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Job DescriptionCompany Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team: • Competitive compensation for your work, • Generous time off policy, • Opportunity to broaden your horizons by attending popular conferences, • Emphasis on work/life balance, • Collaborative and team-oriented environment, • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatmentsJob Description This location is based in Waltham, MA, but can be remote The (Senior) Medical Director supports the medical business goals and objectives of one of Sobi’s rheumatology products, providing strategic leadership and tactical execution. Essential Responsibilities/Scope of the Job: Including, but not limited to, the following The Medical Director, US Rheumatology Medical Affairs, will provide strategic and scientific medical affairs leadership for a Rheumatology product in development. The Medical Director will help develop and implement the US medical strategy, tactical plans, and HCP engagement plans, and may support a US launch. S/he will partner with field medical to engage and educate health care providers (HCPs), medical organizations, payers, and patient advocacy groups. He/she will represent the overall Medical Science organization on cross-functional initiatives as required. The successful candidate will need strong knowledge of the pharmaceutical and biotech industries, strong communication and analytical skills, and the ability to develop effective cross-functional relationships in a fast-paced environment. Major Responsibilities: • Provide strategic and scientific medical leadership for the rheumatology product in development. Become a disease state and product expert, providing feedback and insights to medical affairs deliverables, and cross-functional partners, including the design and implementation of Medical Affairs plans, • Work closely with the medical field team to develop/enhance KOL and key institution engagement plans, and participate in KOL engagement and development, establishing Sobi Inc as a scientific partner of choice. Help plan and execute advisory boards and educational activities (webinars, medical roundtables, symposium, congress presence), • Partner with the field medical team to identify key resource needs and to collaborate on developing field materials and tactics. Additionally, partner with the team to establish a medical training plan and provide training/education to cross-functional partners., • Develop a US evidence generation strategy to address stakeholder (HCPs, payers, and patients) needs (including product differentiation, health outcomes), collaborating with HEOR and global partners. Oversee any medical affairs-led research initiatives, including US Phase IV clinical programs, Investigator Initiated Study strategy, and post-hoc analyses, to address US needs., • Partner with scientific communications to inform timely communication of key scientific data and its incorporation into field materials, • Collate medical insights in partnership with the field team and share them internally. Analyze insights for adjustment to strategy and tactics, • Develop and foster strong collaborative relationships with internal partners, including Regulatory Affairs, Clinical Operations, Market Access, Medical Information, Pharmacovigilance, Sales, and Marketing, and provide medical insight and product- and disease-state expertise to meet business objectives., • Support the market access team as needed with medical expertise and in discussions/presentations to payers, • Collaborate closely with global medical and clinical colleagues, ensuring the US perspective and insights are incorporated into global initiatives, • Interacts with Key Opinion Leaders, Regulatory Authorities, and other external agencies in support of our products/ therapeutic areas of interest to advance company objectivesQualifications Requirements • Advanced degree (MD, PharmD, or PhD) in life sciences, • 5+ years of Medical Affairs experience in the pharmaceutical/biotech industry, • 3+ years as a Medical Director, • Previous launch experience required, • Proven ability to shape and execute overall medical strategy, • Experience addressing data gaps, developing solutions, and publishing clinical data—including direct involvement in publication strategy development, data analysis, and execution, • Working knowledge of US legal, regulatory, and compliance guidelines, • Comfortable working in dynamic environments; able to “wear many hats” and adapt to evolving needs, • Excellent communication and presentation skills; able to explain complex scientific concepts clearly, • Strategic and analytical mindset with strong scientific and clinical acumen, • Demonstrated leadership and team-building; fosters a positive, inspiring work climate, • Strong partnering skills; effective collaboration with customers, colleagues, and cross-functional teams at all levels, • Results-driven, solution-oriented, and innovative approach, • Cross-functional experience, especially in organizations where collaboration and versatility are valued, • Enthusiastic, passionate, and empathetic; patient focus is essential, • Ability to travel domestically up to 25%, • Rheumatology experience preferred Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as: • A competitive 401(k) match to support your financial future., • Tuition and wellness reimbursements to invest in your personal and professional growth., • A comprehensive medical, dental, and vision package to prioritize your health and well-being., • Additional recognition awards to celebrate your achievements. The base salary range for this role is $224,000-$290,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details. All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease. Why Join Us? We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to irina.conc@sobi.com Know Your Rights

Job Description PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes. RESPONSIBILITIES Responsible for all Data Management tasks from study start-up to database lock for assigned studies. Lead multiple large and complex studies, performing and delegating tasks as appropriate. Effectively interact with sponsors and manage vendors. Mentor junior personnel. Develop SOPs and study-specific procedures. • Develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, add Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures, • Work with DB programmers to design (e)CRFs and edit checks in EDC system for complex studies, • Lead, coordinate, and perform User Acceptance Testing (UAT) tasks for complex studies and modules, • Ensure proper completion of QC and UAT of EDC tools and modules, including database testing, data export testing, and testing of custom programming, • Coordinate with Sponsor and Vendors to ensure efficiency and quality of electronic data receipt, integration, and reconciliation, • Troubleshoot technical issues as appropriate, • Design “smart” listings and study-specific processes for effective data review, query issue and resolution, • Manage queries and trends to ensure data completeness and integrity, • Perform coding of adverse events, medical conditions and medications., • Perform SAE reconciliation, • Lead and perform pre-lock and data lock tasks, • Prepare training materials and user guides for EDC data collection tools, deliver user training, • Participate in client and team meetings as required, providing status updates and advising on best practices as appropriate, • Design, generate, and review status metric reports, identifying and communication trends as needed, • Ensure archiving of study databases and related documents, • Organize and file study documentation, • Provide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones for complex studies, • Provide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changes, • Provide study specific training for team members and end users, as appropriate, • Implement technical solutions, new tools, and resolve complex issues, • Lead large and complex projects, • Lead client and team meetings as required, • Delegate tasks as appropriate, providing mentorship and following through completion, • Interact with sponsors and manage vendors for complex studies, • Assist with identification of project scope changes, • Present at sales and marketing meetings for prospective clients, • Develop SOPs and manuals EDUCATION • Minimum BS in a scientific or health related field or equivalent EXPERIENCE • Minimum 9 years of experience in Clinical Data Management SKILLS • Knowledge of medical terminology and pharmaceutical notation, • Expertise with EDC systems, such as Medidata Rave, InForm, Medrio, • Excellent organizational and time management skills, • Strong collaboration and leadership skills PHYSICAL REQUIREMENTS Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time. The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate’s work experience, education/training background and parity with current employees in the same or similar positions.

Job Description PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes. The Clinical Trial Associate II (CTA II) supports, coordinates, and implements clinical research projects, working with the study team in the initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and SOPs/WPDs. The CTA II will: • With minimal oversight, manage all study start up, maintenance and closeout site management responsibilities, under the supervision of the Clinical Trial Manager, • Lead the maintenance of audit-ready clinical trial documentation and study status: manage and track regulatory documentation, IND Safety Letter distribution, Confidentiality Agreements and Clinical Trial Contracts, as well as other clinical trial documents, • Set-up, implement and maintain the audit-ready eTMF system under guidance of the Clinical Trial Manager, • In collaboration with the Sr. CTA/CTM, develop study specific processes to ensure that necessary study supplies are available at sites as required, coordinating with appropriate vendors as needed (i.e., Case Report Forms, Study Manuals, lab kits, drug supplies, lab supplies, etc.), • With minimal oversight, manage clinical operations site payments, prepare site invoices and supporting documentation, and approve site payment distribution, • With minimal oversight, manage drug supply and non-drug supply study trackers, • May assist with reviewing monitoring visit reports The CTA II will also perform the following CTA responsibilities: • Support the CTM or project manager with study start up and execution, • Act as a second point of contact between team members, vendors and study sites to assist with study conduct, • Follow established clinical study standards and procedures to plan and conduct clinical research studies, • Request, collect and submit site documents, • Review study start up documents and disseminate to the appropriate functional groups (i.e., legal, regulatory), • Coordinate IRB/EC submissions and tracking progress to review and approval, • Track study start-up status, • Support the establishment and maintenance of the study TMF. Prepare master Clinical Study Files and Trial Master Files for archiving and/or transfer to a client, • Set-up and maintain study clinical trial management system (CTMS), • Assist in development of supportive study documents such as informed consent forms, monitoring templates, study subject tracking tools, study drug shipment and monitoring forms, study manuals and training materials, as required for a new clinical study, • Assist with and/or may play a lead role in the development of data collection tools and procedure manuals, • Work with Project Managers/ Clinical Trial Manager to develop status report templates in accordance with client specifications. Assists the Project Managers/ Clinical Trial Manager to compile status report data throughout the course of a study, • Assist with the tracking and compilation of enrollment information from sites, • Participate in tracking and reporting of study data for management reports, • Collate and distribute study related materials, • Collate and assemble study binders (regulatory, pharmacy, laboratory), study reference manuals and study data collection tools, • Support non-drug supply management, • Support clinical operations site payments, prepare site invoices and supporting documentation, • Accompany the CTM or CRA on site monitoring visits, if required, • Will have some site management responsibilities, • Assist with vendor management, • Apply knowledge of company policies and standard practices to resolve problems, • Maintain open communication channels with study sites and members of the study team to ensure proper study progress, • Analyze issues and use judgment to make decisions, • Escalate non-standard problems or issues as may be required, • Contribute to Standard Operating Procedures (SOPs), manuals, forms and templates to support efficient and compliant best practices of the department, • Contribute to thought leadership and knowledge sharing activities, • Lead team trainings, • Continually identify, recommend and implement innovative process ideas and technologies to elevate PROMETRIKA’s core competencies and offerings, • Perform other duties as required EDUCATION • Bachelor’s degree in a scientific or health related field or equivalent, • PMP Certification preferred but not required EXPERIENCE • Minimum of 2 years of experience directly supporting clinical research trials SKILLS • Problem solving abilities, troubleshooting abilities and resourcefulness, • Analytical problem-solving experience, including excellent organizational skills and attention to detail, • Working knowledge of clinical drug development process as well as ICH, GCP guidelines, and US FDA regulations, • Effective communication and interpersonal skills; ability to build relationships internally and externally, • Knowledge seeking personality, interested in continually seeking out new information, techniques and diverse perspectives, • Ability to track many actions and prioritize timely completion, • Cross functional and cross-cultural awareness, someone who seeks out diverse perspectives and considers these perspectives in decisions that are made, • Must possess soft skills and empathy towards others, • Patient centric philosophy towards research is a must, • Familiarity with medical terms, • Demonstrated writing skills to deliver messages effectively so messages are clearly understood, • Demonstrated expertise with PCs and standard Microsoft Office software applications Physical Requirements Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time. The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate’s work experience, education/training background and parity with current employees in the same or similar positions.

