations, contract management, and company-wide event coordination. You will manage complex calendars, lead logistical planning, maintain critical operational workflows, and support cross-functional initiatives that drive efficiency across the organization. The ideal candidate thrives in a fast-paced environment, demonstrates exceptional communication and multitasking skills, and is comfortable working both independently and collaboratively. This is a full-time position (approximately 40 hours per week) with a requirement to work in the office three days per week. This is a temporary to hire role. Requirements Duties and Responsibilities Events, Travel & Meeting Operations • Oversees planning and execution of company-wide events, including All Hands, ACR, conferences, and external engagements., • Manages end-to-end travel logistics for leadership and teams, ensuring seamless coordination across flights, accommodations, and meeting spaces., • Leads scheduling and operational support for key customer, partner, and offsite meetings., • Manage customer onboarding, project setup, and system alignment across HubSpot and Scoro., • Maintain sales workflows, documentation, travel coordination, conference registrations, and bid submissions., • Support post-event engagement, follow-ups, and revenue-related operational tasks., • Submit, track, and maintain all contracts and invoices for vendors, partners, contractors, and customers., • Manage monthly COGS updates and oversee team and project time tracking within Scoro to support accurate billing and reporting., • Maintain a comprehensive customer invoice log, track incoming receipts, and reconcile all payments in alignment with internal controls., • Confirm deposit of miscellaneous paper checks and ensure all financial records are accurate and complete., • Monitor and track business travel expenses, manage flight tracking, and validate out-of-budget travel requests against policy., • Oversee website updates, blogs, press releases, job postings, and digital publishing workflows., • Manage LinkedIn presence, podcast scheduling, webinar hosting, and promotional campaigns., • Create branded materials and conference collateral in Canva to support marketing and sales initiatives. Qualifications: • Proven experience in executive-level administrative and operational roles, preferably within a fast-paced corporate or technology environment., • Demonstrated ability to manage complex workflows across marketing, revenue operations, customer onboarding, legal processes, and financial administration., • Skilled in coordinating cross-functional programs, including contract lifecycle management, vendor operations, conference logistics, and company-wide events., • Advanced proficiency with Google Workspace and strong competency across Microsoft Office Suite (Word, Excel, PowerPoint), Zoom, Teams, and other collaboration platforms., • Hands-on experience with CRM and work management systems such as HubSpot, Scoro, and related sales-enablement and project-tracking tools., • Light bookkeeping and accounting skills, including basic invoice tracking, time-tracking oversight, expense reconciliation, and maintaining accuracy in financial records and internal controls., • General experience supporting digital marketing activities, including basic website updates, social media coordination, content publishing, and assistance with webinars, podcasts, and promotional campaigns., • Highly organized and detail-oriented, with the ability to prioritize competing demands and maintain accuracy across multiple operational domains., • Exceptional written and verbal communication skills, with demonstrated ability to create clear, branded materials and professional documentation., • Trusted to handle sensitive information with discretion, and confidentiality., • Technologically savvy, with the ability to learn new systems quickly and optimize processes for efficiency and consistency., • Ability to work on-site three days per week and support travel, event, and operational activities as needed. Salary • Salary range for this position is $96,000 to $106,000, • Retirement Plan (401k), • Flexible work hours, • Hybrid work environment, • Office Gym Access, • Employee Restaurant Discounts

Job DescriptionCompany Description ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib (ORIC-114), a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to , and follow us on X or LinkedIn. Reporting to the Executive Director, of IT, ORIC is seeking a strategic and hands-on IT leader to support late-stage Development functions across Clinical, Regulatory, Quality, and Drug Safety. This role will drive digital enablement and compliance for Phase 3 programs, ensuring that systems and processes meet global regulatory standards and are ready for inspection. The ideal candidate will bring deep expertise in Veeva platforms, Computer System Validation (CSV), and regulatory frameworks such as 21 CFR Part 11. By collaborating with stakeholders across Clinical, Safety, Regulatory, Portfolio & Project Management, and other Development functions, you will ensure data is discoverable, interoperable, and analytics-ready. Job Description • IT Business Partnership & Strategy, • Serve as the primary IT partner for Phase 3 Development functions, aligning technology solutions with business needs., • Collaborate with Clinical, Safety, Regulatory, Portfolio & Project Management, and other Development functions and teams to support digital transformation initiatives., • System Ownership & Implementation, • Lead implementation and optimization of Veeva Vault applications (e.g., Quality Docs, QMS, RIMS)., • Gather application business requirements and systems goals from business owners and translate them into technical requirements., • Oversee system lifecycle management, including upgrades, integrations, and vendor coordination for SAS, Box.com, and Extedo., • Collaborate with domain leaders, governance, and platform teams to ensure seamless integration of Developement systems., • Compliance & Validation, • Ensure systems are validated per GxP requirements and compliant with 21 CFR Part 11., • Lead the IT GDPR compliance program., • Own CSV documentation and audit readiness for IT-supported platforms., • Inspection Readiness & Support, • Partner with QA and Regulatory to prepare for health authority inspections., • Provide IT support during inspections, including system demonstrations and documentation., • Project & Change Management, • Lead cross-functional projects from concept through deployment., • Manage change control processes and ensure stakeholder alignment., • Manage the UAT planning, execution, and reporting.Qualifications, • Bachelor’s or Master’s degree in Computer Science, Life Sciences, or related field., • 8+ years of experience in IT supporting development functions in the biopharma industry., • Strong knowledge of Veeva Vault applications and their configuration., • Proven experience with CSV, GxP systems, and 21 CFR Part 11 compliance., • Familiarity with Phase 3 clinical trial operations and regulatory submission processes., • Good understanding of industry data standards (CDISC, MedDRA, HL7, etc.)., • Experience in R&D data domains and lifecycle., • Experience supporting global clinical trials and regulatory submissions., • Prior involvement in inspection readiness or direct participation in regulatory audits., • Knowledge of Quality Management Systems (QMS). Additional Information The anticipated salary range for candidates who will work in our San Diego location is between $200,000-$250,000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc. ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.

Medical Science Liaison, Gene Therapy/Rare Disease (West) Be at the Forefront of Revolutionary Gene-Editing Therapies The Medical Affairs Company (TMAC) is seeking visionary Regional Scientific Director (RSD) to join an expanding global field medical team. This is your opportunity to set the standard for a new class of medicine and make a lasting impact in the field of gene therapy. About The Role As a Regional Scientific Director, you will: • Spearhead the education of Principal Investigators, Centers of Excellence, Key Opinion Leaders, and healthcare teams on cutting-edge CRISPR-based gene editing technologies, • Play a crucial role in our client's groundbreaking Phase 3 trials for Hereditary Angioedema and ATTR amyloidosis with cardiomyopathy, • Bridge the gap between clinical development and real-world application of revolutionary therapies Key Responsibilities • Foster strong relationships with investigators and institutional stakeholders to optimize clinical trial execution, • Provide expert scientific support and operational insights to study sites, • Develop and implement strategies to enhance patient recruitment and site activation, • Educate stakeholders on CRISPR/Cas9 technology and emerging approaches in disease management, • Gather and analyze valuable insights on patient experiences and healthcare system dynamics Ideal Candidate Profile • Doctorate level degree (Pharm.D., Ph.D., M.D., or D.O.) with 5+ years of industry or related field experience, • Extensive clinical or clinical trial experience in rare diseases or genetic medicine. Priority given to candidates with HAE experience, • Prior experience as a Medical Science Liaison or Clinical Trial Liaison, • New product launch experience (preferred), • Exceptional communication and presentation skills, • Strategic thinker with the ability to influence and drive results, • Passion for advancing medical science and improving patient outcomes What We Offer • Opportunity to work with cutting-edge gene-editing technologies, • Collaborative and innovative work environment, • Competitive salary commensurate with experience and expertise, • Chance to make a significant impact on patient lives and the future of medicine Are you ready to shape the future of medicine? Join us in revolutionizing healthcare through gene therapy. Apply now to be part of this exciting journey! Note: This position requires 50-70% travel, including overnight stays. Candidates must have a valid driver's license and the ability to manage a geographically assigned territory from a home-based office. Salary offers to be determined based on industry experience, education, and therapeutic expertise.

Job DescriptionDescription: SUMMARY The Clinical Trial Assistant (CTA) will provide administrative support to the Clinical Operations Team in full spectrum of clinical trial activities related to study start up, study maintenance, study closure and vendor management in compliance with Good Clinical Practice (GCP), Standard Operation Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. ESSENTIAL DUTIES AND RESPONSIBILITIES The main responsibilities of this role include but are not limited to the following: • Assist with review, formatting and finalizing clinical protocols and other key study documents such as reports, Study Master ICF Template, etc., • Provides administrative support with various tasks such as review and formatting of documents including follow-up on various tasks, updating project timelines, etc., • Performs other duties as required. Requirements: EDUCATION AND EXPERIENCE REQUIREMENTS • Bachelor’s Degree in a related field., • Preferred but not required, minimum of one-year relevant clinical trial experience in the pharmaceutical and/or biotechnology industry., • Preferred but not required, prior experience as a CTA and/or knowledge of FDA, ICH, GCP, CFR guidelines, regulatory requirements and clinical trials operations. KNOWLEDGE AND SKILLS REQUIREMENTS • The scope of this position requires strong organizational, communication, and administrative skills including proficiency in Microsoft Office Suite such as Word, Excel, PowerPoint., • Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential., • Requires good organization, documentation and interpersonal skills., • Ability to work independently as well as within a team-oriented environment., • Strong attention to detail. VIKING THERAPEUTICS Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Notice to Agency and Search Firm Representatives Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Job DescriptionThe Vice President, Clinical Development will serve as the strategic clinical lead for one or more of Janux’s IND programs and/or ongoing clinical trials in solid tumors or hematologic malignancies. The ideal candidate will demonstrate a proven track record of success in clinical trial leadership within academic, biotechnology, and/or pharmaceutical industries, with a strong emphasis on developing and executing clinical strategy, interpreting clinical data, and fostering productive relationships with industry KOLs, medical experts, and investigators. While experience in medical monitoring is important, the primary focus of this role is on strategic oversight and leadership of clinical development programs.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: • Provide strategic oversight and direction for one or more clinical trial programs, ensuring alignment with organizational goals and regulatory requirements, • Lead the design, development, and implementation of clinical trial strategies and plans in partnership with Pre-clinical R&D, Clinical Operations, Regulatory Affairs, Quality Assurance, and Janux’s Management Committee, • Oversee the execution of clinical development programs, including protocol development, data interpretation, and decision-making at key program milestones, • Serve as a source of medical expertise and provide high-level guidance to cross-functional teams, clinical project staff, and investigative sites, • Perform the duties of a Medical Monitor as needed to ensure clinical integrity and patient safety, while delegating operational aspects where appropriate, • Provide subject matter expertise and medical review and/or input within the preparation of medical components of clinical trial and regulatory documents which may include, but is not limited to the following: Clinical Development Plans, Clinical Study Reports, Investigator Brochures, SAE Narratives, INDs, and/or Annual Reports, etc., • Contribute to CRO, clinical site and investigator training; actively interact with CROs, clinical sites and investigators regarding study implementation, • Respond to clinical questions from sites, IRBs/IECs, Health Authorities and CROs, • Review, interpret and present clinical data to both internal and external key stakeholders, • Establish and maintain relationships with KOL’s, medical experts and investigators in the area of Immuno-Oncology and more importantly, within the genitourinary disease areas, • Other duties as deemed essentialEDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES, • MD or DO with a subspeciality in Oncology, more specifically in the treatment of genitourinary cancers is required, • Successful completion of post-graduate training or residency in Oncology, along with board certification or board eligibility is highly desirable, • Minimum 8 years of experience within biotechnology, pharmaceutical or relevant academic institutions required, • Expert level understanding of early drug development and clinical trial processes with a track record of leading clinical development programs is essential, • Knowledge of GCP and ICH guidelines and regulatory requirements for the conduct of Oncology clinical trials, particularly in the treatment of prostate cancer, • Strong ability to critically evaluate data, literature, and presentations Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. 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 Orso Health is a leading organization in clinical research, dedicated to advancing healthcare through innovative studies. We are committed to excellence in research and invite you to be part of our dynamic team. California and the Arizona market. Known for our high standards of excellence, we are committed to providing compassionate, patient-centered care for both pediatric and adult patients. Our dedicated team strives to improve lives through the expert diagnosis and treatment of a wide range of allergy and asthma conditions. We are looking for high-energy, kind, and collaborative individuals who are eager to grow personally and professionally to join our team. Position Summary We are seeking an experienced Clinical Research Site Manager to lead operations across multiple clinical research sites, with primary responsibility for our La Jolla, CA location. This role provides leadership to Clinical Research Coordinators at more than one site and ensures consistent, high-quality, compliant execution of clinical studies. The Site Manager will oversee staff development, operational efficiency, regulatory compliance, and data quality, while ensuring data integrity and high standards of research conduct across all assigned sites. This position requires travel, with occasional support at our Los Angeles clinic sites in Torrance, Long Beach, Scottsdale AZ. This role is an exempt, full-time role, working standard business hours with flexibility for early or late visits as needed for study conduct. 40 hours per week, Monday through Friday, onsite in our La Jolla Clinic. Key Responsibilities Multi-Site Leadership & Operational Oversight: • Provide operational leadership and management across multiple clinical research sites, ensuring consistency in workflow, quality, and compliance., • Hire, onboard, train, and evaluate Clinical Research Coordinators and support staff across sites., • Monitor staffing levels and coordinate resource allocation across all active trials and locations., • Oversee day-to-day clinical operations, visit scheduling, and subject care across sites., • Ensure research staff at all locations follow protocols, SOPs, GCP, and institutional policies., • Maintain and document training standards across all assigned sites., • Contribute to patient recruitment and retention strategies across the site network., • Supervise the implementation and adherence to study protocols across multiple sites., • Ensure timely and accurate source documentation and data entry at each location., • Ensure all sites meet electronic regulatory requirements and maintain audit-ready regulatory documentation., • Monitor data quality across locations to ensure accuracy, completeness, consistency, and data integrity., • Conduct remote or onsite monitoring visits at various sites to review source documents, CRFs, and regulatory materials., • Maintain data integrity and research conduct through ongoing oversight and timely resolution of data discrepancies., • Coordinate and support external monitoring visits across locations, including preparation, communication, and follow-up., • Document monitoring activities in compliance with SOPs, GCP, and ICH guidelines., • Assist in audit preparation and regulatory inspections across multiple sites., • Maintain compliant regulatory files and electronic systems for each assigned location., • Identify operational or documentation gaps across sites and support corrective and preventive action plans., • Perform additional responsibilities as needed to support multi-site clinical operations. Skills & Qualifications, • Education: Bachelor's degree in life sciences, healthcare, or related field., • Experience:, • Minimum of 5 years of experience in clinical research, preferably involving multi-site management, monitoring, or data oversight., • Prior supervisory or team leadership experience strongly preferred., • Strong working knowledge of FDA regulations, ICH-GCP, and clinical trial operations, • Skills & Abilities:, • Strong understanding of GCP, ICH guidelines, and end-to-end clinical trial operations across multiple sites., • Excellent attention to detail and organizational skills, particularly in multi-site environments., • Strong communication skills to effectively support and coordinate cross-site teams., • Proficiency with CTMS, EDC platforms, electronic regulatory systems, and Microsoft Office Suite., • Analytical mindset with strong problem-solving capabilities., • Ability to manage priorities effectively across multiple locations., • Commitment to quality, data integrity, ethical research conduct, and regulatory compliance. Physical Requirements Ability to stand, walk, and move throughout the clinic, if applicable, for extended periods; occasionally lift objects up to 25 lbs., bend, stoop, or reach as needed. Frequent use of hands and fingers for patient care and equipment operation. Must have normal (or corrected) vision and hearing and be able to respond quickly in a fast-paced clinical environment, if applicable. What We Offer • Competitive salary and benefits package, including medical, dental & vision insurance, 401(k) retirement plan with employer matching, and professional development opportunities, • In addition, we offer paid time Off (PTO), sick time, floating holiday and holiday pay, • Opportunity to shape the future of cutting-edge clinical research in beautiful San Diego (and across our expanding network) California Consumer Privacy Act (CCPA) Notice Orso Health ("OH") complies with the California Consumer Privacy Act ("CCPA"). Personal information provided in the job application process will be collected, used, and retained in accordance with applicable privacy laws. Candidates may request additional information regarding the categories of personal information collected and the purposes for which it is used during the hiring process.