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy. Responsibilities: • Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff., • Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned., • Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents., • May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs., • May serve on or chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs)., • Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies., • Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate., • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings., • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions., • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.Qualifications, • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable., • At least 5 years (7 years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent., • Ability to run a complex clinical research program independently., • Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence., • Ability to interact externally and internally to support a global scientific and business strategy., • Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols., • Must possess excellent oral and written English communication skills., • Ability to exercise judgment and address complex problems and create solutions for one or more projects. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job Description JOB TITLE: Medical Director, Oncology Dept: Clinical Development REPORTS TO: Senior Vice President, Head of Clinical Development Location: Boston, MA DATE PREPARED: March 12, 2026 JOB SUMMARY: AVEO Oncology is seeking a highly skilled and experienced Medical Director to join our dynamic team. The successful candidate will have a strong background in oncology, specifically renal cancer, previous experience in early phase development strongly preferred; and a proven track record in managing global clinical trials. This role is pivotal in driving the clinical development of our oncology pipeline and ensuring the successful execution of our clinical programs. PRINCIPAL DUTIES: 1. Leadership skills: · Provide medical and scientific leadership in the design, execution, and interpretation of Phase I clinical studies. · Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and biostatistics, to ensure alignment on clinical strategy and study design. · Ensure clinical trials are conducted in compliance with applicable regulations, guidelines, and company policies. · Oversee clinical aspects of global clinical studies, ensuring consistency and quality across all regions. · Lead interactions with key opinion leaders to align clinical development plans. 1. Medical Monitoring and Safety Oversight: · Serve as the medical monitor for assigned clinical trials, providing ongoing medical oversight and guidance, addressing any issues that arise to ensure timely completion and high-quality data. · Assess and interpret clinical trial data, ensuring accuracy and completeness of safety and efficacy information. · Collaborate with pharmacovigilance teams to monitor and manage adverse events and other safety concerns. 1. Data Analysis and Reporting: · Participate in data analysis, interpretation, and presentation of clinical study results to internal and external stakeholders. · Contribute to the preparation of clinical study reports, regulatory submissions, and scientific publications. · Present clinical data at scientific conferences and advisory boards. 1. Stakeholder Engagement: · Develop and maintain strong relationships with key opinion leaders, investigators, and clinical trial sites. · Represent AVEO Oncology at scientific meetings, conferences, and industry events. REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS): Education: · Medical Doctor (MD) degree is required. Experience: • Minimum of 3-5 years of experience in oncology clinical development, familiarity with Phase I and phase II clinical studies is required. · Demonstrated experience in managing global clinical trials and navigating international regulatory environments. Skills: · Strong clinical and scientific acumen in oncology. · Excellent leadership, communication, and interpersonal skills. · Proven ability to work effectively in a cross-functional, global team environment. · Strong analytical and problem-solving skills with keen attention to detail. Preferred Qualifications: · Experience working within a biotechnology or pharmaceutical company. · Demonstrated ability to drive clinical development strategies and make data-driven decisions. · Prior experience interacting with global regulatory agencies and key opinion leaders. · Experience in renal oncology clinical trials. About AVEO AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description Position Summary: TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced Clinical Quality professional to join our team as Director of Clinical Quality to lead and oversee all aspects of quality assurance for clinical development programs at TScan, ensuring compliance with Good Clinical Practice (GCP), regulatory requirements, and company policies. This role is instrumental in supporting clinical trials, advancing the development of innovative cell therapy products, and maintaining a culture of quality across the organization. The ideal candidate will possess deep expertise in quality assurance within clinical research, a strong understanding of the regulatory landscape for cell and gene therapy, and the ability to collaborate effectively across cross-functional teams. Someone who enjoys a fast-paced, collaborative, and vibrant culture and excels as a team player with a sense of urgency will thrive in this role. Responsibilities: • Strategic Leadership:, • Develop, implement, and oversee the Clinical Quality Management strategy at TScan to ensure alignment with GCP and regulatory requirements (e.g., FDA, EMA, ICH)., • Provide strategic direction for clinical quality initiatives, focusing on risk-based quality management approaches., • Compliance and Oversight:, • Monitor clinical trial activities to ensure adherence to regulatory guidelines, including patient safety, data integrity, and protocol compliance., • Oversee vendor qualification, performance monitoring, and quality agreements with CROs and other clinical vendors., • Oversee the clinical quality audit program to ensure compliance and identify improvement areas., • Lead the preparation, coordination, and management of regulatory inspections, • Quality Assurance Activities:, • Conduct GCP audits, including investigator sites, clinical vendors, and clinical systems such as trial master files, clinical databases, pharmacovigilance, etc., • Identify quality risks and lead cross-functional teams to implement corrective and preventive actions (CAPAs)., • Manage quality events related to clinical trials., • Collaboration and Training:, • Serve as a quality representative on clinical operations teams, ensuring quality considerations are integrated into all stages of clinical development and trial operations., • Develop and deliver GCP training programs for internal staff., • Work closely with the Clinical Operations, Pharmacovigilance and Medical stakeholders to ensure phase appropriate procedures and processes are implemented and quality events are resolved per internal SOP’s, • Continuous Improvement:, • Drive continuous improvement initiatives to enhance clinical quality processes and systems., • Stay current on evolving regulations, industry trends, and best practices in cell and gene therapy. Requirements: • Education:, • Bachelor’s degree in life sciences, biotechnology, or a related field (advanced degree preferred)., • Experience:, • 10+ years of experience in clinical quality assurance, with a strong background in GCP., • Demonstrated experience in cell and gene therapy or advanced biologics is highly preferred., • Proven track record in managing regulatory inspections a plus., • Experience with electronic quality management systems (eQMS)., • Skills and Competencies:, • In-depth knowledge of GCP regulations and guidelines (FDA, EMA, ICH)., • Strong leadership skills, with the ability to work cross functionally and manage external consulting resources., • Excellent problem-solving, analytical, and decision-making abilities., • Exceptional communication and collaboration skills, with experience working in cross-functional teams., • Ability to manage multiple priorities in a fast-paced, dynamic environment. About TScan: TScan Therapeutics is a fully integrated, next-generation TCR-T cell therapy company. Founded in 2018, TScan’s platform was developed by Stephen Elledge, Ph.D., and Tomasz Kula, Ph.D., at Brigham and Women’s Hospital and Harvard Medical School. TScan’s transformative platform enables rapid discovery of TCRs and targets for engineered T cell therapy. This technology is extremely versatile and is applicable across multiple therapeutic areas beyond cancers, including autoimmune disorders and infectious diseases. Do YOU have the anatomy of a TScanner? Our talented, compassionate, and intelligent team is what makes TScan a Top Place to Work (as ranked by The Boston Globe). Our state-of-the-art offices with over 70,000 square feet of premium lab space, including an internal GMP manufacturing suite, are an environment that supports innovation, camaraderie, and professionalism. We are passionate, fun, flexible, and team oriented. Sound like you? Apply today. EEO Statement TScan is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. TScan provides reasonable accommodations to qualified applicants and employees with disabilities. To begin an interactive dialogue with TScan regarding a reasonable accommodation in connection with the hiring process and/or to perform the responsibilities of the position for which the applicant has applied, please contact the recruiter. Pay Range: $217,500 - $230,000 Pay Transparency TScan Therapeutics’ pay ranges are established based on external market data from third-party compensation surveys and our internal benchmarking. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Individual compensation within this range is commensurate with a candidate’s specific qualifications, including education, overall experience, relevant experience, and specific skills. We strive to ensure that compensation is competitive, equitable, and aligned with the value each TScanner brings to the role. Recruitment & Staffing Agencies TScan Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to TScan Therapeutics or its employees is strictly prohibited unless contacted directly by TScan Therapeutics’ internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of TScan Therapeutics, and TScan Therapeutics will not owe any referral or other fees with respect thereto.

Job DescriptionJob Description The Associate Director, Pharmacovigilance Scientist plays a critical role in safety data analyses for assigned investigational and/or marketed product(s) in partnership with the Safety Physician. This individual also serves as a subject matter expert for the PV Sciences group, contributing to strategic initiatives in collaboration with key stakeholders. The Associate Director, Pharmacovigilance Scientist is expected to be equally effective in working collaboratively and independently. She/he will be responsible for leading and/or contributing to activities such as signal management, aggregate reports, RMP development, ad hoc safety query responses, literature surveillance, and safety analyses for regulatory submissions (NDA, MAA, etc.). For investigational products, this role may also encompass contributions to IB/RSIs, ICFs, SMPs, DMC materials, coding reviews, and safety analyses for CSRs, as applicable. The Associate Director, Pharmacovigilance Scientist will also contribute to process improvement initiatives, lead strategic innovations, and manage/mentor others, as opportunities permit. Key Responsibilities Serves as lead PV Scientist for assigned product(s) – 60% • Conducts signal detection, evaluation, and management, including data coordination, analysis, presentation, and documentation, • Leads and manages the planning, preparation, writing, and review of aggregate safety reports (DSURs, PADERs, PBRERs), • Leads and manages the planning, preparation, writing, and review of risk management plans, • Performs literature surveillance, • Prepares materials for safety governance meetings, • Contributes to safety-related regulatory queries, including data coordination and analysis, • Contributes to relevant sections of key documents (IB/RSIs, CCDS/labels, ICF, DMC materials, coding reviews, CSRs, etc., as applicable), • Contributes to safety analyses associated with regulatory filings (e.g., New Drug Applications or Marketing Authorization Applications), • Supports team in proactively maintaining inspection readiness and serves as a subject matter expert in the event of an inspection Other functional and cross-functional initiatives – 25% • Leads strategic innovations (streamlines processes, evaluates implementation of new technology and resources, etc.), • Conducts impact assessments (e.g., updates to regulations, etc.), • Leads process improvement initiatives and consistency of cross-product processes, • Conducts functional trainings and shares knowledge with the team, • Supports deliverables for other products, where needed Management and mentorship – 15% • Manages, mentors, and trains junior members of the team, • Supports individual development of direct reports Other duties and responsibilities as assigned Qualifications Required Qualifications: • Minimum 5-6 years PV experience, including a minimum of 3-4 years in a PV Scientist or similar role, • Advanced degree (PharmD, RN, MD, PhD, MPH, NP, MS), • Demonstrated experience in analysis and interpretation of medical and scientific data, including experience leading signal management activities and the preparation and authoring of aggregate reports in both post-marketing and clinical trials, • Excellent oral and written communication skills, including the ability to effectively communicate key considerations and decision points, • Detail-oriented with ability to think critically, prioritize tasks, and function independently, • Expert knowledge of pharmacovigilance and drug development, including knowledge of applicable clinical trial and post-marketing safety regulations, • Proven track record in preparing and reviewing regulatory safety documents, including NDAs/MAAs and RMPs, • Prior experience serving as an SME in audits and/or inspections Preferred Capabilities: • Demonstrated experience in various therapeutic areas (e.g., oncology, CNS, etc.), • Expert proficiency with pharmacovigilance databases and relevant coding dictionaries, • Expert knowledge/proficiency with Microsoft Office Suite and Argus Safety systems Additional Information Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $162,000 - $223,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location. Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera’s competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable) Benefits: • Competitive salary and annual bonus., • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more., • Generous parental leave and family planning benefits., • Outstanding culture and opportunities for personal and professional growth. Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team! EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