Job DescriptionThe Director of Clinical Operations will provide strategic and operational leadership for our early phase oncology programs. This role will be responsible for end-to-end management of clinical trial activities, ensuring alignment with Janux Therapeutics’ mission to advance innovative oncology therapies. This includes oversight of contract research organizations (CROs), vendors, and clinical sites across both U.S. and international regions. The role will report into the Vice President, Clinical Operations and requires a deep understanding of clinical trial processes, regulatory compliance (GCP, FDA, ICH), and the ability to lead cross-functional teams to ensure high-quality, timely, and cost-effective trial execution.This role offers a unique opportunity to contribute to the development of cutting-edge cancer therapies in a dynamic and mission-driven environment. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Own the operational strategy and execution for early phase oncology program, ensuring all clinical activities support IND-enabling objectives and future clinical development plans., • Lead cross-functional teams (Clinical Development, Regulatory Affairs, Medical Affairs, CMC) to ensure program milestones are met with budget and risks are proactively managed., • Represent Clinical Operations in program-level meetings, regulatory interactions, and external collaborations., • Lead the planning, initiation, execution, and close-out of complex Phase I oncology trials. Ensure all trial activities are conducted in accordance with the protocol, SOPs, GCP, and applicable regulations., • Oversee the development and review of essential study documents (protocols, informed consent forms, CRFs, monitoring plans, study manuals) tailored to IND-enabling requirements., • Manage and oversee external partners including CROs, central labs, safety vendors, eTMF providers, and others. Ensure deliverables are met on time, within budget, and to quality standards. Primary point of contact for vendor issue escalation and resolution., • Participate in site selection, feasibility assessments, and initiation visits. Build strong relationships with vendors, investigators, and site staff to support efficient enrollment and high-quality data collection., • Oversee the development and review of essential study documents such as protocols, informed consent forms, case report forms (CRFs), monitoring plans, and study manuals., • Prepare and deliver study updates, metrics, and presentations to senior leadership. Represent Clinical Operations in internal and external meetings., • Establish and grow the Clinical Operations team over time, fostering a culture of high performance and continuous improvement., • Manage, mentor, and support direct reports, fostering professional development and team performance., • Review monitoring reports and ensure timely resolution of issues. Provide guidance to CRO monitors and ensure appropriate sponsor oversight is documented., • Collaborate with finance and legal teams to manage study budgets, review vendor invoices, and negotiate contracts and change orders., • Work closely with internal stakeholders including Clinical Development, Regulatory Affairs, Medical Affairs, and CMC to ensure alignment and smooth execution of clinical programs., • Contribute to the development and implementation of SOPs, work instructions, and operational plans to enhance team efficiency and compliance., • Perform periodic oversight visits of sites and/or vendors to assess progress and compliance., • Other activities as assigned.REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES, • Bachelor’s degree in life sciences or related field., • Minimum of 10–14 years of total experience in clinical research, including at least 6-8 years in clinical trial management., • Demonstrated experience managing IND-enabling or early-phase oncology trials, particularly in solid tumors, immunotherapy, and/or biologics., • Proven track record of leading trials from start-up through close-out, including protocol development, site initiation, vendor selection/management, and data review., • Strong knowledge of ICH GCP, FDA regulations, and global clinical research guidelines (including EU and APAC)., • Strong IT skills in MS Office and clinical trial systems (e.g., CTMS, eTMF, EDC)., • Ability to interpret and analyze clinical data and metrics., • Excellent communication, leadership, and interpersonal skills, including the ability to understand and present technical information effectively to executive leadership., • Strong organizational and time management abilities., • High level of accountability, adaptability, and attention to detail with an ability to set priorities and handle multiple tasks simultaneously in a changing environment., • Ability to work independently and collaboratively in a fast-paced, matrixed environment., • Ability to travel up to 15%.In addition to a competitive base salary ranging from $205,000 to $235,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.Please note that the hourly rate range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity.Job Type: Full-time Benefits:· 401K· Medical insurance· Dental insurance· Vision insurance· Supplemental disability insurance plans· Flexible schedule· Life insurance· Flexible vacation· Sick time· Incentive stock option plan· Relocation assistance Schedule:· Monday to Friday Work authorization:· United States (Required) Additional Compensation:· Annual targeted bonus % Work Location:· On site (San Diego, CA) EQUAL OPPORTUNITY EMPLOYER:Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. 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 DescriptionDescription: We are seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our team at Kumquat Biosciences. As a CRA, you will play a key role in the coordination and execution of global oncology clinical trials. You will be responsible for ensuring that these trials are conducted in compliance with regulatory guidelines and company protocols. Key Responsibilities: · Support the study lead(s) in day-to-day operational management of one or more clinical trials. · Ensure that investigative sites follow the study protocols, Standard Operating Procedures (SOPs), and regulatory requirements. · May manage one or more key study vendors including central lab, IRT/RTSM, or CRO. · Monitor and track study progress, patient recruitment, and data collection at investigational sites. · Review and verify the accuracy, completeness, and quality of clinical trial data. · Maintain and update essential trial documentation, including case report forms, regulatory documents, and investigator files. · Collaborate with investigators, study coordinators, and other site staff to provide guidance and support. · Identify and escalate any issues or deviations from the study plan to the appropriate parties. · Assist in the preparation and submission of regulatory documents, such as Institutional Review Board (IRB) submissions. · Ensure that the trial is conducted in compliance with Good Clinical Practice (GCP) guidelines and relevant regulations. Requirements: · Bachelor's degree in a related field (Life Sciences, Nursing, etc.), or equivalent experience. · 2+ years of clinical operations experience or related drug development. · Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical research. · Excellent organizational and time-management skills. · Strong communication and interpersonal skills. · Ability to work independently and as part of a cross-functional team. · Proficiency in using Microsoft Office applications, clinical trial management systems, and electronic data capture systems. · Willingness to travel to investigational sites as required. · Familiarity with early phase clinical trial protocols and procedures a plus. · Prior vendor management experience a plus. Salary Description: $93k - $124k Yearly

Job DescriptionThe Senior Director, Biometrics will provide strategic leadership and vision for the Biometrics function, overseeing the design, analysis, and interpretation of clinical and preclinical studies. This role is responsible for setting departmental strategy, driving innovation, and ensuring the highest standards of data integrity and regulatory compliance. The Senior Director will serve as a key advisor to executive leadership and represent the company externally at scientific and industry forums.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Establish and lead a premier Biometrics department, attracting, developing, and retaining top talent in Biostatistics, and Statistical Programming., • Actively engage in the design and analysis of clinical trials and preclinical studies., • Lead cross-functional initiatives to advance clinical development and regulatory success., • Develop and implement statistical analysis plans, including hands-on statistical programming and data analysis as needed., • Collaborates closely with Clinical Development and Operations, Regulatory Affairs, Biomarkers, and Data Management teams to ensure robust study designs and accurate data interpretation., • Foster synergies between functional areas to support the efficient development of high-quality study deliverables., • Provide statistical input and support for regulatory submissions and interactions with health authorities., • Ensures the statistical integrity of protocols, statistical analysis plans, clinical study reports, presentations, and publications of clinical trial data., • Work with internal and external stakeholders in the design, collection, analysis, reporting, interpretation, and publication of clinical trial data., • Set the strategic direction for the Biometrics department, aligning goals with organizational objectives and long-term growth; develop budgets, set priorities, ensure consistency and adherence to standards, and create departmental SOPs., • Drive the development and implementation of new innovations, standards, processes, and programming efficiencies across biometrics., • Maintain a broad understanding of relevant external trends, anticipates emerging issues, identifies strategic needs in technical knowledge, and sets the strategic direction to meet regulatory, scientific, and business needs., • Oversee CRO biometrics deliverables, including but not limited to database and CRF development, statistical analysis plans, and interim and final TLF deliverables, ensuring quality and alignment with organizational goals and objectives., • Represents the organization at professional societies, external scientific forums, and industry-wide technical discussions, as applicable., • Ensure the statistical integrity of all deliverables and compliance with regulatory requirements., • Lead quality assurance initiatives and corrective action planning., • Provide expertise and consultation as a subject matter expert to project teams and serves as a key point of contact with senior management to continuously assess and improve operational project delivery., • Monitor the qualitative and quantitative progress of biometrics implementation activities; oversees study reporting and tracks key indicators for performance and progress evaluation., • Ensure consistent use of study tools, training materials, and compliance with standard processes, policies, and procedures., • Other duties as assigned or deemed necessary by management.EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES, • Ph.D. or Master’s degree in Biostatistics, Statistics, or a related field., • Minimum of 10 years of experience in biostatistics within biotech or pharmaceutical environments, with 5+ years in a senior leadership role., • Demonstrated success in leading biometrics teams through all phases of drug development, including regulatory submissions and health authority interactions., • Strong Phase III statistical planning background., • Proven track record of strategic planning, innovation, and cross-functional leadership., • Expertise in statistical software (e.g., SAS, R), data management tools, EDC platforms, and CDISC standards., • Strong executive presence, communication, and interpersonal skills., • Ability to influence and collaborate at all levels of the organization.In addition to a competitive base salary ranging from $264,000 to $280,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance.Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity.Job Type: Full-time Benefits:· 401K· Medical insurance· Dental insurance· Vision insurance· Supplemental disability insurance plans· Flexible schedule· Life insurance· Flexible vacation· Sick time· Incentive stock option plan· Relocation assistance Schedule:· Monday to Friday Work authorization:· United States (Required) Additional Compensation:· Annual targeted bonus % Work Location:· On site (San Diego, CA) EQUAL OPPORTUNITY EMPLOYER:Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. 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 DescriptionABOUT TRUVIAN Want to work for a fast-paced and disruptive company that is working to revolutionize blood testing? Truvian is a healthcare company at the intersection of diagnostics and consumer tech. We are developing an automated, benchtop diagnostic system to provide lab-accurate results in 30 minutes for a comprehensive suite of health tests. Our proprietary approach, for which we are seeking FDA clearance, is intended to fulfill the promise of delivering accessible and affordable blood testing from one small blood sample, in minutes, in a retail setting or private clinic. To us, our work at Truvian is more than a job – It’s a mission. We are a culture dedicated to discovery and empowerment. We are trailblazers on the path to put health information where it belongs - in the hands of the individual. We are partners in the belief that talented people, working as a team, can make every day an adventure. Come join us as we realize our vision to make routine health testing convenient, affordable, and actionable for today’s connected consumers! JOB SUMMARY Truvian is seeking a strategic and technically adept Director, Clinical Data Management & Data Science build and lead a multidisciplinary team responsible for clinical data strategy, management, analytics, and statistical sciences. This role is pivotal in ensuring data integrity, regulatory compliance, and operational efficiency across the product lifecycle—from early research through regulatory submission and post-market surveillance. This position is ONSITE. The Director will architect and scale Truvian’s clinical data ecosystem — spanning database design, data pipeline integration, clinical data quality, statistical analysis, and data visualization — to support assay validation, regulatory submissions, and real-world evidence generation. The ideal candidate combines strategic leadership with hands-on technical expertise in biostatistics, clinical data systems, and data science for diagnostics. This role requires in-depth expertise in the IVD industry, including knowledge of FDA regulations (21 CFR Part 11, Part 820), and a proven ability to lead data initiatives in a regulated environment. HERE’S WHY YOU WILL LOVE THIS ROLE • Unique Growth Opportunity: Gain hands-on experience across clinical studies, data analysis, regulatory submissions, and product development., • Data-Driven Innovation: Work alongside experienced leaders, contributing to real-world healthcare solutions backed by rigorous data., • Fast-Paced Start-Up Culture: Be part of an agile, mission-driven team where your work has immediate impact., • Professional Development: Receive mentorship and opportunities to expand your technical and industry knowledge., • Meaningful Impact: Help bring innovative diagnostic products to market that can improve patient outcomes., • You love and thrive in a fast-paced and dynamic environment where you can implement fresh ideas, new processes, and make things happen quickly without a bunch of red tape, • You’ll have great perks such as:, • Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K),, • Flexible vacation Strategic Leadership • Develop and execute a unified, robust, and scalable data strategy to support clinical trials, R&D studies, and regulatory submissions., • Build and mentor a high-performing team of data managers, database programmers, biostatisticians, and data scientists., • Serve as a senior advisor to Clinical, R&D, and Regulatory leaders on data architecture, analytics, and evidence strategies., • Ensure alignment of data architecture with business goals and regulatory requirements., • Data Infrastructure and Systems Development, • Lead the design, integration, and governance of clinical databases and data pipelines from the ground up., • Oversee implementation and validation of EDC systems, LIMS, and data warehouse tools to harmonize internal and CRO data sources., • Guide the creation of user-friendly tools for data input, extraction, and analysis across teams., • Establish SOPs, standards, and templates for data collection, cleaning, reconciliation, and database lock., • Direct data management activities for clinical studies, ensuring data quality, completeness, and traceability., • Collaborate with CRO partners and central labs to ensure consistent data flow and integrity., • Biostatistics & Data Science, • Provide strategic direction for statistical design, analysis, and interpretation of clinical and analytical validation studies., • Oversee development of statistical analysis plans (SAPs) and ensure robustness of models and results., • Guide exploratory and confirmatory data analyses, leveraging both traditional biostatistics and modern data science/ML techniques., • Drive the development of data visualization dashboards and analytic tools to support real-time decision-making.Cross-Functional Collaboration, • Partner with Clinical Operations, Regulatory Affairs, Quality, and Product Development teams to ensure alignment of data strategy with business goals., • Support regulatory submissions (FDA, IVDR) through clear, validated, and reproducible data outputs. Required: • Master’s or PhD in Biostatistics, Data Science, Biomedical Informatics, or related quantitative field., • Minimum of 10 years of experience in clinical data management, biostatistics, or data science roles within diagnostics, medical devices, or pharmaceuticals, • Minimum of 5 years of management and leadership experience, • Proven experience building and leading data teams (data management, biostatistics, and informatics) from the ground up in a regulated environment., • Demonstrated ability to design and integrate clinical databases and data pipelines across multiple systems and vendors., • Strong command of SQL and relational databases (e.g., PostgreSQL, MS SQL Server)., • Deep understanding of FDA regulations, including 21 CFR Part 11, Part 820, GCP, ICH E6, and regulatory requirements for IVD data., • Familiarity with EDC systems (Medidata, REDCap, etc.), data visualization tools (Tableau, Spotfire, Power BI), and data standards (CDISC/SDTM, HL7/FHIR)., • An analytical mindset with strong attention to detail and the ability to draw meaningful insights from complex datasets., • Proactive, self-motivated, and eager to take ownership of tasks and learning opportunities., • Exceptional communication skills and ability to translate complex statistical concepts and data into clear, actionable insights for technical and non-technical audiences., • Knowledge of cloud platforms (AWS, Azure) and data governance frameworks., • Startup or small-company experience building infrastructure from scratch, • $196,000 - $216,000 This range encompasses the diverse set of factors considered in making compensation decisions, including, but not limited to, experience, skills, knowledge, abilities, education, licensure, certifications, and other business and organizational needs. Salary offers are determined based on final candidate qualifications and experience. Placement within the compensation range is determined by internal equity and relevant qualifications. HOW TO STAND OUT Interested candidates are encouraged to submit a cover letter along with their resume. The cover letter is an excellent opportunity to share how your experience aligns with our mission, your approach to collaboration, and how your statistical expertise can support innovation in IVD assay development. Equal Opportunity Statement Truvian provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Powered by JazzHR ttdFjrHRVJ

Job Description CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Position Overview: We are seeking a highly qualified Lab Technician/Lab Associate to join our team for a Contract Research Organization (CRO) project focused on clinical lab work and invitro diagnostic (IVD) development. The ideal candidate will have a background in clinical laboratories and at least 3 years of relevant experience in the IVD industry, whether in clinical trials or R&D. The role requires collaboration across disciplines, including regulatory, R&D, and clinical research. You will be involved in various aspects of the project lifecycle, from protocol development to reporting, and must be adaptable to changing duties as the project evolves. Job Type: Full time Job Title: Lab Technician Location: Onsite - San Diego Salary Range: $20.00-$23.00 Key Responsibilities: Perform laboratory procedures and experiments in accordance with clinical protocols. Develop and review clinical study protocols under supervisor guidance. Maintain accurate records of experiments and studies, documenting results and updates. Prepare weekly reports and presentations (PowerPoint) on progress for management and team meetings. Collaborate with R&D, regulatory, and clinical teams to ensure smooth project execution. Communicate effectively with clients and cross-functional teams to prepare materials and testing kits for delivery. Assist with the preparation and shipment of testing kits for clinical sites. Follow Good Laboratory Practices (GLP) and Standard Operating Procedures (SOPs). Engage in regular communication with international colleagues, particularly those in China, and adapt to diverse cultural perspectives. Requirements • Bachelor’s degree in Biochemistry, Chemistry, or a related field is required., • Minimum of 3 years in the IVD industry, either in clinical trials or related R&D roles., • Strong background in clinical laboratory settings, with an understanding of regulatory requirements and protocols., • Excellent communication skills, both written and verbal, with the ability to work well in a team., • Experience with data recording and reporting, including proficiency in creating presentations and briefings for management., • Ability to work in a multidisciplinary environment that includes regulatory, R&D, and clinical research functions. - Familiarity with the IVD product lifecycle and clinical trial processes., • Mandarin (Preferred), • Key Competencies:, • Strong attention to detail and organizational skills., • Adaptability and willingness to take on varied duties as required by project needs., • Ability to work independently and follow procedures while collaborating with a larger global team., • Problem-solving and critical-thinking skills in laboratory and clinical research environments., • Ability to meet deadlines and work efficiently under pressure., • Medical Insurance Plan, • Retirement Plan, • Paid Time Off, • Training & Development We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service

Job DescriptionSalary: $208,000 - $254,000 Job Summary We are seeking a highly motivated Medical Director, Clinical Development to lead the execution of our early-stage clinical programs (Phase III) who will report directly to the VP, Clinical Development. This individual will serve as the primary sponsor representative overseeing outsourced clinical trials run by CRO partners, ensuring scientific integrity, patient safety, and operational excellence. In our entrepreneurial environment, the Medical Director will be both strategic and hands-on, playing a central role in shaping our clinical development path while collaborating closely with internal stakeholders and external experts. The ideal candidate will work in our hybrid office a minimum of 3 days per week. Duties and Responsibilities • Contribute to the design and implementation of clinical development plans, protocols, and study designs in alignment with corporate goals and regulatory expectations., • Draft and review study-related documents including protocols, investigator brochures, IND amendments, and clinical sections of regulatory submissions., • Support the VP, Clinical Development in preparing presentations for executive leadership, board meetings, and scientific/medical forums., • Act as sponsor lead for Phase III trial(s), ensuring compliance with protocol, GCP, and regulatory standards., • Provide day-to-day oversight of study conduct and collaborate with internal cross-functional teams, CROs and other external vendors (eg, clinical operations, regulatory, data management, biostatistics, pharmacovigilance, medical writing)., • Partner with pharmacovigilance providers to ensure accurate, timely safety reporting., • Collaborate with Clinical Development Scientist team to ensure timely review of data listings, safety reports, and interim analyses to support timely, data-driven decisions., • Monitor trial progress and timelines proactively to identify and mitigate risks., • Participate in safety monitoring activities, including clinical review of adverse events, dose-escalation discussions, and safety data reconciliation., • Provide medical/scientific guidance to investigators and clinical sites., • Engage with key opinion leaders (KOLs)and investigators to inform study design and program advancement., • Contribute medical and scientific expertise to publications, abstracts, and presentations. What is Required • M.D. degree, • 3+ years of industry experience in clinical development, with direct involvement in Phase III oncology trials., • Knowledge and experience in solid tumor clinical trials preferred, • Understanding of drug development process, • Demonstrated success working with and managing CROs and vendors., • Experience authoring and reviewing protocols, regulatory documents, and clinical trial submissions preferred., • Knowledge of GCP, ICH guidelines, and U.S. and EU regulatory requirements., • Highly motivated with demonstrated track record of high performance and excellence, • Strong strategic skills including creativity and effectiveness in proactively identifying and addressing challenges, • Strong interpersonal skills and excellent verbal communication and presentation skills., • Well-organized with the ability to be flexible, prioritize multiple demands, and effectively lead in a matrix organization