Job Description PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes. RESPONSIBILITIES The Clinical Trial Manager (CTM) works closely with various sponsors, internal team members and vendors as well as clinical study sites to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, study protocol, company goals, and budgets. The CTM will have the following responsibilities as assigned: • Manage the operational aspects of clinical trials (e.g., study management, site monitoring and management, trial master file (TMF) oversight,), • Coordinate and support regulatory submissions and notifications (e.g., IND/CTA amendments, annual reports), as applicable, • Support the management of the ongoing study budget tracking, forecasting, and reconciliation, for Clinical Operations services, • Assist in Development of and manage the study project plan, including timeline, budget, and resources, • Participate in protocol, CRF and strategy development, Clinical Study Report (CSR) preparation, NDA submission, as appropriate, • Prepare metrics and updates for management, as assigned, • Proactively identify potential study issues/risks and recommend/implement solutions, • Prepare and/or review/approve study-related documents (e.g., Clinical Monitoring Plan, Laboratory Manual, Patient Diary, Study Operational Guildelines, Pharmacy Manual, Integrate Quality Risk Management Plan and CRF Completion Guidelines), • Participate in quality risk assessments and develop Key Performance Indicators (KPIs); including identification of quality issues within the study to implement appropriate corrective action plan, • Participate in and facilitate vendor selection process for outsourced activities, • Review and approve vendor invoices and assess financial impact of scope changes, • Provide ongoing oversight of clinical vendor service providers, including performance monitoring, KPI review, issue escalation and corrective active implementation, • Manage clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations, • Ensure inspection readiness for assigned studies, support regulatory authority inspections, internal audits and responses to audit findings in collaboration with Quality Assurance and Regulatory Affairs, • Manage Clinical Trial Associates (CTA) and other study staff, as needed, • Recommend and implement innovative process ideas to impact clinical trials management, • Organize and manage internal team meetings, investigator meetings and other trial-specific meetings, • Collaborate with Pharmacovigilance and Medical Monitoring to ensure timely safety reporting, SAE reconciliation, and operational alignment with safety processes and vendors, • Partner with Data Management and Biostatistics to oversee clinical data quality metrics, support data cleaning activities, and ensure study readiness for database lock, • Develop site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments, • Manage the feasibility, selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function, • Review and identify trends in enrollment and data entry at sites, and identify solutions, • Manage drug supply and non-drug supply needs of the study, • Develop and implement departmental Standard Operating Procedures, as necessary, • Contribute to knowledge sharing and training opportunities within the department and the company, • Contribute to PROMETRIKA Thought Leadership and marketing campaigns (as necessary), • Mentor and trial junior team members and cross-functional team members (as necessary), • Represent Clinical Operations at bid defense and capabilities presentations, • Perform other duties as required EDUCATION • Bachelor’s degree in life sciences, nursing, pharmacy, public health or related field is required, • Master’s degree (e.g., MS, MPH, MBA) or advanced scientific/clinical training is highly valued but not required, • Project Management Professional (PMP)certification is highly valued but not required EXPERIENCE • Minimum of 5 years working in the clinical research/biotech industry with progressive responsibility in clinical trial operations, • Demonstrated experience managing multiple studies, sites and vendors, included blinded study experience, • Hands-on experience with all phase of the project lifecycle include study start-up, maintenance and close-out, • Hands-on experience study and site management, site monitoring oversight, clinical vendor management, clinical trial risk management, TMF management, and regulatory submissions (e.g., CSR, NDA support)., • Experience working in cross-functional teams and direct involvement in protocol and CRF development is highly valued, • Proven track record of ensuring GCP/regulatory/protocol compliance, managing timelines and budgets, leading risk assessments, and implementing CAPAs and KPIs SKILLS • Working knowledge of the clinical drug development process, • Strong knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, • Strong analytical and problem-solving skills, • Written, verbal communication and presentation skills in small and large group settings, • Must possess excellent interpersonal skills, • Mentoring/coaching, • Ability to effectively multi-task and prioritize, • Organizational skills and attention to detail required, • Solid computer skills requirement of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint, • Cross functional and cross-cultural awareness, • Ability to work in a matrix environment. Must have the ability to build and maintain positive relationships with management, peers, and direct reports, • Ability to deal with time demands, incomplete information or unexpected events Physical Requirements Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time. The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate’s work experience, education/training background and parity with current employees in the same or similar positions.

Job Description PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes. RESPONSIBILITIES • Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results, • Provide statistical input for protocol development, study design, and CRF development by actively contributing to study design considerations in internal and client meetings, and providing and discussing sample size scenarios, • Perform sample size calculations and write statistical methodology sections for inclusion in study protocols, • Oversee production and quality control of randomization schedules, statistical analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents, • Design statistical analysis plans and table shells in accordance with study protocols or for integrated efficacy and safety summaries for New Drug Application (NDA) submissions, • Design analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards if applicable, • Develop SAS programs to produce and/or QC statistical tables/figures/data listings, • Perform mapping from raw datasets to CDISC SDTM datasets, • Produce and perform quality control of define.pdf, define.xml and annotated case report forms for SDTM submission, • Develop SAS programs to produce and validate analysis datasets in CDISC ADaM or other formats specified by the sponsor and CDISC SDTM datasets from raw data, • Maintains expertise in state-of-the-art statistical analyses, • Review and/or write the statistical and results sections of clinical study reports, • Review and/or assist in writing publications, • Review case report forms and data validation guidelines to ensure quality and integrity of study data collection, • Manage multiple projects, • Provide statistical input for Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans, and serve as an independent statistician providing data and analysis support for DMC review, • Provide training and guidance to junior level and new staff, • Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical methodology and analysis, • Support proposal development and attend bid defense meetings, • Review Request for Proposal (RFP) and Scope of Work (SOW) documents, • Understand the SOW, budget and task assumptions, and track work completed versus budgeted tasks, • Manage project budget and forecast resources needed for studies, • Additional responsibilities as assigned by supervisor/manager EDUCATION • MS in Biostatistics, Mathematics, Statistics, Public Health or related discipline required, • PhD in Biostatistics, Mathematics, Statistics, Public Health or related discipline preferred EXPERIENCE • Knowledge of SAS statistical computing package is a must, • Knowledge of other database management and statistical software packages is a plus, • 10+ years of experience in statistical analysis of clinical trials data SKILLS • Experience with general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methods, • Proficiency in SAS statistical programming, • Knowledge of other statistical and data management software packages is a plus, • Strong written and oral communication skills, • Knowledge and experience with CDISC data standards and models, • Strong project management and mentoring/leadership skills, • In-depth knowledge of applicable clinical research regulatory requirements; e.g., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, • Ability to effectively manage multiple tasks and projects, • Ability to clearly describe statistical techniques and interpret results Physical Requirements Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time. The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate’s work experience, education/training background and parity with current employees in the same or similar positions.