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical 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 The Associate Director/ Director, Drug Safety will be responsible for maintaining Arrowhead's safety database, preparation and review of regulatory reports such as serious unexpected serious adverse reactions (SUSARs) and periodic aggregate reports in compliance with FDA, EMA and other international guidelines and regulations for clinical programs. This role is base onsite 5x a week at Arrowhead's Research & Development site in San Diego, CA. Responsibilities • Lead Case Processing and support safety medical review, generate appropriate queries to contact drug safety vendors (CROs) to complete and clarify SAE case information as needed and work with CRO to determine when cases are complete and ready to close., • Ensure consistency in investigator causality assessment of SAE reports and source documentation for completeness, accuracy and legibility., • Participate in the standardized set-up of new safety projects, including development of Safety plans and documents, and set-up of safety systems, • Prepare, support and track PVAs/SDEAs with partners., • Monitor compliance with partner Safety related activities needed as per PVA/SDEA., • Create and maintain Safety Management Plans and Reporting documents in collaboration with vendors., • Review vendor scope and assist with study level budgets as needed., • Oversee submission activities for ICSRs and aggregate reports., • Collaborate with vendors for TMF Safety documents filing and review., • Ensure that reported SAE (and events of special interest to include pregnancy and overdose) event reports are received, tracked, evaluated, processed and distributed/submitted in an efficient and timely manner, and in compliance with regulations and Arrowhead Management Plans/SOPs., • Support activities related to implementing and maintaining the Safety Database, supporting ARGUS activities, Overseeing the Safety Vendors, and coordinating the Safety Reporting from Clinical Trials and Collaborators., • Support other members of Safety Operations and Science personnel and ensure flawless execution of Safety and Pharmacovigilance processes, • Facilitate the analysis of similar events for expedited safety reports occurring in pre-marketed clinical studies., • Participate in tracking/monitoring of cases and other vendor or partner deliverables to ensure quality and timeliness of safety management activities, as well as adherence to regulatory and contractual obligations., • Provide drug safety case management support to Safety medical monitors; assist in following up on queries for case reports, abnormal laboratory values, or any other relevant safety and medical data., • Assist with the development and maintenance of departmental SOPs and other procedural documents., • Support reviewing and monitoring of SAE/SUSAR case processing including, performing the secondary quality review for all case reports in the safety, • Support the development and updating of Clinical Risk Management Plans for all clinical Prepare and update study-specific Safety Monitoring Plans as needed, • Help in compiling safety data required for DSC and DSMB meetings for Arrowhead clinical studies, • Monitor SAE reconciliation with the Arrowhead PV vendor and study CRO to ensure the reconciliation process is occurring for all clinical studies, • Liaise with other company departments including, Clinical Operations, Quality, Regulatory, etc., and provide drug safety, • Participate in inspection-readiness activities to included document and eTMF support., • Collaborate with Regulatory personal and CROs to communicate upcoming SAEs requiring expedited submissions to Regulatory Authorities, to include ad hoc reporting responsibilities form Arrowhead Safety., • Support the Manager of Safety Operations and Head of Clinical Safety & Pharmacovigilance in the review and development of written materials including clinical trial protocols, Informed Consent Forms, Case Report Forms, adverse event (AE)/ serious adverse event {SAE) reporting forms, Clinical Study Reports, and Investigator's Brochures (including Reference Safety Information determinations), • Informs Manager of safety related issues and potential trends and or signals arising from review of post-marketed safety data., • Assist with review of cross-functional documents/plans (e.g., protocols, SAE Reconciliation Plans, etc.), • Participate in tracking/monitoring of cases and other vendor or partner deliverables to ensure quality and timeliness of safety management activities, as well as adherence to regulatory and contractual obligations., • Help in managing and updating safety surveillance procedures including signal detection review processes and monitoring abnormal trending of adverse events and laboratory results, • Support monitoring safety surveillance for Arrowhead's clinical development products to ensure corporate compliance with national and international adverse event reporting requirements, • Participate in the production and validation of appropriate safety data output from the external or internal safety database for required safety deliverables (e.g. DSUR, IB, ad hoc analyses etc.)., • Participate in and Help with preparation for regulatory inspections including a compiling of material relating to safety/pharmacovigilance reports and activities, • Responsible for UAT and Implementation of updates within Safety Database., • Assist with periodic Disaster recovery and Business continuity tests as needed with Safety Database., • Support Drug Safety team with listings and data from the Argus database., • MD or DO Degree, • 5-10 years in drug safety operations, pharmacovigilance, and/or a similar combination of education and experience, • Prior experience in Safety/Pharmacovigilance Operations is required., • Strong working knowledge of case management and Experience in using ARGUS or other safety databases. Experience with MedDRA/WHO for coding AEs, medical history, and concomitant medications, • Experience with preparation with aggregate reports, preferably for investigational drugs (i.e., DSURs, IND Annual reports) or post-marketing products (i.e., PSUR/PBRER, PADERs), • Working experience with Safety Databases (Argus, ArisG or other) is required., • Knowledge of ICH E2B guidelines in clinical and post-marketing studies. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job DescriptionDescription: Experienced and professional Manger of Supply Chain who will be responsible for managing the GMP inventory and global logistics at Viking’s San Diego site. The Manager of Clinical Supply Chain will report to the Director of Clinical Supply Chain. The position is highly cross-functional and will work with Quality Control, Quality Assurance, CMC, development team, regulatory, and external vendors. The Sr Manager of Clinical Supply Chain will represent Supply Chain function for Viking to define and operationalize Supply Chain system, to support clinical material manufacturing globally, and to determine distribution strategy for the lifecycle of products from pre-IND through post launch. Essential Duties And Responsibilities The main responsibilities of this role include but are not limited to the following: • With minimal supervision, manage and support investigational drug product supply and logistics activities, including, but not limited to, demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, returns, reconciliation, destruction, cold chain management, and inventory management, • Monitor inventory levels ensuring no shortage of IMP throughout the life of a clinical trial, • Manage of packaging and labeling/distribution vendors, including relationship management, • Manage preparation of clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, coordinating the origination, proofing, and translation of clinical study labels and generation, • Proactively identifying potential issues and developing mitigating actions, • Interpret clinical synopses and protocols to create clinical IMP demand forecasts, • Attend clinical study and cross functional meetings as needed, • Oversee the execution of multiple clinical trials and proactively identify potential supply chain issues and recommend solutions to global supply chain, • Manage clinical study close-out activities, including returned goods, reconciliation, and inventory destruction, • Support drug supply delivery through coordination of CMC efforts (including, but not limited to, CMC, Clinical Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations), • Support temperature excursion processes are executed as required, • Support IRT System development. Lead development of user requirement specifications and management module(s) as applicable, • Various other duties as assigned Requirements: • Bachelor’s degree in Chemistry, Pharmacy or other relevant discipline., • 6+ years of industry experience in Supply Chain Operations., • Significant experience with global shipping and logistics of materials., • Experience working in an FDA-regulated environment is required., • Experience with establishment and maintenance of GMP quality-controlled storage, • Direct experience with importing/exporting documentation (permits, licenses, declaration letters) for global distribution of live virus banks, cell banks, and raw materials., • Direct experience with 3rd party vendors for shipping/logistics service, • Knowledgeable with cGxP as well as regulatory regulations and compliance requirements for the pharmaceutical industry., • Experience in reviewing and authoring SOPs related to CMC Clinical supply chain., • Experience in organizing and management of GMP warehouse inventory, specifically in the biotech/pharma/consumer goods industries., • Experience with Inventory Management Systems is a plus., • Technical working knowledge and/or experience in product packaging or design a plus., • Comfortable in a fast-paced, dynamic, and highly fluid company environment with minimal direction and able to adjust workload based upon changing priorities., • Strong computer skills with Microsoft Office and the ability to quickly learn new applications., • Team player with demonstrated strong communication skills, interpersonal skills, and ability to build effective working relationships throughout all levels of the organization. VIKING THERAPEUTICS Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Notice to Agency and Search Firm Representatives Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Job DescriptionAbout Us Modena Health ("MH") and Modena Allergy & Asthma ("MAA") are leading and rapidly growing medical practices specializing in allergy, asthma, and immunology care, with clinics across Southern California and Arizona—and ambitious plans for national expansion. We are physician-led, hospitality-focused, and technology-enabled, committed to transforming allergy care while advancing clinical research and expanding access to cutting-edge medicine. Known for our high standard of excellence, we provide compassionate, patient-centered care for both pediatric and adult patients. Our model combines hospitality-driven service with innovative technology solutions that streamline operations, improve clinical outcomes, and enhance the experience for both patients and providers. At Modena, we aim to hire great people, treat them well, and help them find meaning and purpose in our mission. Our dedicated team values collaboration, positivity, and growth while striving to improve lives through expert diagnosis, treatment, and research. We are looking for high-energy, kind, and collaborative individuals eager to grow personally and professionally while making a meaningful impact in the lives of others. Position Summary We are seeking a highly skilled and compassionate Allergist/Immunologist Physician to join our growing practice in Greater San Diego, Greater South Bay LA, & New Prospect Locations. As a key member of our healthcare team, you will be responsible for diagnosing and treating patients with a wide range of allergic and immunologic conditions. You will provide high-quality care, collaborate with other medical professionals, and have the opportunity to work in a patient-centered, multidisciplinary environment. The ideal candidate must be a self-motivated and eager individual who will establish him/herself in a practice that enjoys continuous growth. Must have excellent communication skills, bedside manner, and a strong work ethic with a desire to be part of a team that is committed to caring for the whole patient. We place special emphasis on providing patient-centered care, quality outcomes and patient satisfaction. If you are a dedicated and caring Allergist/Immunologist with an interest in advancing the field through clinical research and looking to make a difference in the lives of patients, we encourage you to apply. This is a unique opportunity to shape the future of allergy and immunology care while contributing to groundbreaking research in a collaborative and supportive environment. This role is exempt (salary) and full-time, working 40 hours per week, Monday through Friday with minimal travel. Key Responsibilities • Clinical Responsibilities, • Diagnose, treat, and manage patients with allergies, asthma, immunologic conditions, and related diseases., • Conduct comprehensive patient evaluations, including medical history, physical exams, and appropriate diagnostic tests (e.g., skin tests, blood tests, pulmonary function tests)., • Develop and implement individualized treatment plans, including medication management, immunotherapy, and lifestyle modifications., • Educate patients and their families about managing allergies, asthma, and immunologic conditions., • Perform procedures such as allergy skin testing, spirometry, and immunotherapy (allergy shots)., • Oversee in-office oral food challenges, drug challenges, and immunotherapy treatments (oral immunotherapy and sublingual immunotherapy for environmental and food allergy), • Develop and implement individualized care plans based on patient needs and medical history, including:, • Starting allergy immunotherapy for environmental allergies, • Starting oral immunotherapy for food allergy, • Recommending food or drug challenges as part of allergy evaluation, • Collaborate with other specialists (e.g., pulmonologists, dermatologists, primary care physicians) to ensure comprehensive care for patients., • Maintain accurate and up-to-date medical records in compliance with healthcare regulations and confidentiality standards., • Stay informed about the latest advancements in allergy and immunology treatments and participate in continuing medical education (CME)., • Ensure high patient satisfaction and provide empathetic care, focusing on patient education and wellness., • Additional duties as assigned., • Research Responsibilities, • Engage in clinical research initiatives through Orso Health, Modena Health's research arm, related to the diagnosis, treatment, and prevention of allergic and immunologic diseases, or other areas of clinical interest., • Participate in designing and conducting clinical trials, including trials on new therapies, biologic treatments, and immunotherapy options., • Analyze data, prepare research reports, and collaborate with research teams to publish findings in medical journals., • Contribute to the development of innovative clinical pathways and treatment strategies based on research findings., • Work closely with industry partners, academic institutions, and research foundations to advance clinical studies in allergy and immunology., • Provide mentorship and guidance to junior researchers interested in allergy and immunology research., • Present research findings at national and international conferences., • Additional duties as assigned.Qualifications & Requirements, • Education, • Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO) degree from an accredited medical school., • Experience, • Completion of an accredited residency in Internal Medicine or Pediatrics., • Successful completion of a fellowship in Allergy and Immunology., • Board certified or board eligible in Allergy and Immunology., • 1–3 years of post-fellowship clinical experience preferred; will consider highly qualified new fellowship graduates., • Demonstrated experience in diagnosing and managing patients with allergies, asthma, and immunologic conditions., • Hands-on experience performing and interpreting allergy testing, spirometry, and administering immunotherapy, • Licensure & Certifications, • Board certification or eligibility in Allergy and Immunology (ABAI)., • Valid and unrestricted medical license to practice in California., • Skills & Abilities, • Strong knowledge of allergy, asthma, and immunologic diseases and treatments., • Interest and experience in clinical research, including trial design and data analysis., • Excellent communication and interpersonal skills, with the ability to build rapport with patients and their families., • Ability to work effectively both independently and as part of a collaborative healthcare team., • Compassionate and patient-centered approach to care., • Preferred Qualifications, • Experience in a clinical or private practice setting., • Bilingual in Spanish (preferred but not required)., • Expertise in immunotherapy and biologic treatments for allergy and asthma., • Experience in writing research protocols, grant submissions, or publishing research., • Competitive salary and benefits package, including medical, dental & vision insurance, 401(k) retirement plan with employer matching, and professional development opportunities, • In addition, we offer paid time Off (PTO), sick time, floating holiday and holiday pay, • Opportunity to shape the future of a thriving allergy and asthma practice in beautiful San Diego (and across our expanding network) California Consumer Privacy Act (CCPA) Notice Modena Health ("MH") and Modena Allergy & Asthma ("MAA") complies with the California Consumer Privacy Act ("CCPA"). Personal information provided in the job application process will be collected, used, and retained in accordance with applicable privacy laws. Candidates may request additional information regarding the categories of personal information collected and the purposes for which it is used during the hiring process.

Job DescriptionSalary: About Artiva: Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artivas lead program, AlloNK, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjgrens Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artivas pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cells NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, visit. Position Summary The Clinical Logistics Manager will oversee the end-to-end management of investigational product (IP) and non-IP clinical drug supply forArtivasAlloNK,off-the-shelf (allogeneic) cell therapy clinical programs. This individual will play a key role in ensuringtimelyand compliant delivery of clinical materials to global trial sites, managinglogisticsvendors, andmaintainingrobust site communication. The role requires close collaboration with Clinical Operations, Quality, CMC, Regulatory Affairs,MaterialsManagementand external partners to support the successful execution of cell therapy clinical trials. Key Responsibilities Clinical Supply & Logistics Management • Manage the full lifecycle of investigational product (IP) and non-IP materials, including forecasting, labeling, packaging, distribution, and returns/reconciliation., • Manage inventory of IP and non-IP materials both internally and externally, • Ensure compliance withGxP, IATA, and country-specific regulations governing cell and gene therapylogistics., • Oversee temperature-controlled shipments and chain-of-custody documentation to ensure product integrity., • Serve as the primarylogisticscontact for clinical sitesregardingproduct availability, shipment tracking, and issue resolution., • Provide training and guidance to clinical sites on handling, storage, and return of IP/non-IP materialsas needed., • Manage relationships and performance of third-partylogistics(3PL), packaging, and labeling vendors., • Support vendor qualification, audits, and oversight in collaboration with Quality and Procurementas needed., • Work closely with Manufacturing teamsand Materials Managementto align supply chain activities with production schedules., • Partner with Clinical Operations to ensure seamless coordination between supplylogisticsand trial execution., • Develop and implement process improvements for inventory management, forecasting, and sitelogisticscoordination., • Contribute to the design of digital tools or dashboards for real-time tracking of shipments and inventory. Qualifications and Experience • Bachelors degree in Life Sciences, Supply Chain Management, Pharmacy, or related fieldrequired; advanced degree preferred., • 5+ years of experience in clinical supply chain,logistics, or clinical operations within the biotech or pharmaceutical industry., • Experience managing IP/non-IPlogisticsfor advanced therapy medicinal products (ATMPs) or biologics preferred., • Proventrack recordof vendor management and oversight of global supply chains., • Strong understanding ofGxP, IATA, GDP, and cold-chain management principles., • Excellent project management and organizational skills., • Strong communicationand stakeholder management abilities across cross-functional teams and clinical sites., • Detail-oriented with the ability to troubleshoot and resolve logistical challenges under tight timelines., • Experiencewith clinical supply management systems (IRT/RTSM, ERP, or equivalent). Why you should apply: We have a fantastic team and philosophy! We are passionate we deeply care about our team, our science, and improving the lives of cancer patients. We are tenacious laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients.We are innovative - pushing into new frontiers for patient benefit.We are transparent - believers in flat, accessible, and open communication paths.We are inclusive committed to the diversity of our team and ensuring that all voices are heard. In addition to a great culture, we offer: A beautiful facility An entrepreneurial, highly collaborative, and innovative environment Comprehensive benefits, including: • Medical, Dental, and Vision, • Group Life Insurance, • Long Term Disability (LTD), • 401(k) Retirement Plan, • Employee Assistance Program (EAP), • Flexible Spending Account (FSA), • Paid Time Off (PTO), • Company paid holidays, including the year-end holiday week, • Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey! Base Salary: $115,000 - $130,000. Exact compensation may vary based on skills and experience.

Job DescriptionDescription: At Kumquat, we strive to develop life changing medicines in an efficient and innovative way with the shared mission of patient focus. The Medical Director plays an essential role in leading the development program of a study drug, innovative clinical trial design, execution of clinical studies with the study management team, and data quality to bring better clinical trials to more patients. We want you to join our mission and be part of our passionate and collaborative community, we value individual and team accountability and also see the potential of all our people to learn, grow, develop and achieve great things beyond the confines of traditional descriptions. Job Description: Integral member of a cross functional team for a study drug from the first in human study all the way to registration by: • Developing protocols and protocol amendments for an oncology product, • Work with cross-functional team to develop eCRFs, • Actively participating in study/ site start-up activities, data review and interpretation, site engagement (including SIVs and committees), and provide general medical support to the study team(s), • Maintains up-to-date knowledge on the emerging treatment landscape in study specific areas, • Cultivate meaningful peer-to-peer collaborations and nurture a culture of curiosity to enable faster, simpler, and more patient-centric ways of operationalizing our studies., • Work with colleagues across Kumquat to promote communication and community. Optimizing growth opportunities and capabilities to successfully contribute and operate in a diverse and global environment. Drive new thinking by identifying new opportunities and options to embrace value creation., • Ensure GCP/GVP compliance, data integrity, and take a balanced risk-based approach in the work you are focused on, seeking guidance or direction as needed., • Provide input into work instructions and SOPs to ensure consistency across programs and ensure efficiency, • Author or support authoring of the clinical development plan for the assigned product, • Work closely with medical safety and clinical scientist, medical monitoring of ongoing clinical trial, • You are a talented and passionate human, inspired by our shared purpose to innovate clinical trial delivery to bring better trials to more patients., • You thrive in environments of ambiguity and collaboration where the ability to make sound decisions quickly while seeking advice when needed is essential., • You are an effective communicator that shares information transparently and strategically. You are comfortable working out loud and are an active listener., • You thrive leading or being an active member of large or small diverse teams., • Expectations:, • Knowledge of Clinical development such as study design, protocol execution, medical monitoring, data quality and drug development., • Provides subject matter expertise on activities or through supporting the design and execution of clinical trials and/or enabling projects, • Contributes to the outcome of one or more clinical trials and/or enabling projects., • Understands, applies proficient knowledge of, and ensures adherence to ICH, GCP, and regulatory guidelines within clinical trials or enabling activities., • Builds relationships with sites and investigators and partners to ensure the execution of clinical trials. Requirements: • MD/DO required, • Oncology and or hematology experience as practicing physician preferred, • Minimum of 5 years of relevant experience in the pharmaceutical industry in clinical development, biotech experience preferred., • Phase 1 study trial experience in either solid tumor or hematologic malignancies with a focus on small molecules preferred, • Working knowledge of Drug Development and Clinical development activities and deliverables., • Ability to travel up to 10% of the time domestically or internationally Salary Description: $283k- $357k

Job Description We are partnering with a client on the search for a Head of Biometrics to join their leadership team. Reporting to the Chief Medical Officer (CMO), the Head of Biometrics will provide leadership for driving the company's Biometrics activities for all studies across the world, including management of biostatistics, programming, medical writing, and data management. This leader will shape and influence the entire portfolio and will be responsible for creating vision, leading, developing, and implementing statistical solutions to optimally support all phases of clinical trial and project decision making. The ideal candidate will have proven leadership and communication skills with a drive for delivering innovative bioinformatics-based analysis solutions across a broad range of use cases. This role requires someone with a track record of establishing a strategic roadmap for innovations across bioinformatic methods and algorithms, delivering continuous improvements in core analysis capabilities, establishing an information delivering system, and effectively working with stakeholders. Key Job Responsibilities * Provide leadership and vision for the Biometrics team; responsible for setting, designing, and developing the vision and goals for Biostatistics, Statistical Programming, Data Management, and Medical Writing. Translate strategies and tactical plans into practical and effective actions. * Manage the development of SOPs, statistical programs, and deliverables by CROs for biostatistics, statistical programming, and data management. Collaborate with other functions to ensure data collection and reporting is done in conformance with ongoing practices and regulatory expectations. * Deliver statistically sound scientific methodology experimental design and data analysis input to meet project objectives for global regulatory organizations such as FDA and EMA. Adheres to regulatory guidelines for statistical and clinical data analysis, data structure, and new developments in statistics and drug development. * Author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents, and scientific publications; generates or reviews study randomization and sample size/power estimations. * Liaison for all statistical and operational aspects pertaining to Data Monitoring Committees. * Reports study results of appropriate statistical analyses, in collaboration with clinical development, to provide appropriate interpretation of data and sound study conclusions. * Becomes familiar with the disease states and therapeutic space to enhance the level of collaboration and be able to evaluate implications of study designs. Leadership Attributes * Able to thrive in a fast-paced, dynamic small company environment with ability to adjust workload based upon changing priorities. * Critical thinker with a demonstrated ability to collaborate with both leadership and teams, demonstrating ability to influence, make sound decisions, and drive alignment. * Natural leader with a positive management style, combined with superior communication skills and unwavering ethics and integrity. * Proven interpersonal skills and executive presence, with an effective ability to quickly establish credibility, trust, and support within all levels of the organization. * Leads and reinforces company values and culture in day-to-day behaviors, management style, and expectations. * Self-starter, able to drive work forward within an agile environment with a track record of executing against results. Requirements * A minimum of 15 years of progressive, relevant leadership experience in pharmaceutical or biotechnology clinical trials. Must have early development experience while full-cycle drug development/pharmaceutical experience is highly preferred. * An advanced degree MS or PhD in Statistics, or Biostatistics, or a related field. * Technical knowledge of database structure, and relevant statistical software (e.g., SAS®, East®, and R. programming) background preferable. * Experience with statistical and operational aspects pertaining to Data Monitoring Committees. * Demonstrated agility to learn, and prioritize multiple responsibilities independently, remove barriers and drive projects to completion. * Able to understand and communicate scientific data effectively at all levels and present complex and/or new ideas with clarity and simplicity. Experienced presentation skills tailored to engage and communicate with diverse audiences (investigator meetings, site personnel, KOL interactions and internal project teams).

Assistant, Associate, or Full Professor (HS Clinical, Adjunct, In-Residence, Clinical X) HIV Medicine Clinicians/Infectious Diseases Researcher University of California San Diego Salary range: The posted UC Salary scales set the minimum pay at the appointment as determined by appointment type and, if applicable, rank and/or step. The base pay range for this position is $220,000- $350,000. Salary is negotiated annually. Additional compensation may be available if the position includes membership in the Health Sciences Compensation Plan. UC Salary information can be found here: ___ Application Window Open date: November 19, 2025 Next review date: Sunday, Jan 4, 2026 at 11:59pm (Pacific Time)Apply by this date to ensure full consideration by the committee. Final date: Thursday, Nov 19, 2026 at 11:59pm (Pacific Time)Applications will continue to be accepted until this date, but those received after the review date will only be considered if the position has not yet been filled. Position description The Department of Medicine at the University of California, San Diego (] To apply, please visit: ___

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: * Career development with an international company where you can grow the career you dream of. * Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. * An excellent retirement savings plan with a high employer contribution * Tuition reimbursement, the ___ student debt program, and ___ education benefit - an affordable and convenient path to getting a bachelor’s degree. * A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. * A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity The Clinical Trial Manager works out of our San Diego, CA office location in the Infectious Disease Division in Abbott Rapid Diagnostics. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. What You’ll Work On * Serve as the clinical trial subject matter expert for rapid in vitro diagnostic studies, with a focus on 510(k) OTC and dual 510(k)/CLIA waiver submissions. * Serve as the clinical trial subject matter expert for rapid in vitro diagnostic studies, with a focus on 510(k) OTC and dual 510(k)/CLIA waiver submissions. * Lead the development, review, and finalization of clinical protocols to meet regulatory and scientific objectives. * Manage all aspects of clinical trial operations including study start-up, site initiation, patient enrollment, monitoring, and study close-out. * Oversee clinical site activities, reference laboratories, contract research organizations (CROs), and other external partners to ensure compliance with timelines, budgets, and quality standards. * Supervise and manage electronic data capture (EDC) systems and electronic trial master file (eTMF) platforms to ensure data integrity and regulatory compliance. * Collaborate closely with cross-functional teams including Regulatory Affairs, Quality Assurance, Biostatistics, and Program Management. * Participate in core team meetings to provide clinical insights and contribute to strategic decision-making. * Ensure adherence to Good Clinical Practice (GCP), applicable regulatory requirements, and internal SOPs. * Support regulatory submissions by providing clinical documentation and contributing to responses to regulatory agencies. * Identify and mitigate risks throughout the clinical trial lifecycle. * Mentor and guide junior clinical staff and contribute to continuous process improvement initiatives. Required Qualifications: * Bachelor’s degree in life sciences or related field; advanced degree (e.g., MS, MPH, PhD) preferred. * Minimum of 2 years of experience in clinical trial management, preferably in diagnostics or medical devices. * Strong knowledge of FDA regulations, including 21 CFR Part 812, 50, and 11, and experience with 510(k) and CLIA waiver pathways. * Proven track record in managing multi-site clinical trials and working with CROs and external vendors. * Proficiency with clinical trial systems such as EDC and eTMF. * Excellent organizational, communication, and leadership skills. * Ability to work independently and collaboratively in a fast-paced, cross-functional environment. Preferred Qualifications: * 2 + years of experience with IRB submissions for In vitro diagnostics and regulatory submission pathways for 510(k) OTC and dual 510(k) and CLIA waiver pathways * Minimum of 2 years' experience in conducting clinical research or related scientific laboratory skills. Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ___ Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at ___, on Facebook at ___, and on Twitter @AbbottNews. The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.

Clinical Project Manager - Rare Disease San Diego, CA - On- Site $115,000 - $140,000 A clinical-stage biotech company in San Diego is seeking a Clinical Development Operations Lead to manage global clinical trials and support regulatory strategy across a diverse pipeline. This role is ideal for someone with a strong foundation in clinical research, regulatory coordination, and cross-functional leadership. Key Responsibilities • Clinical Trial Oversight: Lead the planning, execution, and closeout of global clinical studies, ensuring alignment with development and regulatory goals., • Protocol & Site Management: Contribute to protocol design, site selection, and ongoing site relationships., • Regulatory Support: Assist in the preparation of regulatory documents (e.g., INDs, briefing books, investigator brochures) and support health authority interactions., • Cross-Functional Collaboration: Partner with internal teams across clinical operations, data management, medical affairs, and external vendors., • Scientific Contribution: Review clinical data, support interpretation of results, and contribute to publications and presentations., • Process Optimization: Participate in internal process improvement initiatives and mentor junior team members., • Budget & Vendor Management: Develop and manage clinical trial budgets and oversee CROs and other external partners. Qualifications • Advanced degree in life sciences (PharmD, PhD or MS required)., • 5-7 years of clinical experience in biotech or pharmaceutical settings., • Proven track record in IND submissions and regulatory interactions., • Experience in rare diseases, metabolic, CNS, or liver/kidney indications preferred., • Familiarity with RNA-based platforms (siRNA, ASO) is a plus., • Strong project management, communication, and leadership skills., • Ability to work across time zones and manage international teams This role offers the opportunity to contribute to groundbreaking therapies in a dynamic and innovative environment. If you are passionate about clinical operations and making a difference in patients' lives, we encourage you to apply.

Job Description MPF Federal seeks a Quality Assurance Specialist/Quality Control Specialist to support the Naval Health Research Center (NHRC), Operational Infectious Diseases (OID) Directorate. Reporting to the Contract Program Manager and under the mentorship of the Sr. Laboratory Manager, this role oversees the Quality Management System, ensures compliance to regulatory standards, and makes continuous improvements. The NHRC OID is seeking a meticulous and proactive Quality Assurance/Quality Control Specialist to manage and maintain the integrity of critical research regulatory compliance and documentation. This vital role is responsible for ensuring the accurate and secure storage, retrieval, and control of all laboratory records, SOPs, batch records, and other essential documentation related to operational infectious disease research. The QA/QC Specialist will play a key role in supporting quality assurance efforts, maintaining regulatory compliance, and facilitating efficient data management practices. This position requires a strong understanding of quality systems, exceptional attention to detail, and the ability to collaborate effectively with cross-functional teams to ensure the highest standards of data quality and regulatory adherence. The OID Directorate conducts biosurveillance, clinical trials, research, and diagnostic testing to protect our warfighters, their families, and the homeland against infectious diseases and promote global health security. OID maintains a CLIP (Clinical Laboratory Improvement Program) and CAP (College of American Pathologists) accredited laboratory to support all categories of testing. Test specimens are collected and tested in accordance with their respective study protocols, and results are provided to the applicable sponsors, the Armed Forces Health Surveillance Center, local investigators and collaborators, ordering physicians, and county health units to guide proper responses that ultimately affect both the readiness of US forces and the safety of public health. COMPENSATION: $65-70k annually (this is a non-exempt hourly role) Responsibilities · Develops and maintains the Quality Management System (QMS), including the eQMS (MediaLab). · Ensures compliance with applicable regulatory standards (CLIP/CLIA, CAP, FDA, ISO); serves as primary contact for regulatory audits and help prepare and submit necessary documentation and responses. · Oversees and maintains the Internal Audit Program. · Oversees and maintains the Document Control and Record Retention programs, including maintaining a centralized documentation system for all records, ensuring that data and records are securely stored, easily accessible, and meet regulatory and organizational standards. · Oversee and maintain the nonconforming event system, including investigation of complaints, conducting root cause analyses for identified issues, and ensuring corrective and preventative actions (CAPA) are implemented effectively. · Provides training and orientation to new and existing laboratory staff on quality standards, regulatory requirements, and procedures. · Work with management to identify areas for process improvement and implement changes to enhance the quality of laboratory services. · Performs additional duties and responsibilities as assigned or directed by the supervisor, which may include attendance and participation in required training for the role. Requirements Qualifications • A bachelor’s degree in a science-related field., • One or more years of quality assurance experience., • Previous hands-on laboratory bench experience preferred., • Knowledge of Regulations: Strong understanding of CLIA/CLIP/CAP regulations and other relevant federal and state guidelines., • Quality Systems: Expertise in developing and implementing Quality Management Systems., • Auditing Skills: Experience in conducting internal and external audits., • Analytical Skills: Ability to analyze data, identify trends, and conduct root cause analyses., • Communication Skills: Effective communication for reporting findings, training staff, and collaborating with teams and management., • Attention to Detail: Meticulous approach to documentation, data review, and process monitoring., • Ability to work effectively with cross-functional teams, including researchers, laboratory staff, and auditors., • QA/QC Specialist to be able to help with any standardization of clinical trials documentations and SOPs if needed., • US Citizenship and the ability to obtain and maintain a T3/Secret Clearance. Some positions or sites may require that the incumbent be fully vaccinated against COVID-19, and proof of vaccination may be required. Benefits MPF Federal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We offer a competitive compensation package including a competitive salary, medical benefits, PTO, holiday pay and more.