Job DescriptionDescription: Sr. Director, Regulatory Affairs At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody-driven diseases. Merida Biosciences is seeking an experienced and strategic Senior Director, Regulatory Affairs to lead and execute global regulatory strategies across our development programs. This individual will serve as a key cross-functional leader and regulatory expert, partnering closely with Program Leadership & Management, Clinical Development, Clinical Pharmacology, Clinical Operations, Biostatistics, Pharmacovigilance, CMC, Nonclinical, Quality, and Executive Leadership to advance innovative therapeutics through development and key regulatory milestones. The ideal candidate brings deep regulatory expertise within biotechnology, strong leadership capabilities, and a collaborative, solutions-oriented mindset suited for a fast-paced and innovative environment. This role will have significant visibility across the organization and will play a critical role in shaping regulatory strategy and health authority interactions. Key Responsibilities • Lead the development and execution of global regulatory strategies for assigned development programs from early development through commercialization., • Serve as the regulatory strategy lead for health authority interactions on assigned programs, including FDA and ex-U.S. regulatory agency interactions., • Provide strategic guidance on regulatory pathways, submission strategies, expedited programs, scenario plans, and risk mitigation plans, • Lead the preparation, review, and submission of regulatory documents, including INDs, IND amendments, CTAs, briefing packages, meeting requests, annual reports, and other assigned regulatory applications., • Represent Regulatory Affairs on cross-functional program teams and provide regulatory leadership across Clinical, Nonclinical, CMC, Quality, and Commercial functions., • Drive regulatory timelines and ensure high-quality, compliant submissions aligned with corporate objectives., • Build and maintain strong working relationships with regulatory agencies and external partners for assigned programs, including regulatory CROs, consultants, and alliance or business partners as applicable., • Monitor evolving global regulatory requirements and assess potential impact on assigned development programs to guide business strategy., • Contribute to organizational growth, process improvements, and development of regulatory infrastructure and best practices., • Mentor and support junior regulatory team members as the organization continues to scale.Requirements: Qualifications • Bachelor’s degree required; advanced degree (MS, PharmD, PhD, MD, or equivalent) preferred., • Minimum of 10 years of regulatory affairs experience within biotechnology and/or pharmaceutical industry, with at least 5 years in leadership role(s)., • Strong experience supporting regulatory strategy and submissions across multiple stages of development., • Demonstrated success leading FDA or equivalent Health Authority interactions and major regulatory submissions., • Experience with global clinical trial applications inclusive of China, Europe, and/or Australia preferred., • Experience in rare disease, immunology, nephrology, infectious disease, or related therapeutic areas preferred., • Deep understanding of global regulatory requirements and drug development processes., • Strong communication, leadership, and influencing skills with the ability to work effectively across functions and levels., • Proven ability to thrive in a dynamic, fast-paced biotech environment. Compensation: We understand that compensation is an important part of considering a new opportunity. Our goal is to be transparent so there are no surprises at the end of the process, and you can feel confident that your offer is both fair and equitable. To support that, we’re sharing our hiring range for this role upfront: typically for the Sr. Director level we target $245,000 to $300,000 . The final offer will take into account a number of factors, including your skills, experience, location, market data, and internal equity. Along with a competitive salary, we’re proud to offer a comprehensive benefits package designed to support you both personally and professionally. Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy. Responsibilities • Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff., • Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned., • Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents., • May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs., • May serve on or chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs)., • Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies., • Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate., • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings., • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions., • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.Qualifications, • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable., • At least 5 years (7 years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent., • Ability to run a complex clinical research program independently., • Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence., • Ability to interact externally and internally to support a global scientific and business strategy., • Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols., • Must possess excellent oral and written English communication skills., • Ability to exercise judgment and address complex problems and create solutions for one or more projects. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job Description Who is BlueRock? BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a pioneering engineered cell therapy company. Using our proprietary CELL+GENE™ platform, we are developing a new generation of allogeneic cellular medicines for patients with neurological and ophthalmologic diseases, conditions where current therapies fall far short. We are at an inflection point. With our lead neurology program (bemdaneprocel) advancing in Parkinson’s disease, an active inherited retinal disease program, and a deep pipeline moving toward IND and beyond, we are building the clinical infrastructure to match our scientific ambitions. Cambridge is our Development hub and we’re building a world-class team here. The Opportunity This is a pivotal, highly visible role for a clinician-scientist who wants to do meaningful safety work at the frontier of cell therapy, not just maintain a system, but help build one. Reporting directly to the Chief Medical Officer and embedded within the Development leadership team, the Clinical Safety Physician will serve as BlueRock’s medical safety lead across our clinical portfolio. The title and level (Senior Director or VP) will be calibrated to experience. What matters most is clinical judgment, a collaborative mindset, and the appetite to shape something from the ground up in a lean, science-driven environment. What You’ll Do • Serve as the medical safety lead and subject matter expert across BlueRock’s clinical trial portfolio, providing hands-on safety review and medical oversight of all ongoing studies, • Lead SAE/SUSAR medical assessment, causality determinations, and benefit-risk evaluation in close partnership with Clinical Development and Regulatory Affairs, • Own safety signal detection and management, including aggregate safety review and signal tracking across programs, • Drive preparation and medical review of safety sections for protocols, statistical analysis plans, clinical study reports, IND/CTA submissions, and periodic aggregate reports (DSURs, PBRERs), • Develop and maintain BlueRock’s Core Safety Information and reference safety information, • Oversee safety vendor selection, management, and deliverable quality for PV operations, • Ensure global safety reporting compliance and maintain inspection readiness, • Contribute to the evolution and growth of BlueRock’s Safety and PV organization as the pipeline expands, • Collaborate with our parent company Bayer and be the point of contact for the Safety/Pharmacovigilance team within Bayer, • Oversee safety operations and safety scientists on the BlueRock team What You Bring • MD (or equivalent) required. active clinical training or clinical medicine background highly valued, • Meaningful (5+ years) pharmaceutical/biotech industry experience in drug safety and pharmacovigilance, with direct experience in clinical trial safety operations and medical review, • Strong working knowledge of FDA and EMA safety regulations; familiarity with ICH E2 guidelines and global IND/CTA safety reporting requirements, • Hands-on experience with SAE narratives, medical coding (MedDRA), signal detection, and benefit-risk documentation, • Comfortable operating in a lean, matrixed environment- a builder, not just a maintainer, • Clear, direct communicator with strong written and verbal skills; able to engage credibly with investigators, regulatory authorities, and cross-functional colleagues, • Genuine interest in cell and gene therapy, rare disease, or neuroscience a strong plus Why BlueRock, Why Now Cambridge’s biotech community is one of the most dynamic in the world, and BlueRock occupies a distinctive niche within it: a company with the scientific daring of a startup and the financial backing of a global pharmaceutical enterprise. You’ll work alongside a small, deeply experienced Development team on programs that have no real precedent, allogeneic iPSC-derived cell therapies in Parkinson’s disease, inherited retinal disease, and beyond. This role offers direct access to leadership, meaningful influence over how safety is practiced at a growing cell therapy company, and the opportunity to be part of clinical programs that, if they work, will fundamentally change how we treat neurodegenerative disease. Hybrid or in-person arrangements available, based in Cambridge, MA. 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: About Us At Lumicell, we'll give you the opportunity to harness all that's within you by working in a mission-driven start-up environment with high-performing employees, tackling some of the most important challenges in cancer surgery. We are working to revolutionize the way cancer surgery is performed today, starting with breast cancer. Women in the US have a 1 in 8 lifetime risk of being diagnosed with breast cancer. You will be a part of something groundbreaking as we expand our commercial launch and continue investigations in other cancer indications. The Clinical Safety Specialist is a key operational role responsible for the day-to-day management and oversight of post-market safety activities for acommercial medical devices/fluorescent drug combination product, with supporting responsibilities for investigationaldevice/drugsafety. This position serves as the primary owner of third-party pharmacovigilance vendor oversight, coordinates internal medical and safety review processes, manages the Clinical Endpoint Adjudication Committee (CEAC) for a large prospective post-market safety study,contributes to clinical operations and tasks associated with safety data collection for clinical studies,and supports the accurate integration and reconciliation of safety data across post-market and clinical safety systems. This role requiresa high levelof attention to detail, strong process discipline, and the ability to manage complex safety workflows where data accuracy, traceability, and regulatory compliance are critical.We are looking for a self-starting and collaborative team member. What you will do: • Serve as the operational lead for post-market pharmacovigilance and safety surveillance activities for commercialcombinationproduct., • Ensure post-market adverse events are collected, tracked, assessed, and documentedin accordance withinternal SOPs, applicable regulations, and post-market safety plans., • Act as primary point of contact and operational owner for third-party Pharmacovigilance Service Providers (PVSPs), including oversight of case processing quality, regulatory reporting timelines, and compliance with Client Working Processes and Statements of Work., • Coordinate internal post-market safety and medical review meetings; prepare, quality-check, and distribute safety review materials; and document decisions, rationales, and action items with clear traceability., • Manage all operational aspects of the Clinical Endpoint Adjudication Committee (CEAC),including memberonboarding, training,logistics, adjudication packet preparation, meeting coordination, and documentation of adjudication outcomes., • Ensureadjudicatedendpoints and safety outcomes are accurately captured, reconciled, and reflected in post-market safety datasets, clinical databases, and downstream analyses and reports., • Support clinical study operations associated with post-market safety studies, including coordination with Clinical Operations and Data Management on safety data collection, query resolution, and protocol- and SAP-aligned safety endpoints., • Serve as a safety operations liaison for post-market safety studies, supporting study start-up, ongoing execution, and close-out activities related to safety data workflows., • Act as primary point of contact for third party central laboratoryreceiving and processing samples to support safety evaluations, overseeing contracting and adherence to lab manual processes, • Maintain highly detailed, audit- and inspection-ready documentation for vendor oversight, CEAC operations, safety reviews, and clinical study safety support activities., • Contribute to continuous improvement of post-market safety and clinical safety workflows, templates, and tracking tools, with a strong emphasis on data accuracy, consistency, and attention to detail., • Support FDA inspections, audits, and regulatory inquiries related to post-market safety surveillance, clinical safety oversight, and endpoint adjudication., • Work closely with Medical, Monitor, Clinical Operations, Data Management Regulatory & Standards Framework Activities performed in this role are conducted in alignment with applicable regulatory requirements and recognized standards, including: • 21 CFR Part 4 Combination Products, • 21 CFR Part 803 Medical Device Reporting (MDR), • 21 CFR Part 812 Investigational Device Exemptions (as applicable), • 21 CFR Part 312Investigational New Drug Applications (as applicable), • FDAmandatedpostmarketsurveillance andpostapprovalstudy requirements, including Section 522 studiesand PMRs/PMCs, as applicable, • ISO 14971 Application of risk management to medical devices, • Applicable principles of ICH E6 (Good Clinical Practice), • Applicable principles of ICH E2 for safety data collection and reporting What you will bring: • Bachelors degree in life sciences, nursing, pharmacy, public health, ora relateddiscipline., • 3-5+ years of experience in post-market safety, pharmacovigilance, medical device surveillance,drugsafetyor clinical safety operations., • Demonstrated experience managing or overseeing third-party pharmacovigilance vendors., • Exceptional attention to detail, with a demonstrated ability to manage complex safety data, track issues across systems, andmaintainaccurate, auditable documentation., • Strong written and verbal communication skills, withdemonstratedability to document safety assessments and decisions clearly and precisely., • Demonstrated ability tomanage multiple tasks, prioritizedeliverables,anticipatechallenges, andexecute ongoals as a member of an interdisciplinary team. An outstanding candidate will also possess the below experience: • Advanced degree (MS, MPH, PharmD, RN, or equivalent)., • Experience with large prospective post-market safety studies, registries, or post-approval studies., • Familiarity with clinical trial systems (EDC, CTMS) and safety databases, including safety data reconciliation activities., • Prior experience supporting FDA inspections or audits related to post-market safety or pharmacovigilance. Position Type/Expected Hours of Work: • This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours. Occasional evening and weekend work may be required as job duties demand., • This is a Hybrid position, and the ability to be on-site 3 days a week is required. Lumicell is committed to a diverse and inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values. Lumicell is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Lumicell will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Job DescriptionCompany Description At Sobi, we believe diversity drives innovation and inclusion creates stronger teams. We are committed to building a workplace where everyone feels valued and empowered to contribute. If this role excites you but you’re unsure if you meet every requirement, we encourage you to apply. Your unique perspective and experiences could be exactly what we need. We look forward to hearing from you! At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team: • Competitive compensation for your work, • Generous time off policy, • Opportunity to broaden your horizons by attending popular conferences, • Emphasis on work/life balance, • Collaborative and team-oriented environment, • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatmentsJob Description The Senior Medical Director supports the medical business goals and objectives of one to two Immunology products, providing strategic leadership and tactical execution. This position reports to the Vice President of Immunology North American medical affairs. Essential Responsibilities/Scope of the Job The Senior Medical Director, US Immunology Medical Affairs, will provide strategic and scientific medical affairs leadership for one or two Immunology products. The Senior Medical Director will help develop and implement US medical strategy, tactical plans, and HCP engagement plans, while contributing to life-cycle management for the products. S/he will partner with field medical to engage and educate health care providers (HCPs), medical organizations, patient advocacy groups, and payers (in conjunction with market access). He/she will represent the overall Medical Affairs organization on cross-functional initiatives as required, including liaising with key cross-functional stakeholders globally and in the US. This role currently has one direct report. The successful candidate will need strong knowledge of the pharmaceutical and biotech industries, high scientific acumen, excellent communication and analytical skills, and the ability to develop effective cross-functional relationships in a fast-paced environment. They must bring a collaborative, strategic, and patient-focused approach to their work. Major Responsibilities: • Provide strategic and scientific medical leadership for immunology product(s). Become a disease state and product expert, providing feedback and insights to medical affairs deliverables, and cross-functional partners, including the design and implementation of Medical Affairs plans, • Work closely with the medical field team to develop/enhance KOL and key institution engagement plans and participate in KOL engagement and development, establishing Sobi Inc as a scientific partner of choice. Help plan and execute advisory boards to obtain advice. Create a medical education strategy and drive tactics to increase product and disease state education (webinars, medical roundtables, symposium, congress presence, CME strategy), • Partner with the field medical team to identify key resource needs and to collaborate on developing field materials and tactics. Additionally, partner with the team to establish a medical training plan and provide training/education to cross-functional partners., • Develop US immunology product(s) evidence generation strategy to address stakeholder (HCPs, payers, and patients) needs (including product differentiation, health outcomes), collaborating with HEOR and global partners. Oversee any medical affairs-led research initiatives, including US Phase IV clinical programs, post hoc analyses, and natural history studies, to address US needs. Additionally, the Senior Medical Director will be a key contributor to the global life cycle management-led activities, including programs for future indications, cytokine testing, Investigator-Initiated Study strategy, and overall input into the creation and execution of product evidence generation plans, • Oversee the US products publication strategy and execution, as well as contribute to the global publication plan and publications., • Partner with scientific communications to ensure timely dissemination of key scientific data and its incorporation into field materials and other educational resources., • Design and implement a medical advisory plan, collate medical insights, partner with the field team, and share them internally. Analyze insights for adjustment to strategy and tactics, • Develop and foster strong collaborative relationships with internal partners, including Regulatory Affairs, Clinical Operations, Market Access, Medical Information, Pharmacovigilance, Sales and Marketing, Global product leadership, Global medical affairs, and clinical development, providing strategic medical insight and product/disease-state expertise to meet business objectives., • Support the market access team as needed with medical expertise and in discussions/presentations to payers, • Collaborate closely with global medical and clinical colleagues, ensuring US perspective and insights are incorporated into global initiatives, • Interact with Key Opinion Leaders, Regulatory Authorities, Patient advocacy groups, and other external agencies in support of our products/ therapeutic areas of interest to advance company objectives to improve patient outcomes, • Lead, or help lead, US product medical activities, including the US brand medical team.Qualifications, • Advanced degree (eg MD, PharmD, or PhD) in life sciences, • 10+ years of pharmaceutical/biotech in medical affairs and/or R&D, including prior senior medical affairs director experience, • Previous experience in rare disease or immunology, preferred, • Strong Scientific and clinical acumen, as well as strategic and analytical abilities, to effectively communicate and present complicated scientific concepts, • Experience identifying and developing solutions to data gaps as well as developing, presenting, and publishing clinical data., • Excellent interdepartmental partnering ability, including the ability to effectively work with customers and colleagues, and the ability to work effectively in a cross-functional team environment; the ability to work with people at all levels, • Demonstrated leadership and team-building skills; able to inspire others by fostering a positive climate, • Working knowledge of US-specific legal, regulatory, and compliance regulations and guidelines, • Drive for results with urgency, solution-orientation, and innovation, • Enthusiasm and passion for work, kindness, and empathy, • Patient focus a must! Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as: • A competitive 401(k) match to support your financial future., • Tuition and wellness reimbursements to invest in your personal and professional growth., • A comprehensive medical, dental, and vision package to prioritize your health and well-being., • Additional recognition awards to celebrate your achievements. The base salary range for this role is $260K – $295K. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details. All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease. Why Join Us? We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to irina.conc@sobi.com Know Your Rights