Job DescriptionThe Director of Pharmacovigilance will lead all safety-related activities across Janux’s clinical development programs. This individual will ensure the safety of patients participating in clinical trials and the integrity of Janux’s safety data. This role combines strategic leadership with hands-on execution, ensuring compliance with global regulatory requirements and the proactive integration of safety into drug development. The Director will also serve as a key liaison with regulatory authorities and internal stakeholders, driving a culture of safety and continuous improvement.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: • Develop and execute pharmacovigilance strategies in alignment with Janux’s clinical and regulatory goals., • Represent Janux in safety-related interactions with global health authorities (e.g., FDA, EMA, APAC)., • Lead the development and implementation of safety management plans, risk management plans (RMPs), and signal detection strategies., • Ensure safety is proactively integrated into clinical development and decision-making processes., • Oversee the collection, evaluation, and reporting of adverse events (AEs) and serious adverse events (SAEs) from clinical trials., • Manage external PV vendors and ensure timely, high-quality execution of contracted activities., • Maintain a central repository and program plan for all PV activities and deliverables., • Ensure readiness and execution of safety procedures in response to emerging safety concerns., • Author and review PV-related documents including DSURs, SMPs, RMPs, RSIs, and safety sections of clinical protocols and study reports., • Ensure compliance with global PV regulations (FDA, EMA, APAC, ICH, GVP) and internal SOPs., • Monitor and ensure adherence to PV agreements and safety data exchange agreements (SDEAs) with partners., • Support internal audits and regulatory inspections; conduct root cause analyses and implement CAPAs as needed., • Serve as the safety representative in cross-functional teams, including clinical, regulatory, and medical affairs., • Educate internal teams on evolving safety regulations and best practices., • Lead or contribute to internal safety review meetings, DSMBs, and safety advisory committees., • Other duties as deemed necessaryEDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES, • Graduate-level degree in life sciences, RN, or equivalent health-related training; MD or PharmD preferred., • 8+ years of pharmacovigilance experience in the biotech or pharmaceutical industry, including proven leadership roles., • Strong knowledge of global PV regulations (FDA, EMA, APAC, ICH, GVP)., • Experience in signal management, safety data interpretation, and regulatory reporting., • Oncology and autoimmune experience will be prioritized in this role., • MPH or pharmacoepidemiology training desirable., • Demonstrated ability to lead cross-functional safety initiatives and influence decision-making., • Excellent communication, analytical, and organizational skills., • Proficiency in safety databases (e.g., Argus, ARISg) and MedDRA coding. Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. 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 Overview Elite Clinical Network (ECN) is seeking a dedicated and research-oriented Physician Endocrinologist to join our expanding team of clinical professionals. The ideal candidate will play a critical role in the conduct of clinical trials by serving as a Principal Investigator (PI) or Sub-Investigator, while continuing to provide high-quality medical care to adult patients within a clinical research setting. This is a part time/per diem position with a unique opportunity to contribute to the advancement of medicine through clinical studies. Key Responsibilities • Serve as Principal Investigator or Sub-Investigator on multiple Phase I–IV clinical trials., • Perform comprehensive physical exams and clinical assessments for protocol screening and enrollment., • Evaluate patient eligibility based on inclusion/exclusion criteria of clinical protocols., • Provide medical oversight for clinical trial participants, including safety assessments, adverse event evaluations, and ongoing care., • Collaborate closely with Clinical Research Coordinators, Sponsors, and Monitors to ensure protocol compliance and data integrity., • Review and sign off on source documents, case report forms (CRFs), and regulatory documentation., • Maintain detailed and accurate clinical trial documentation in compliance with ICH-GCP, FDA, and sponsor requirements., • Participate in Site Initiation Visits (SIVs), Monitoring Visits, and Audits as needed., • Manage chronic and acute conditions among study participants in alignment with standard care and protocol guidelines., • Educate and counsel patients on study procedures, informed consent, and potential side effects., • Support recruitment efforts and promote patient retention in trials. Qualifications • MD or DO degree from an accredited medical school., • Valid, unrestricted medical license in the state of employment., • Board Certified or Board Eligible (BC/BE) in Endocrinology., • BC/BE in Family Medicine or Geriatric Medicine will also be considered., • Current Good Clinical Practice (GCP) certification or willingness to obtain prior to start., • Minimum of 1 year of experience in clinical practice; prior clinical research experience preferred but not required. Preferred Skills • Familiarity with FDA, ICH-GCP, and clinical trial protocols., • Experience managing or participating in industry-sponsored clinical trials., • Strong attention to detail and ability to document accurately., • Excellent interpersonal and communication skills for patient interaction and sponsor collaboration., • Ability to work collaboratively with a cross-functional team in a fast-paced research environment., • Comfortable using electronic medical records (EMRs) and clinical trial management systems (CTMS)., • DEA license (preferred).

Job Description MPF Federal seeks a Clinical Research Coordinator I to support the Naval Health Research Center (NHRC). Compensation: $68,000-$71,000 annually Primary Responsibilities • Patient Recruitment and Consent: Identifies, and obtains informed consent from potential study participants in compliance with study protocols and ethical guidelines., • Help lead recruitment efforts, developing and refining strategies to meet enrollment targets., • Make independent decisions about how to target and select participants, and whether a potential participant meets eligibility criteria., • Manage and coordinate complex biosurveillance., • Study Protocol Design and Oversight: Interprets study protocols, assessing feasibility, and modifying procedures to align with the objectives of clinical trials., • Study Visits: Coordinates and conducts study visits, including patient interviews, sample collection, and other protocol-driven procedures., • Data Collection and Entry: Accurately collects, records, and manages study data. Ensures timely data entry into the Clinical Trial Management System (CTMS)., • Data Analysis and Reporting: Interprets data to make recommendations on the direction of the research and adjusts study parameters based on preliminary findings., • Query Resolution: Works with the study team to resolve data queries and discrepancies in accordance with Good Clinical Practice (GCP) guidelines., • Compliance and Regulatory Decisions: Interprets and applies regulatory requirements, ensuring trials comply with legal, ethical, and institutional standards, and addressing issues without minimal supervision by the Clinical Program Manager. Regulatory Management • Assists with Institutional Review Board (IRB) submissions and protocol amendments., • Collaborate with principal investigators and sponsors and provide insights based on field experience., • Recommend changes to improve study feasibility and evaluate the implications of protocol adjustments on ongoing activities., • Ensures compliance with all regulatory requirements, including study registrations in the electronic IRB (eIRB) system. Compliance and Monitoring • Maintains accurate study documentation and ensures that study protocols are adhered to throughout the study lifecycle., • Ensure that the research team follows procedures. Troubleshoot and resolve any deviations or challenges that may arise., • Develop and implement quality control procedures, identify areas for improvement, and resolve any issues that could impact the validity or integrity of the study outcomes., • Prepares for and participates in monitoring visits, audits, and inspections by regulatory agencies. Regulatory Responsibilities • Prepares and submits initial and continuing IRB applications, study amendments, and adverse event reports in compliance with NHRC and sponsor requirements., • Ensures all study-related documents are appropriately filed and accessible for audits., • Manages study registrations and updates in the Clinical Trial Management System and eIRB system. Other Responsibilities • May be required to provide oversight and guidance to Assistant Clinical Research Coordinators and other support personnel., • Remote and On-Site Study Leadership:, • Conduct research activities in varied environments, such as on naval ships or other remote sites, which may involve travel., • Coordinate logistics, including equipment and resource allocation, and serve as a research team representative on-site., • Make real-time decisions regarding study operations and troubleshoot unexpected scenarios to ensure study fidelity and safety. Required • A BA/BS in biological sciences, public health, or equivalent OR five (5) plus years of infectious disease Biosurveillance experience., • Familiarity with regulatory requirements for clinical trials, including IRB submissions and reporting processes., • Proficiency in Clinical Trial Management Systems (CTMS) and electronic IRB systems., • Strong organizational, communication, and problem-solving skills., • Ability to work both independently and collaboratively in a research setting., • US Citizenship and the ability to obtain and maintain a T3/Secret Clearance. Preferred • Certification in clinical research (such as CCRC or CCRP). MPF Federal is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status or on the basis of disability. We offer a competitive compensation package including a competitive salary, medical benefits, PTO, holiday pay and more.

Job DescriptionDescription: We are seeking a highly motivated Senior Director / Head of Statistical Programming to establish and lead the programming function in a dynamic biotech environment. This role combines strategic leadership with hands-on technical contribution, supporting early- to late-phase oncology and other therapeutic programs. The successful candidate will oversee programming deliverables for clinical trials and regulatory submissions, manage CROs, and build internal capabilities to enable data-driven decision-making and accelerate drug development. Key Responsibilities Leadership & Strategy • Define and lead the statistical programming vision, strategy, and operating model in a growing biotech setting., • Serve as the functional lead for programming across all studies and development programs., • Provide expert input into protocol design, SAP development, and regulatory strategy. Execution & Delivery • Oversee and contribute to the creation of high-quality analysis datasets (ADaM), TFLs, and SDTM conversions to support clinical study reporting and regulatory submissions., • Act as programming lead for NDA/BLA/MAA deliverables, ensuring compliance with CDISC, ICH, and regulatory standards., • Implement efficient processes, templates, and standards to maximize quality and productivity in a resource-constrained environment., • Proactively troubleshoot and provide technical solutions for complex programming challenges. Collaboration & Oversight • Partner closely with Biostatistics, Data Management, Clinical, and Regulatory teams to ensure alignment and timely delivery., • Manage and oversee CROs/vendors, ensuring deliverables meet quality, cost, and timeline expectations., • Represent statistical programming in cross-functional governance meetings, study teams, and regulatory interactions. Team Building & Mentorship • Recruit, mentor, and develop a small but high-impact programming team., • Foster a culture of collaboration, accountability, and continuous learning., • Provide training, technical guidance, and career development support to staff. Why Join Us • Opportunity to shape and build the statistical programming function in a growing biotech., • High-impact role with direct influence on advancing innovative therapies to patients., • Collaborative, entrepreneurial culture with strong scientific focus., • Competitive compensation, equity participation, and comprehensive benefits. Requirements: • MS/PhD in Statistics, Biostatistics, Computer Science, Mathematics, or related field., • 10+ years of statistical programming experience in the pharmaceutical/biotech industry, with proven experience leading programming support for regulatory submissions., • Strong hands-on programming expertise in SAS; proficiency in R and/or Python highly desirable., • Excellent knowledge of CDISC (SDTM, ADaM), ICH, and regulatory guidance., • Demonstrated success managing CROs and delivering results in a fast-paced, resource-lean biotech environment., • Strong leadership, communication, and problem-solving skills, with ability to influence and collaborate across functions., • Passion for building teams and infrastructure from the ground up. Salary Details $250k - $300k yearly

Job Description Position Overview Elite Clinical Network (ECN) is seeking a dedicated and research-oriented Physician – Internist to join our expanding team of clinical professionals. The ideal candidate will play a critical role in the conduct of clinical trials by serving as a Principal Investigator (PI) or Sub-Investigator, while continuing to provide high-quality medical care to adult patients within a clinical research setting. This is a part time/per diem position with a unique opportunity to contribute to the advancement of medicine through clinical studies. Key Responsibilities • Serve as Principal Investigator or Sub-Investigator on multiple Phase I–IV clinical trials., • Perform comprehensive physical exams and clinical assessments for protocol screening and enrollment., • Evaluate patient eligibility based on inclusion/exclusion criteria of clinical protocols., • Provide medical oversight for clinical trial participants, including safety assessments, adverse event evaluations, and ongoing care., • Collaborate closely with Clinical Research Coordinators, Sponsors, and Monitors to ensure protocol compliance and data integrity., • Review and sign off on source documents, case report forms (CRFs), and regulatory documentation., • Maintain detailed and accurate clinical trial documentation in compliance with ICH-GCP, FDA, and sponsor requirements., • Participate in Site Initiation Visits (SIVs), Monitoring Visits, and Audits as needed., • Manage chronic and acute conditions among study participants in alignment with standard care and protocol guidelines., • Educate and counsel patients on study procedures, informed consent, and potential side effects., • Support recruitment efforts and promote patient retention in trials. Qualifications • MD or DO degree from an accredited medical school., • Valid, unrestricted medical license in the state of employment., • Board Certified or Board Eligible (BC/BE) in Internal Medicine., • BC/BE in Family Medicine or Geriatric Medicine will also be considered., • Current Good Clinical Practice (GCP) certification or willingness to obtain prior to start., • Minimum of 1 year of experience in clinical practice; prior clinical research experience preferred but not required. Preferred Skills • Familiarity with FDA, ICH-GCP, and clinical trial protocols., • Experience managing or participating in industry-sponsored clinical trials., • Strong attention to detail and ability to document accurately., • Excellent interpersonal and communication skills for patient interaction and sponsor collaboration., • Ability to work collaboratively with a cross-functional team in a fast-paced research environment., • Comfortable using electronic medical records (EMRs) and clinical trial management systems (CTMS)., • DEA license (preferred).