Job DescriptionCategory Manager - Expanded Access Programs (Hybrid)Location: Waltham, MA (Preferred) or Upper Providence, PA Schedule: Hybrid - Onsite 2 days per week Pay Rate: $80-$90/hour Alphanumeric is hiring a Category Manager to work in Waltham, MA with our client of over 20 years, a global biopharmaceutical company committed to improving lives through innovative medicines and scientific advancements. This role will provide operational leadership and oversight for oncology Expanded Access Programs (EAP) and Compassionate Use (CU) programs, ensuring patients have access to investigational therapies while maintaining compliance with regulatory requirements, company policies, and industry standards. Responsibilities: • Partner with internal stakeholders to provide operational leadership for oncology Expanded Access and Compassionate Use programs., • Develop and execute program strategies related to geographic footprint, drug supply, regulatory coordination, physician engagement, safety reporting, and overall program management., • Oversee the selection, onboarding, and management of vendors supporting access programs., • Establish operational processes that ensure rapid and effective responses to physician requests regarding patient access to EAP/CU programs., • Monitor program utilization and provide regular status updates, metrics, and insights to key stakeholders., • Collaborate cross-functionally with Global Medical Affairs, Clinical Operations, Supply Chain, Regulatory Affairs, Pharmacovigilance, Local Operating Companies (LOCs), physicians, and external partners., • Support program planning, implementation, and continuous improvement initiatives., • Ensure all program activities are conducted in compliance with applicable regulations, company policies, and Standard Operating Procedures (SOPs)., • Identify operational risks and implement mitigation strategies to ensure successful program execution., • Build and maintain strong working relationships across internal and external stakeholder groups. Qualifications: • Bachelor's degree in Life Sciences, Business, Healthcare Administration, Supply Chain, or a related field., • Experience supporting Expanded Access Programs (EAP), Compassionate Use Programs (CU), Medical Affairs, Clinical Operations, Patient Access, or related pharmaceutical programs., • Strong project management and operational leadership skills., • Experience managing external vendors and service providers., • Knowledge of pharmaceutical regulatory requirements and compliance standards., • Excellent communication, stakeholder management, and relationship-building skills., • Ability to manage multiple priorities in a fast-paced, highly collaborative environment., • Strong analytical, organizational, and problem-solving abilities. Preferred Qualifications: • Oncology experience within the pharmaceutical or biotechnology industry., • Experience working with global cross-functional teams., • Familiarity with safety reporting, drug supply management, and regulatory coordination processes.

Job Description PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes. RESPONSIBILITIES The Manager, Medical Writing position is responsible for overseeing and participating in the development of high-quality clinical and regulatory documents in support of global drug development programs of PROMETRIKA’s sponsors. This role requires writing and editing of protocols and scientific and clinical reports including summaries from statistical analyses for submission to regulatory agencies or sponsor use, comprehensive literature reviews, abstracts, posters, and other projects requiring skill in written communication. The Manager, Medical Writing will also contribute to departmental leadership, training initiatives, business development efforts and organizational thought leadership: Medical Writing • Manage and supervise junior medical writers and/or external contractors, • Oversee and/or participate in the development/writing of:, • Clinical Development Plans (CDPs), • Clinical study protocols and Clinical Study Reports (CSRs), • Coordinating and integrating writing of other document sections provided by the project statistician, medical monitor, and other team members, • Clinical sections of INDs, NDAs/BLAs and MAAs and other submission documents (e.g., ISS/ISE, Clinical Summaries), • Initial and or updates for Investigator Brochures (IBs) and IMPDs, • Annual reports and DSURs, • Briefing documents for regulatory submissions, • Journal articles, abstracts, and posters in cooperation with statisticical leads, • Ensure documents meet company, client, and regulatory standards, including ICH/GCP guidelines, • Oversee multiple projects simultaneously, ensuring timelines and deliverables are met, • Conduct document review meetings to discuss comments/ edits by PROMETRIKA Team and/ or Sponsor, • Provide cross-functional medical writing support, • Attend client meetings as required, • Assist with tracking and reporting significant changes in scope of work and recommending change of scope orders to management, when appropriate, • Perform other duties as assigned Departmental responsibilities • Develop and update on an ongoing basis medical writing SOPs and training manuals, • Develop and lead Medical Writing departmental initiatives aligned with organizational strategic goals, • Uphold, demonstrate and teach junior team members PROMETRIKA’s Core Competencies, • Develop internal training materials and deliver trainings as in support of PROMETRIKA Technical Training Committee initiatives, • Recruit, develop, mentor and supervise team members as appropriate to meet the service obligations of the department Thought Leadership • Contribute materials and present at internal Lunch and Learns to cross-train and share Medical Writing expertise within our organization, • Proactively contribute to PROMETRIKA’s newsletters, thought leadership blogs, and other publications as appropriate Business Development Support • Collaborate with Client Relations to participate in Medical Writing at bid defense meetings, • Partner with Client Relations on efficient and timely completion of Requests for Information (RFIs) and Requests for Proposals (RFPs) EDUCATION • Bachelor’s Degree in Science is required, • MS or a Ph.D. is preferred EXPERIENCE • A minimum of 10 years experience in biotechnology/pharmaceutical industry, • A minimum of 7 years regulatory writing in biotechnology/ pharmaceutical industry, • Experience managing medical writers or contractors preferred, • Previous experience in developing clinical and regulatory documents, such as protocols, CSRs, IBs, INDs, ISS/ISE, and DSURs. Previous involvement in writing at least one NDA/BLA/ MAA is required, • Previous experience working in a clincial research organization (CRO) is strongly preferred SKILLS • Knowledge of ICH /GCP, FDA, EMA and other regulatory guidance for clinical and regulatory submissions, • Strong command of scientific and medical terminology with the ability to translate complex information into clear, accurate, and regulatory-compliant content, • Excellent written and verbal communication skills, with attention to detail and quality, • Ability to manage multiple projects and competing priorities in a fast-paced environment, • Knowledge of electronic document platforms is desired, • Additional knowledge/experience in other aspects of drug development (e.g., clinical trial monitoring, data management, statistics) is preferred Physical Requirements Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time. The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate’s work experience, education/training background and parity with current employees in the same or similar positions.

Job Description PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes. RESPONSIBILITIES This position has two main areas of responsibilities. The first is to perform project management activities for assigned projects. The second is to be responsible for the operational aspects of the set-up and management of the Data Monitoring Committee activities. The Project Manager will have the following responsibilities as assigned by the Director of Project Management: General Project Management Responsibilities: • Oversee multiple projects simultaneously, • Coordinate project organization, implementation, management, and financial activities for non-DMC projects between all functional areas at PROMETRIKA and with the client using PROMETRIKA’s Project Manual and procedures, as available, • Prepare the project plan including timelines and resource requirements using these tools to measure actual project progress., • Work with PROMETRIKA study team and client to implement solutions to problems with study timelines, schedules, resources, budgets, etc., • Along with internal finance project management, develop, evaluate and manage project budget against project milestones for assigned projects to ensure profitability., • Track and report significant changes in scope of work and recommend change of scope orders to management, when appropriate., • Coordinate project team meetings (prepare agenda and meeting minutes) for assigned projects if stated in the contract., • Prepare project status reports for assigned projects to the client, on a predetermined schedule if stated in the contract., • Participate in all formal interactions with the client on a pre-determined frequency, • Conduct other project management tasks as assigned DMC Project Management Responsibilities: • Serve as primary point of contact to the sponsor regarding assigned DMC projects, • Act as the main point of contact between the DMC members and the sponsor, • Assume primary responsibility for ensuring adherence to the DMC charter by all involved parties. Ensure that all requests made by the sponsor to deviate from the charter are documented in writing, • Assure that project tasks and deliverables are properly executed and tracked according to defined budgets and timelines, • Assist in the development of the DMC data preparation timeline, • Assess the impact of added efficiencies/process improvements introduced specifically for the DMC group within Biostatistics and Programming Department, • Work with the Associate Director, Biostatistics and Leader of DMC Group as well as the Client Relations Department on implementing efficiencies into budgets for bids for new work, • Identify DMC members and manage the process of contract development and execution for DMC members, • Manage payment of honoraria to the DMC members and maintain tracking of payments in accordance with the Sunshine Act if requested by sponsor, • Track pass-through costs, • Ensure that all sponsor and DMC member requests to PROMETRIKA align with the PROMETRIKA Statement of Work with the sponsor, • Poll the DMC members and the Sponsor for potential meeting dates. Bring quorum issues to the attention of the sponsor and facilitate discussions between members and the sponsor to identify a solution, • Track and accommodate DMC member requests as they relate to the meeting, • Set up and host the teleconference/web conference if the meeting is held virtually, or book meeting location and coordinate relevant logistics if the meeting is held in-person. Ensure all details are properly communicated to all relevant parties., • Confirm Data Monitoring Report contents with the sponsor and ensure timely receipt of all materials. Compile all documents for the assembly of the Data Monitoring Report, • Provide the Data Monitoring Report in accordance with the timeline as stipulated in the DMC charter, • Build the tables, listings, and figures (TLF) pdf document and Table of Contents in accordance with the TLF shell as provided by the sponsor, • Develop and QC the meeting agenda and cover letter, • Attend DMC meetings and take minutes of the DMC meetings, • Circulate the draft minutes and recommendation to the appropriate stake holders and finalize the minutes and recommendation in accordance with the DMC charter, • All other coordination tasks as necessary and appropriate DMC Group Infrastructure Responsibilities: • Collaborate with Associate Director, Biostatistics and Leader of DMC Services to develop and maintain documents, tools, and forms, standardizing the formatting of existing templates both in the DMC group and within the wider Biostatistics/Statistical Programming department, • Responsible for first draft of most documents for the DMC group, such as standard TLF shells and report shells, • Coordinate with Quality Assurance and Biostatistics to ensure that SOPs cover DMC work without hindering potential efficiencies and work with management to establish new SOPs where needed, • Other responsibilities as assigned EDUCATION • Bachelor’s degree in Computer Science, Mathematics, Statistics, Life Sciences or a related field is required or equivalent combination of education, skills and experience to perform the job EXPERIENCE • Minimum of 5 years of experience in a clinical project management environment (CRO, pharmaceutical company, or other centralized service provider used in clinical studies), • Minimum of 1 year of experience in the document support role, • Demonstrated experience of successfully managing or leading multidisciplinary teams, • Demonstrated experience with process improvement initiatives SKILLS • Excellent written and verbal communication skills, • Strong organizational skills, especially around scheduling and planning meetings, • Fluent in spoken and written English, • Meticulous attention to detail, • Excellent time management skills, • Advanced skills in MS Office application, particularly Microsoft Word and Excel, • Ability to work independently and know when escalation is necessary, • Ability to handle multiple tasks, including rapid response in generating new documents, forms and tools, • Quick learner, self-reliant and enjoys working within cross functional teams Physical Requirements Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time. The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate’s work experience, education/training background and parity with current employees in the same or similar positions.

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Purpose: Oversees the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy. Responsibilities: • Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff., • Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned., • Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents., • May oversee the work of Medical Directors and/or Scientific Directors, and of Clinical Scientists working on the same or related programs., • Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies., • May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT), ADT Leadership Board (ALB)., • Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate., • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area., • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions., • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.Qualifications, • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable., • At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent., • Ability to run a clinical research program of moderate complexity with minimal supervision., • Ability to perform and bring out the best in others on a cross-functional global team., • Ability to interact externally and internally to support a global scientific and business strategy., • Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols., • Must possess excellent oral and written English communication skills. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job DescriptionSummary The Senior Director of Clinical Operations oversees all aspects of clinical trial execution, including start-up, monitoring, and close-out activities for all ARTBIO programs. This key role leads the clinical operations team and ensures that the company achieves study goals and objectives while maintaining high-quality clinical data and study integrity. The Senior Director of Clinical Operations collaborates closely with cross-functional teams, including clinical development, project management, regulatory, quality, finance, and translational and discovery research, to drive the successful execution of clinical study plans. Main Duties and Responsibilities • Establish clear standards and expectations for the accurate, timely execution of clinical trials and the operations teams supporting them., • Oversee study operational plans and execution from concept through close out and CSR writing, including site and vendor selection, data management, pharmacovigilance operations, imaging and laboratory assessments, and regulatory activities., • Assess and provide input into schedule of activities of study protocols from an operational and feasibility perspective., • Review DSUR, study protocols, annual reports, and IB submissions for accuracy and alignment to compound strategy., • Lead and execute clinical operations strategies and enrollment plans in close collaboration with internal stakeholders, alliance partners, and Clinical Research Organizations (CROs)., • Manage CRO(s) performance to ensure adherence to the scope of work within timelines and budget at an overall study level., • Build out an in-house CRA team for Phase 1 study monitoring., • Work with the existing clinical trial managers and clinical scientists to ensure trial delivery and success., • Collaborate with the manufacturing and logistics teams for alignment on drug product delivery to clinical studies., • Work closely with the CMO to develop the global clinical operations budget with a focus on operational excellence, cost efficiency, and quality., • Proactively assess potential risks to clinical studies and propose mitigation plans.Qualifications & Experience Required, • Bachelor’s, Master's, or higher qualification in life sciences or nursing., • Minimum of 7 years of experience in clinical development, including at least 5 years in clinical operations of Phase 1 or 2 oncology clinical studies, with at least 2 of the years in a clinical trial or project management leadership role., • Remote flexibility with up to 25% travel within the United States.Knowledge, Skills & Abilities Required, • Cross-functional understanding and technical knowledge of drug development processes and clinical trial methodology., • Thorough knowledge and understanding of Good Clinical Practices, ICH Guidelines, and applicable international regulations and guidelines., • Strong project management/organizational skills., • Excellent technical experience with MS applications (e.g., MS Project, Word, Excel)., • Experience with study tools, including CTMS, eTMF, Medidata RAVE, and other EDC systems.About UsChanneling Energy. Changing Lives. ARTBIO redefines cancer care by discovering and developing a new class of Alpha Radioligand Therapies (ARTs), powered by unique Pb-212 isotope technology and seamless supply. Our team works tirelessly to bring therapies that matter to patients who need them. The unique ARTBIO approach selects the optimal alpha-precursor isotope (212Pb) and tumor-specific targets to create therapeutics with the potential for the highest efficacy and safety. The company's AlphaDirect™ technology, a first-of-its-kind 212Pb isolation method, enables a distributed manufacturing approach for the reliable production and delivery of ARTs. ARTBIO is advancing multiple pipeline programs, with lead program AB001 currently in first-in-human trials. The company is shaped by a long-standing scientific legacy with nearly a century of pioneering work in radiation therapy conducted at the University of Oslo and Norway’s Radium Hospital. Cancer is relentless. So are we. We are driven by a desire to do better for cancer patients, lowering the burden of toleration and safety while at the same time raising the bar on clinical efficacy and duration. As an emerging, global biotech with locations in Boston, Basel, London, and Oslo, we take advantage of diverse scientific depth and insights, which makes ARTBIO a unique place to work. EEO StatementARTBIO is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know. Questions and Application ProcessIf interested, please apply and send your CV to HR@artbio.com. All inquiries are treated confidentially. ARTBIO does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between ARTBIO and the agency. ARTBIO will not pay any fees related to unsolicited resumes.