Job Description Vivo HealthStaff is recruiting for a Clinical Trials Physician for a Vaccine Trial in the USA. We are seeking an experienced and licensed Pain Management Physician to provide locum tenens coverage at multiple clinic locations across the USA. The ideal candidate is board certified, has a current medical license, and is looking for contract work. Position Details: Specialty: Clinical Trials Start Date: [Flexible Based on Availability] Contract Length: 3-12 months, with extension potential Schedule: 1-2 days per week Call: No call required Practice Setting: Outpatient clinic Locations Available: * Washington DC * San Diego, CA * Denver, CO * San Jose, CA Responsibilities: * Evaluate patients for a vaccine trial * Collaborate with clinic staff and specialists for comprehensive clinical trial * Use EMR for documentation Requirements: * Active and unrestricted Medical License * Active DEA registration * Prior experience in Clinical Trials Compensation & Benefits: Pay Rate: Competitive hourly rate Payment: Weekly direct deposit Insurance: Malpractice insurance provided Support: Dedicated recruiter assistance throughout the assignment Onboarding Process: Expedited credentialing available Assistance with compliance and facility paperwork Orientation provided before the start date About Vivo HealthStaff: Vivo HealthStaff is a locum tenens staffing firm specializing in placing healthcare professionals in temporary and long-term assignments across the United States. We are committed to providing seamless placement experiences for providers and healthcare organizations.

Job DescriptionAbout Capricor Therapeutics Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a cutting-edge biotechnology company focused on the discovery and development of novel therapies for the treatment or prevention of rare diseases. Our lead product candidate, allogeneic Cardiosphere-Derived Cells (CDCs), known as CAP-1002, is being investigated as a treatment for Duchenne muscular dystrophy. Additionally, we are advancing our exosomes platform technology for inflammatory indications and developing a novel vaccination approach against COVID-19. Capricor is undergoing a manufacturing technology transfer to produce CAP-1002 for late-stage clinical trials and establish a commercial-scale process, while also developing manufacturing processes for exosome-based vaccines. Join our expanding team to contribute to transformative therapies that address unmet medical needs. Position Overview The Warehouse Supervisor directly manages warehouse teams and ensures day-to-day operations meet regulatory, quality, and efficiency standards. Reporting to the Warehouse Manager, this role involves overseeing team performance, compliance, process improvements, and coordination across departments in a dynamic GMP environment. The ideal candidate is a highly motivated leader with strong supervisory experience in warehouse and logistics operations, capable of driving results while adapting to business needs in a collaborative biotech setting. Responsibilities * Capable of performing all warehouse activities to support operations as needed. * Manages team scheduling, performance evaluations, and conducts audits to maintain high standards. * Initiates and completes investigations, corrective and preventive actions (CAPAs) to address issues promptly. * Initiates and completes change controls and supports their implementation. * Updates and creates Standard Operating Procedures (SOPs) and work instructions. * Oversees investigations and resolves inventory discrepancies. * Reviews metrics and leads process improvements to enhance efficiency. * Coordinates with internal departments and ensures team training compliance. * Supports multiple warehouses, including being onsite and traveling between sites as required. * Flexible with shifts and hours to support business needs (e.g., first shift, staggered shifts, and future changes for development and expansion projects). * Conducts meetings utilizing Microsoft Teams, Outlook, and collaborates with partners to drive results. * Supports data collection for Key Performance Indicators (KPIs) in warehouse operations. * Performs all tasks as needed when assigned by the Warehouse Manager. Requirements * Education: GED or Diploma required; Associate’s or Bachelor’s degree preferred. * Experience: * 7+ years in warehouse operations, including 2+ years in a supervisory role; equivalent combination of experience considered. * 4+ years with adept understanding of cGMP, cGDP, and ISO 9001 in biotech, pharma, or related fields. * 2-4+ years in supply chain and logistics. * 2-4+ years operating forklift, box trucks, and associated warehouse equipment. * 2-4+ years in shipping cGMP and cold chain shipping experience. * 2-4+ years with DOT 49CFR and IATA regulations. * 2-4+ years managing staff. * Technical Skills: Strong proficiency in ERP systems and compliance documentation. * Competencies: * Drives Results: Demonstrates accountability and achieves goals under challenging conditions. * Collaborates: Builds relationships and works effectively with others. * Plans and Aligns: Strategically prioritizes tasks and anticipates obstacles. * Manages Ambiguity: Maintains composure in uncertainty and adapts quickly. * Courage: Addresses difficult issues with confidence. * Manages Complexity: Analyzes information for sound decisions. Work Environment and Physical Demands * Setting: Primarily warehouse-based with some office activities, focusing on logistics, inventory management, and team oversight in a GMP-compliant facility. * Physical Requirements: Ability to stand or walk for extended periods; frequently lift or move objects up to 50 pounds; operate warehouse equipment such as forklifts and box trucks; use arms, hands, and fingers to handle, feel, or reach; ability to climb, balance, stoop, kneel, or crouch as needed; travel between sites and flexibility with shifts. Why Capricor? Capricor Therapeutics is an industry leader in cell and exosome therapy, pushing boundaries to create innovative treatments that raise the standard of care. Grounded in integrity and driven by science, our team is committed to making a meaningful impact through patient-centered innovation. Join us and be part of a team that’s changing lives—help us shape the future of healthcare. Compensation (USD) * Salary Range: Competitive, commensurate with experience. * Benefits: Comprehensive benefits package, including health insurance, retirement plans, equity awards, and opportunities for professional development. Come Work with Us! At Capricor, we offer a collaborative work environment that supports your professional growth. Join a passionate team committed to transforming the lives of patients and pushing the boundaries of medical science.

Job DescriptionThe Clinical Trial Manager will play a pivotal role in the strategic implementation and execution of clinical trials from study start-up to close-out. This individual will be instrumental in managing and overseeing CROs, study vendors, and clinical trial sites, while partnering with key internal stakeholders to ensure clinical trial deliverables are completed on time, within budget, and in accordance with regulatory requirements, GCP guidelines, and internal SOPs. This position reports directly to the Director of Clinical Operations and serves as an integral member of the Clinical Operations team, contributing to the development of trial strategy, executing initiatives, and ensuring the highest standards in operational delivery. This is a great opportunity to make a meaningful impact in a fast-paced, mission-driven biotech environment.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Lead the successful execution of clinical trials from protocol concept to clinical study reports in support of complex oncology programs., • Ensure inspection readiness by maintaining comprehensive study documentation and files., • Organize and lead study and departmental meetings, including minute-taking and document archiving., • Coordinate clinical trial equipment, supplies, and cross-functional project activities (e.g., Clinical Data Review Meetings)., • Ensure team compliance with study-specific training and perform TMF reviews for completeness., • Support clinical sites in audit and inspection preparation., • Assist with budget management and daily clinical operations, ensuring adherence to SOPs, ICH/GCP, and regulatory requirements., • Monitor subject and site activity/metrics and perform quality checks across study components., • Proactively identify, troubleshoot, and escalate issues impacting deliverables., • Contribute to study set-up activities including protocol/synopsis development, informed consent forms, system configuration (CTMS, IRT), regulatory submissions, and operational documentation., • Collaborate with CROs to ensure timely collection and archiving of TMF documents., • Partner with regulatory affairs on essential document submissions., • Support study close-out activities including TMF and drug reconciliation and CSR readiness., • Foster effective communication and collaboration with study team members, Clinical Trial Managers, and Asset Leads., • Participate in process improvement and quality initiatives related to study execution., • Other duties as deemed necessary.REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES, • Bachelor's degree with at least 5 years of hands-on clinical trial experience, within a pharmaceutical or biotech environment. A combination of CRO and sponsor-side experience will be considered., • Demonstrated experience in oncology trials, including trial set-up, monitoring, and close-out., • Global clinical trial management experience, especially in the EU, highly desirable., • Strong working knowledge of ICH/GCP regulations., • Proficiency with electronic systems such as eTMF, CTMS, EDC, etc., • Ability to work independently and thrive in a collaborative team environment., • Strong critical thinking skills, a sense of urgency, and a proactive problem-solving mindset., • Excellent interpersonal, written, and verbal communication skills., • Proficiency in MS Office and comfort with technology. Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. 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 DescriptionSalary: $75,000.00 - $100,000.00 We are a small, agile pharmaceutical company advancing late-stage small molecule assets in therapeutic areas with significant unmet need. As we prepare for pivotal clinical trials, we are seeking a highly experienced and detail-oriented Clinical Trial Material (CTM) Consultant to provide part-time, contract-based support for clinical supply strategy, execution, and comparator sourcing. The CTM Consultant will support activities related to the planning, sourcing, and management of clinical trial materials for late-stage development programs, including comparator sourcing and coordination with CDMOs, CROs, and depots. This part-time contract role is ideal for someone with deep experience in clinical supply operations who can operate independently and contribute strategic insight while managing hands-on tasks. ESSENTIAL DUTIES AND RESPONSIBILITIES • Develop and execute clinical supply plans for late-stage clinical trials, including forecasting, packaging, labeling, distribution, and return/reconciliation planning, • Identify and manage sourcing of commercial comparators for global clinical trials, including negotiating supply agreements and managing vendors, • Coordinate with internal teams, CDMOs, depots, and CROs to ensure timely availability and delivery of clinical supplies to trial sites, • Provide strategic input on supply chain design, including depot network selection, packaging configurations, and overage estimates, • Monitor inventory levels, expiry, and resupply needs throughout the trial lifecycle, • Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and all applicable regulatory requirements, • Support documentation, including SOPs, supply plans, shipping records, and reconciliation reports JOB QUALIFICATIONS Education, Certifications, Experience • Bachelors degree in a scientific or technical discipline; advanced degree preferred, • Minimum of 8+ years of experience in clinical supply management, preferably within late-stage development, • Proven experience sourcing and managing commercial comparator products for global trials, • Strong knowledge of GMP/GCP and clinical packaging, labeling, and distribution processes, • Experience working with external vendors, CMOs, and third-party logistics providers, • Comfortable operating in a small team and startup environment with limited infrastructure, • Highly organized, proactive, and self-directed with excellent problem-solving skills, • Experience with IRT systems and supply chain forecasting tools is a plus. SPECIAL WORKING CONDITIONS • Hybrid office environment - must be located in San Diego, • Domestic travel up to 10% may be necessary, • Department: Manufacturing, • Reports To: Director, Clinical Supply, • Position Type: Contract (30 hours a week)

Job DescriptionThe Manager, Clinical Contracts will ensure the successful negotiation and ongoing management of site and vendor clinical trial related agreements and serve as the key liaison between Clinical Operations, Legal, Finance and Accounting departments. This role involves but is not limited to generating, reviewing, finalizing and tracking contracts and budgets, and managing cross-functional communication. This individual will be expected to support the clinical team in the planning, execution and control of contracts. The ideal candidate tasks effectively and applies critical thinking to resolve challenges while maintaining clear communication. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Provide comprehensive contract lifecycle management:, • Work closely with Clinical Operations, Legal, Finance, and other internal and external stakeholders to support the timely initiation, contractual term review, negotiation, risk assessment, execution and administration or contracts., • Manage tracking of contracts, amendments and budgets, and provide updates to the project and cross-functional teams., • Serve as point person for contracts with internal and external stakeholders., • Support RFx and Vendor Management activities., • Support internal oversight of site payment management., • Establish contracting SOPs and guidance documents., • Active participation in team meetings for the purpose of expediting contracts to execution., • Build and maintain strong relationships with clinical sites, and vendors., • Facilitate contract actions and processes independently and effectively in a dynamic environment with competing priorities., • Respond promptly and professionally to inquiries from internal team members and external vendors., • Strong analytical and contract administration skills, verbal and written communication skills., • Identify and implement process improvements to enhance efficiency and accountability., • Ensure compliance with SOPs and regulatory guidelines, addressing QA and audit requests as needed.EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES, • Bachelor’s degree required., • 5+ years’ experience in a contract management position within a biotechnology, pharmaceutical, academia or Clinical Research Organization (CRO)., • Clinical Site Budget experience necessary., • Experience within Global Oncology Phase 1-3 clinical trials preferred., • Grant Plan experience a plus., • Good knowledge of ICH-GCP, pharmaceutical related regulations and laws., • Ability to thrive in a fast-paced growing company with minimal direction and ability to adjust to changing priorities. Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. 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 DescriptionDescription: The Director of Clinical Pharmacology will be responsible for developing and executing clinical pharmacology strategies for small molecule assets in the company portfolio. They will provide expertise in characterizing the pharmacokinetics properties, dose optimization strategies, pharmacometrics assessments, investigating drug interaction potential, food-effect, characterizing QT prolongation potential. They will represent the function in cross-functional meetings and collaborations with key stakeholders like Clinical, Research, DMPK, Biometrics, Translational Medicine, Regulatory, and CMC. Responsibilities will include planning and reviewing study designs & analysis plans; analysis & interpretation of PK, PK/PD data. They will also be responsible for authoring and defending the Clinical Pharmacology sections of regulatory filings. Job Responsibilities • Develop and execute clinical pharmacology and pharmacometrics strategies, including dose and schedule determination and dose optimization, to mitigate risks and support development of small molecule candidates from pre-IND and first-in-human testing through all phases of clinical development., • Integrate clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical development, biostats, regulatory, nonclinical and research to support and impact development decisions, • Responsible for protocol design of clinical pharmacology trials, study planning, review, data analysis / interpretation, and reporting of individual studies implemented to support clinical pharmacology components of project plans., • Prepare appropriate documents or sections of clinical protocols, clinical study reports with respect to Clinical Pharmacology studies or data., • Author regulatory documents (IND’s, NDA’s, IB’s, etc.) and respond to regulatory inquiries related to PK/PD, and clinical pharmacology., • Identify and manage consultants and vendors and monitor work with external vendors to ensure compliance with agreed protocols, quality standards and timelines., • Review external data, analysis, interpretation, and reporting of clinical pharmacokinetic and pharmacodynamic data., • Ensure that appropriate PK, PD and PK/PD data analyses (including population PK, PK/PD modeling and simulation) are conducted for each study/program while adhering to timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs. Strong communication skills with the ability to convey pharmacology data to cross functional teams, senior management and external investigators. Prior experience with NDA/BLA/MAA filings is desirable and prior experience with health authority and authoring responses required.