Job DescriptionScholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the Company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn. Summary of Position: The Sr. Medical Director, Drug Safety & Pharmacovigilance is a key position within the company and safety department, with significant impact on the development and life cycle of drug development projects. Responsible for providing safety strategy, expertise, and guidance, pre- and post-approval for assigned products, the Sr. Medical Director will drive the proactive implementation of risk management initiatives in accordance with global regulatory requirements. Core responsibilities will encompass continuous and efficient evaluation of safety data, perform signal detection, evaluation and assessment and management of the safety profile of the compound. In addition, the position will work closely with cross functional teams and Departments for achieving project goals, within timelines & with high quality.Position Responsibilities: • Lead and support development of pharmacovigilance strategies for products within Therapeutic area, to ensure compliance with corporate clinical development and commercial goals., • Oversight and conducting of signal detection activities include monitoring, evaluation, interpretation, management and communication of safety information., • Responsible for oversight and conduct of Product Safety Committee (PSC) meeting(s) to evaluate risk-benefit for the compounds with support from cross-functional teams. Escalate and present safety issues to the Executive Safety Committee., • Medical safety review including causality assessment of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing and literature) throughout the development process for assigned compounds/projects., • Provides medical expert safety review input into all critical documents for products in clinical development (e.g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinical research reports (CSR)), • Oversight of aggregate reports and signal evaluation reports for assigned projects., • Responsible for the Clinical content of responses to inquiries from regulatory authorities related to Safety topics., • Provide leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery of services. Ensures vendor oversight of outsourced Medical activities, as applicable., • Oversee and collaborate with internal safety scientists within TA, • Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws., • Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., DMCs, Vendor oversight meetings, etc.), • Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement. Ability to be flexible and adapt quickly to the changing needs of the organization., • Support process improvement and functional training at departmental & company level, • Ensure that the highest quality, ethical & professional values are demonstrated in all aspects of work., • Ensures compliance with corporate policies and procedures, as well as all related healthcare laws and regulationsCandidate Requirements:, • MD or MBBS or MD-PhD or equivalent medical degree, • 5 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance., • Strong understanding of pharmacovigilance regulations in the US and EU., • Experience in supporting drug safety activities in registrational clinical studies, • High level of medical competence, with an ability to balance this with industry standards to achieve business goals, • Demonstrated skills in scientific analysis and reasoning., • Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance., • Prior IND, as well as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable, • Strong track record of delivering results through effective team and peer leadership in matrix, • Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies.Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job Description PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes. RESPONSIBILITIES The Senior Medical Writer position requires writing and editing of clinical and scientific reports including summaries from statistical analyses for submission to regulatory agencies or sponsor use, comprehensive literature reviews, abstracts, posters, and other projects requiring skill in written communication. The Senior Medical Writer will also assist with and contribute to departmental leadership initiatives, training initiatives, business development efforts and organizational thought leadership. The Senior Medical Writer will: • Mentor and train junior medical writers and/or external contractors, • Work with the sponsor’s and/or PROMETRIKA’s medical personnel and statisticians to develop/write clinical development plans, clinical study protocols, clinical study reports, and other documents, as appropriate, • Create template/shell for integrated clinical study report based on ICH guidelines and sponsor’s standards and in accordance with the study protocol, • Hold review meetings to discuss edits provided by the PROMETRIKA team and/or the sponsor, as needed, • Write journal articles, abstracts, and posters in cooperation with responsible statisticians and/or the sponsor, • Develop/write clinical sections of INDs, NDAs, and other submission documents, • Write investigator brochures, • Prepare annual reports and briefing documents for regulatory submission, • Manage consistency of style, format, and content for all IND and NDA documents within a given project, • Review and provide feedback on medical writing SOPs, • Attend project team and client meetings as required, • Assist with contributing materials and presenting at internal Lunch and Learns to cross-train and share Medical Writing expertise within our organization, • Assist with contributing to PROMETRIKA’s newsletters, thought leadership blogs, and other publications as appropriate, • Support in collaborating with Client Relations to participate in Medical Writing at bid defense meetings, • Assist with leading Medical Writing departmental initiatives aligned with organizational strategic goals, • Uphold, demonstrate and teach junior team members PROMETRIKA’s Core Competencies, • Assist with developing internal training materials and deliver training as in support of PROMETRIKA Technical Training Committee initiatives, • Perform other duties as assigned EDUCATION • Bachelor’s degree in a scientific discipline is required, • Graduate degree is preferred EXPERIENCE • Minimum of 6 years of experience in medical writing with a minimum 4 years regulatory writing in biotechnology/pharmaceutical industry SKILLS • Knowledge of ICH recommended content of Investigator Brochure, Clinical Study Report, IND, IND updates and NDA along with previous involvement in writing at least one NDA or BLA is required., • Knowledge of electronic document platforms is desired, • Additional knowledge/experience in other aspects of drug development (e.g., clinical trial monitoring, data management, statistics) is preferred Physical Requirements Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time. The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate’s work experience, education/training background and parity with current employees in the same or similar positions.

Job Summary We are seeking a Data Governance Architect to design and implement enterprise data governance capabilities across modern pharma data platforms. The ideal candidate has deep experience in pharmaceutical or life sciences data environments, strong knowledge of Databricks Lakehouse and Medallion Architecture, and hands-on experience with Collibra and Unity catalog for metadata management, business glossary, data cataloging, stewardship workflows, lineage, and governance operating models. This role will define the technical and information architecture required to govern data across R&D, clinical, regulatory, manufacturing, quality, commercial, and enterprise data domains. *Must be onsite 3 days a week in Cambridge, MA Key Responsibilities Design and implement enterprise data governance architecture across pharma data platforms, including Databricks, Collibra, cloud storage, BI, and downstream analytics systems. Define governance patterns for Databricks Lakehouse, including Bronze, Silver, and Gold layers, data ownership, metadata standards, lineage capture, access control, data quality, retention, and certification. Partner with data engineering teams to embed governance controls into Medallion Architecture pipelines, including ingestion standards, transformation rules, validation checkpoints, and curated data product governance. Lead Collibra architecture and configuration for data catalog, business glossary, data domains, assets, policies, stewardship workflows, lineage, and data quality integration. Define metadata models connecting business terms, data products, datasets, reports, pipelines, data owners, data stewards, and regulatory classifications. Architect governance solutions using Databricks Unity Catalog, Collibra, cloud IAM, privacy tools, security controls, and data quality frameworks. Establish architecture standards for sensitive and regulated pharma data, including GxP, HIPAA, GDPR, clinical trial data, patient data, manufacturing quality data, and proprietary R&D data. Create reference architectures, solution blueprints, implementation patterns, data governance standards, and technical design documents. Advise on integration between Collibra and Databricks for metadata harvesting, lineage, catalog synchronization, stewardship workflows, and governance policy enforcement. Support enterprise data product strategy, including data mesh, domain ownership, certified datasets, data marketplaces, and reusable governed data assets. Collaborate with enterprise architecture, data platform, security, privacy, compliance, quality, and business data domain teams. Required Qualifications 8+ years of experience in data architecture, data governance architecture, information architecture, data management, or enterprise data platforms. Experience working in pharma, biotech, life sciences, healthcare, or another regulated industry. Strong understanding of Databricks Lakehouse Platform, Unity Catalog, Delta Lake, access controls, lineage, workspace patterns, and data platform governance. Hands-on experience with Medallion Architecture, including Bronze, Silver, and Gold data layers. Hands-on experience with Collibra, including operating model design, data catalog, glossary, workflows, stewardship, lineage, policies, and asset model configuration. Strong knowledge of data governance capabilities, including metadata management, lineage, data quality, master/reference data, access management, privacy classification, data lifecycle, and policy management. Experience designing governance frameworks for regulated data, including GxP, 21 CFR Part 11, HIPAA, GDPR, patient data, clinical data, and quality data. Ability to translate business, regulatory, compliance, and privacy requirements into scalable technical architecture. Experience with cloud data platforms, preferably AWS, Azure, or GCP. Excellent documentation, communication, and stakeholder engagement skills. Preferred Qualifications Experience integrating Collibra with Databricks, Unity Catalog, cloud platforms, BI tools, ETL tools, or data quality tools. Experience with data quality platforms such as Great Expectations, Deequ, Informatica DQ, Collibra DQ, Soda, or Monte Carlo. Experience with data marketplace, data mesh, domain-driven data ownership, and governed data product models. Experience with pharma data domains such as clinical trials, genomics, regulatory submissions, pharmacovigilance, manufacturing, quality, supply chain, medical affairs, or commercial analytics. Knowledge of semantic layers, ontology, master data management, reference data management, and knowledge graphs. Certifications in Databricks, Collibra, CDMP, cloud architecture, or enterprise architecture are a plus.

Category Manager - Expanded Access Programs (Hybrid) Location: Waltham, MA (Preferred) or Upper Providence, PA Schedule: Hybrid - Onsite 2 days per week Pay Rate: $80-$90/hour Alphanumeric is hiring a Category Manager to work in Waltham, MA with our client of over 20 years, a global biopharmaceutical company committed to improving lives through innovative medicines and scientific advancements. This role will provide operational leadership and oversight for oncology Expanded Access Programs (EAP) and Compassionate Use (CU) programs, ensuring patients have access to investigational therapies while maintaining compliance with regulatory requirements, company policies, and industry standards. Responsibilities • Partner with internal stakeholders to provide operational leadership for oncology Expanded Access and Compassionate Use programs, • Develop and execute program strategies related to geographic footprint, drug supply, regulatory coordination, physician engagement, safety reporting, and overall program management, • Oversee the selection, onboarding, and management of vendors supporting access programs, • Establish operational processes that ensure rapid and effective responses to physician requests regarding patient access to EAP/CU programs, • Monitor program utilization and provide regular status updates, metrics, and insights to key stakeholders, • Collaborate cross-functionally with Global Medical Affairs, Clinical Operations, Supply Chain, Regulatory Affairs, Pharmacovigilance, Local Operating Companies (LOCs), physicians, and external partners, • Support program planning, implementation, and continuous improvement initiatives, • Ensure all program activities are conducted in compliance with applicable regulations, company policies, and Standard Operating Procedures (SOPs), • Identify operational risks and implement mitigation strategies to ensure successful program execution., • Build and maintain strong working relationships across internal and external stakeholder groups Qualifications • Bachelor's degree in Life Sciences, Business, Healthcare Administration, Supply Chain, or a related field, • Experience supporting Expanded Access Programs (EAP), Compassionate Use Programs (CU), Medical Affairs, Clinical Operations, Patient Access, or related pharmaceutical programs, • Strong project management and operational leadership skills, • Experience managing external vendors and service providers, • Knowledge of pharmaceutical regulatory requirements and compliance standards, • Excellent communication, stakeholder management, and relationship-building skills, • Ability to manage multiple priorities in a fast-paced, highly collaborative environment, • Strong analytical, organizational, and problem-solving abilities Preferred Qualifications • Oncology experience within the pharmaceutical or biotechnology industry, • Experience working with global cross-functional teams, • Familiarity with safety reporting, drug supply management, and regulatory coordination processes

We are looking for a pharmacovigilance auditor with experience in Good Manufacturing and Good Distribution practices (GMP and GDP) as well as experience in patient support and market authorization.