Job DescriptionSalary: About Artiva: Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artivas lead program, AlloNK, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjgrens Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artivas pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cells NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, visit. Job Summary: This position is responsible for cGMP auditing and supplier management activities at Artiva. Duties/Responsibilities: • Perform GMP/GDP audits in accordance with the external and internal audit program., • Support GXP audits (GLP, GCP, GCLP), as necessary., • Perform Drop-In GMP Internal audits., • Create and maintain audit schedules., • Track audit responses to completion., • Oversee and maintain the supplier qualification program., • Support the creation and execution of Quality Agreements with suppliers., • Update databases, prepare metrics, identify and communicate trending and tracking of audits and related supplier management activities., • Support audits by regulatory or state agencies and partners., • Support QA review of Analytical Development and Process Development data and reports, as needed., • Follow applicable regulations, including FDA, ISO, ICH, company policies and procedures., • Support other QA department needs as identified by management. Requirements: • Bachelors degree or a combination of relevant education and applicable job experience, • 5+ years experience in an FDA regulated industry and expert knowledge of CGMP regulations, • Certified Quality Auditor credential is a plus., • Ability to adapt quickly to shifting needs and/or priorities, • Able to interface well with all levels of personnel, • Excellent communications skills, both written and verbal and a high degree of professionalism, • Exceptional attention to detail, • Flexibility to travel Why you should apply: We have a fantastic team and philosophy! We are passionate we deeply care about our team, our science, and improving the lives of patients. We are tenacious laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients.We are innovative - pushing into new frontiers for patient benefit.We are transparent - believers in flat, accessible, and open communication paths.We are inclusive committed to the diversity of our team and ensuring that all voices are heard. In addition to a great culture, we offer: A beautiful facility An entrepreneurial, highly collaborative, and innovative environment Comprehensive benefits, including: • Medical, Dental, and Vision, • Group Life Insurance, • Long Term Disability (LTD), • 401(k) Retirement Plan with match, • Employee Assistance Program (EAP), • Flexible Spending Account (FSA), • Paid Time Off (PTO), • Company paid holidays, including the year-end holiday week Base Salary: $100,000 - 120,000.Exact compensation may vary based on skills and experience.

Job Description About Tr1X Tr1X is a private, clinical-stage biotechnology company focused on developing a novel class of regulatory T cell-based products to cure autoimmune and inflammatory diseases. Founded by industry experts, including the scientists who discovered Type 1 regulatory T (Tr1) cells, the company is developing a pipeline of off-the-shelf allogeneic cell therapies for autoimmune diseases with high unmet medical need. Our TRX cells are designed to mimic the function of naturally occurring Tr1 cells, which work to restore immune tolerance, stopping severe autoimmune and inflammatory disease in its tracks. Tr1X is the first company ever to use an allogeneic engineered Tr1 cell therapy in clinical trials. Tr1X is headquartered in San Diego, CA. For more information, please visit . Position Summary The Vice President, Head of Clinical Operations (VPCO) reports to the Chief Medical Officer (CMO) and serves as a core member of the Management Leadership Team, contributing to company-wide strategic planning and decision-making. The VPCO is a senior executive leader responsible for establishing and advancing the strategic direction, operational integrity and organizational capability of the Clinical Operations function. This role provides both strategic vision and operational accountability across all clinical programs, ensuring alignment with corporate objectives. The VPCO evaluates and optimizes the organizational structure, systems and leadership capacity within Clinical Operations to ensure long-term scalability, efficiency, and compliance. The VPCO oversees the design and execution of all clinical trials, including strategic vendor partnerships, budgetary governance, and collaboration with cross-functional leaders. As a subject matter expert and enterprise leader, the VPCO establishes governance frameworks, performance metrics, and operating standards that ensure scientific rigor, regulatory compliance, and operational excellence across Tr1X programs. This role establishes executive-level oversight to the Clinical Operations function during a period of organizational growth. The VPCO ensures sustainable processes, leadership continuity, and operational excellence while mentoring existing Tr1X Clinical Operations professionals and preparing the department for long-term success. The VPCO acts as the executive sponsor for Clinical Operations initiatives and ensures the function's integration into corporate strategy, long-term portfolio planning, and investor-facing communications. Key Responsibilities • Define and lead the clinical operations strategy in partnership with the CMO and Company leadership., • Oversee the design and execution of clinical trials in alignment with corporate goals, timelines, budgets, regulatory standards and patient safety and quality requirements., • Evaluate organizational capabilities and implement structural or process improvements to enhance scalability and operational efficiency., • Select, negotiate, and manage CROs and other key external partners, ensuring quality, fiscal discipline, and delivery excellence., • Allocate appropriate resources to support clinical program needs for both internal and outsourced activities., • Lead and collaborate with cross-functional colleagues including translational sciences, clinical development, regulatory affairs, manufacturing, project management, quality and others to ensure effective program execution and adherence to regulatory compliance., • Develop and maintain Clinical Operations infrastructure, including SOPs, study processes, databases, and tracking systems., • Build and lead a high-performing Clinical Operations team; set strategic priorities, develop senior leaders, and foster a culture of excellence and accountability., • Develop and oversee the Clinical Operations budget including clinical study budgets, expenditure tracking, cost-effective resource allocation, financial forecasting, and adherence to fiscal responsibility., • Ensure all clinical trials are conducted in accordance with applicable regulatory agencies including FDA, EMA, and ICH requirements., • Serve as a subject matter expert and key representative of Clinical Operations and build strong and highly collaborative relationships with internal and external stakeholders., • Oversee data integrity and reporting to ensure high-quality clinical trial outcomes for interim data read outs, clinical trial reports, publications, and presentations to internal and external stakeholders., • Regularly report key clinical metrics, operational risks, and mitigation strategies to the Executive Leadership Team and Board of Directors., • Drive change management initiatives that strengthen organizational capability and readiness for future growth., • Travel domestically to clinical sites as required, up to 25% time., • Bachelor's degree in life sciences or related field or advanced nursing degree, • Minimum 16 years of related clinical operations experience with 4+ years at VP-level at a biotech or pharma company including executive oversight and leadership of multi-program portfolios., • Proven ability to mentor and develop senior leaders (e.g., Executive Directors, Directors) within a complex, fast-paced biotech environment., • Extensive clinical trial execution and management experience across a broad range of studies, including early-phase clinical trials., • Expansive experience leading, managing and contracting with CROs, clinical sites, clinical vendors and other clinical study-related partners., • Demonstrated experience building clinical operations infrastructure, including SOPs, processes, and inspection readiness., • Advanced knowledge of FSA, ICH, EMA, IRB/IEC and GCP regulatory requirements., • Exceptional strategic and critical thinking and problem-solving skills., • Excellent organizational, interpersonal, and oral and written communication skills., • Ability to multi-task in a fast-paced, entrepreneurial environment and work collaboratively, under pressure, and with a sense of urgency., • Experience with T-cell immunotherapy trials preferred., • Legally authorized to work for any employer in the U.S., • Position is on-site in San Diego, CA Working at Tr1X At Tr1X, our team is united by a singular shared mission: to transform patients' lives through breakthrough science. We are a group of skilled experts driven by urgency, innovation and a collaborative spirit. Our culture thrives on excellence, positivity, persistence and the agility to tackle new challenges head-on. With an unwavering commitment to patients, science and one another, we foster an environment where team members feel engaged, supported and empowered to make a meaningful impact. We envision a world where autoimmune diseases are not just being treated but are cured. Base Pay Range Anticipated: $300,000 - $340,000 Tr1X considers a variety of factors to determine salary such as education, years of experience, time in the position level, training, knowledge, skills, geographic location, and the market value of the position. Compensation and Benefits Tr1X provides a fair and competitive total rewards program that includes base salary; discretionary annual target bonus; incentive stock options; 401(k) retirement plan with company contribution; health and welfare insurance plans for employees (and their families) that include medical, dental, vision, long-term and short-term disability, and life insurance; paid time off (PTO); and paid holidays. Tr1X embraces a diverse, open, and inclusive environment and believes a strong culture connection is key to success. Tr1X is committed to fairness in recruitment, hiring, transfer, promotion or any other employment practice without regard to race, color, citizenship, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, political affiliation, protected veteran status, or any other characteristic protected by law. If you are an individual needing assistance to complete an employment application or would like to request an accommodation, please contact the Human Resources department at . Notice to Employment Agencies The Tr1X talent acquisition program is managed through internal resources, and unsolicited referrals and resumes are not accepted from employment agencies, unless advance written authorization is granted from the human resources department. Tr1X shall not be liable for any fees arising from any unsolicited or unauthorized candidate information received relative to position vacancies.

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 the CMO, the VP Global Pharmacovigilance has overall responsibility for drug safety activities for early and late phase assets, including furthering the development and implementation of the clinical development strategy. The VP will be accountable for overseeing safety and pharmacovigilance across development and expected global launches and, ultimately, post-marketed products. The VP must possess a strong knowledge of global pharmacovigilance regulations, operational efficiencies, information systems, and best industry practices to effectively solve challenges and facilitate PVG compliance. Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States. Essential Duties and Responsibilities: • Provide Safety Science leadership for clinical development programs and program teams and integrate safety science strategy with clinical development., • Represent GPV in communication with health and regulatory authorities., • Represent GPV at independent Data Safety Monitoring Committee meetings., • Provide medical oversight of the GPV function including medical review of all cases., • Provide medical input for maintaining REMS, RMP safety monitoring commitments., • In collaboration with other members of GPV, create and maintain a signal detection process for Erasca's products with a clearly defined signal detection strategy for each asset., • In collaboration with other members of GPV, ensure robust processes are implemented to meet REMS/RMP commitments., • Overall responsibility for development and implementation of QPV, in collaboration with Quality and GPV Systems., • Provide periodic benefit-risk assessment reports for internal use., • Contribute to the preparation of, review, and approve aggregate safety reports required by health authorities., • Serve as SME author, reviewer, and approver for drug-safety related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), product package labeling, Company Core Safety Information, etc)., • Work with external partners to jointly manage cases, safety reporting, and signal detection across global development for molecule candidates., • Manage implementation and/or operation of data analytics and data reporting tools to support drug safety compliance and analysis., • Build and lead highly functioning GPV team including Safety Operations and Safety Science, utilizing internal and external resources., • Develop operating plans and budgets and allocate resources to ensure budgets, schedules, and performance requirements are met., • Assess process, systems, and staffing needs to scale for multiple late-stage trials, including oversight of CROs and vendors., • Develop and maintain relationships across Erasca, particularly in Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs., • Doctor of Medicine or x-US equivalent with industry experience in safety science for oncology clinical development required; PharmD or other relevant clinical degree may be considered., • 12 or more years of experience in the biotechnology or pharmaceutical industry with knowledge of GCP, clinical trial conduct, data interpretation, and safety in clinical development. A mix of large and small company experience highly preferred., • Excellent scientific and clinical and analytical knowledge base, with the ability to assess data and understand safety and medical implications., • In-depth knowledge of clinical research, including FDA and international regulations, clinical study design, and documentation., • Experience with early clinical development required; experience in late-stage clinical development and NDA or BLA submission preferred., • Extensive experience interfacing with US (FDA) and x-US health authorities required. Experience executing clinical trials in China, reporting safety data to China health authorities preferred., • In depth knowledge of Safety Science and Safety Operations disciplines, with exposure to both internally and externally managed safety systems and databases., • Direct management experience with proven ability to effectively lead, coach, mentor, and manage others., • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment., • Effective interpersonal, communication and influencing skills, including excellent writing skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems. 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.