• Candidates Must Reside Within the Houston, TX Area* Purpose and Scope Under limited supervision, the Account Manager- PE is responsible for achieving sales objectives in assigned territory through the development, maintenance, and enhancement of the business. These customers include Pediatric Endocrinologists, nurses, pharmacists, pharmacy and therapeutics groups, teaching institutions, private and federal hospitals and formulary committees. The Account Manager- PE is responsible for ensuring customer’s clinical conviction in the product and seeing the sale through to its conclusion by providing sufficient training and ongoing customer service. The Account Manager- PE will develop territory business plans and work with the sales management team to maximize the impact of sales and marketing plans and tactics. Essential Duties & Responsibilities • Create, maintain and increase sales within designated territory by influencing the prescribing habits of the targeted audience by calling on health care providers and health-related organizations within assigned territory., • Strategically identify and develop relationships with non-prescribing health care providers that influence decision making in accounts such C suite personnel, pharmacy personnel, injecting nurses, Medical Assistants, office managers and personnel, etc., • Sell in various sites of care within territory including clinics and health systems (all sites of care within health systems including but not limited to Specialty Pharmacies, In patient pharmacies, infusion centers, specialty clinics etc., • Conduct effective and compliant mixing and administration demonstrations to appropriate customers, • Demonstrate advanced business acumen, • Demonstrate thorough on-label knowledge of products by effectively communicating appropriate clinical, technical, therapeutic, disease state and product information to customers., • Complete routine reports and be compliant with industry, regulatory and company guidelines and prepare annual business plans and conduct quarterly analysis of the territory performance vs. plan., • Attend and represent the Company at internal company meetings and external trade shows, community events, etc, as appropriate., • Manage usage and inventory of promotional items to be given away to offices., • Abide by Administrative Expectations as defined by AMP SOPs: Submit expense reports regularly as outlined, enter sales calls in CRM system daily or as indicated by Regional Sales Director, enter company car mileage weekly, maintain company car as required by Fleet Maintenance., • Manage promotional budget effectively and in a compliant manner., • Partner with different departments in the Company as the business requires., • Abide by the Company’s email and communication SOPs., • Regular and punctual attendance is an essential function of the job. It is expected that our sales force is “in the field” calling on customers from 8:00am to 5:00pm each day., • Responsible for reporting Adverse Events and Technical Complaints to Tolmar Pharmacovigilance and Patient Safety (PSSP) that you learn of per SOP-00821, Pharmacovigilance and Technical Complaint Reporting., • Perform other duties as assigned. Core Values This position is expected to operate within the framework of Tolmar’s Core Values: • Center on People:We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.​, • Are Proactive & Agile:We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.​, • Act Ethically:We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace., • ​Constantly Improve:We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.​, • Are Accountable:We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.​ Knowledge, Skills & Abilities • Highly motivated for success with a “can do” attitude., • Excellent interpersonal, written and verbal communication skills and organizational skills, • Skill in negotiation and selling techniques as aligned with company expectations with demonstrated accountability in executing sales plans., • Aptitude for learning technical and scientific product relation information., • Demonstrate assertive selling techniques including asking for business on every call., • Excellent analytical skills and proven strategic thinker., • Ability to work independently and manage multiple projects both inside and outside the organization., • Ability to execute effective business plans for assigned territory., • Ability to develop working relationships with both internal and external customers and work as a team player with employees at all levels., • Ability to take initiative in the absence of precise direction., • Ability to demonstrate good judgment, discretion and compliance to industry ethical guidelines., • Ability to be approved and insured to drive company fleet vehicle, including valid driver’s license and good driving history., • Knowledge of Microsoft Office products, CRM systems and virtual platforms. Education & Experience • Bachelor’s degree in science, business or related field., • Consistent and proven track record of exceeding sales quotas., • 5 or more years of successful independent pharmaceutical and/or business-to-business sales experience, Pediatric Endocrinology, Rare Disease and/or Buy and Bill sales experience preferred., • Reside within the territory and willingness to cover the entire assigned geographical sales space., • Pharmacy sales experience is preferred, including Specialty Pharmacy, Health System Based Pharmacies etc., • Clinical experience helpful. Working Conditions • Role requires sitting, driving and standing., • Overnight travel is required for up to 75% of work week, dependent upon geographic footprint coverage expectations, • Ability to lift 50 pounds., • Travel by air as required., • Availability to work extra hours and on weekends as necessary. Compensation Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience. The pay range for this position at commencement of employment is expected to be between ($140,000 and $175,000/year); however, while salary ranges are effective from 1/1/26 through 12/31/26, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. About Tolmar Tolmar is proud to have earned a reputation for performance and innovation. Through a progressive company culture, Tolmar has established a legacy as a trusted name in the research, development and manufacturing of high quality topical products used in dermatology, and extended release dosing forms for products commonly used in urology and oncology. Founded in 2006, we are a private company known internationally for our advanced drug delivery capabilities and our unmatched commitment to our partners, and to the patients and provider communities we serve Since our inception, Tolmar has produced 22 marketed products supported by 5 New Drug Applications (NDAs) and 17 Abbreviated New Drug Applications (ANDAs) across urology and oncology and dermatology. With more products forthcoming, our dedicated pipeline reflects Tolmar’s future-focused approach Tolmar offers exciting opportunities that will leverage your abilities, expand your skills, and reward your contributions in an atmosphere that encourages both personal and professional growth. Additionally, Tolmar offers competitive compensation and excellent benefits including: • Competitive and inclusive medical, dental and vision coverage options, • Flexible Spending Accounts for medical expenses and dependent care expenses, • HSA through our HDHP, • CompleteCare reimburses you and your dependents for eligible health care expenses and premium expenses incurred under alternate group health coverage, • Generous 401K match - currently match 100% of your contributions up to the first 6% of compensation and 50% from 7%-12%, but never greater than 9%, • Tolmar-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options, • Employee Assistance Plan, Legal Guidance and Funeral Planning & Concierge Services, • Adoption and family-planning benefits, Fertility and Family Forming Benefits, • Generous paid time off, including:, • Vacation, sick time and holidays, • Volunteer time to participate within your community, • Discretionary year-end shutdown See More @ https://tolmar.com/working-at-tolmar/ We provide a positive work environment designed around the philosophy of mutual respect and the challenge and rewards of contributing to the continued success of our organization. Tolmar is committed to fostering, cultivating and preserving a culture of diversity, equity and inclusion. Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

POSITION SUMMARY: Natera is seeking a highly motivated and experienced Clinical Scientist to support the development and execution of our innovative Oncology programs. The Director, Clinical Science will ensure the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners. The Director, Clinical Science will be accountable to jointly develop clinical program strategy and work collaboratively together with other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelines. Specifically, the candidate will work closely with colleagues cross functionally in clinical development, clinical operations, data management safety/pharmacovigilance, regulatory, biostatistics, translational medicine, and program leadership. PRIMARY RESPONSIBILITIES: • Develop study concepts, including study design, schedule of assessments, objectives/endpoints, and eligibility criteria, • Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required, • Provide protocol training and contribute to CRF design, • Ensure study manuals align with protocol and engage investigators in study design, • Seek input from key investigators on study design and methodology to ensure alignment with research objectives, and actively participate in pre-site selection discussions, site initiation visits, and investigator meetings to support successful study execution, • Contribute to and oversee real-time clinical data reviews (including oversight of CROs when applicable), • Serve as a clinical science representative on internal and external meetings, • Develop clinical project execution timelines and provide status updates to senior management to ensure the timely delivery of program milestones, • in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming, • Support meetings (advisory boards, etc) and deliver presentations, • Drive clinical research plans, including company and investigator-initiated studies, • Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives, • Build relationships with KOLs, consortiums, and sites, • Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for registration of the product, • As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists, • Manage one or more direct reports including being responsible for hiring, training, developing, and retaining talent on staff, as needed, • As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects, • Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment, • Ensure HIPAA/PHI compliance and maintain training requirements, • Perform other duties as assigned QUALIFICATIONS: • Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field) preferred, • 10+ years of pharma/biotech industry experience in clinical development in oncology clinical trials, • Deep understanding and preferably experience in oncology molecular diagnostics, oncology companion diagnostics or early cancer detection, • Experience in data review, data cleaning, managing and interpreting clinical trials results as well in writing clinical trial protocols, • Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research, • Experience with managing direct reports, ensuring that roles are performed in accordance with job descriptions and that training is conducted and maintained appropriately KNOWLEDGE, SKILLS, AND ABILITIES: • Problem-solving skills and a fast learner, • Strong communication (oral and written) and attention to detail, • Ability to work independently and collaboratively, • Analytical and creative thinking, • Familiarity with Google and Microsoft suites, • Desire to work in a dynamic environment, • "Hands-on" leadership and a strong work ethic, • Ability to apply business knowledge, exercise judgment, and escalate issues appropriately, • Strong project management, organizational, and interpersonal skills, • Adaptability, initiative, and team-building skills, • Demonstrated success in working in a cross-functional environment, • Successful and superior influencing skills across all levels of the organization and external collaborators, • Conflict resolution and follow-through skills, • Results and goal-oriented, • Strategic and flexible thinking PHYSICAL DEMANDS & WORK ENVIRONMENT: • Office or home office setting with internet access, • Ability to use a computer, phone, and read materials, • Flexibility to work with colleagues in a global setting, • Able to engage in work-related travel up to 25% The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations. Remote USA $192,600 - $240,800 USD OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit _. Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: _ Please be advised that Natera will reach out to candidates with a @_ email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information: • _, • _

This job is with Biogen, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. About This Role The purpose of the Global Labeling group is to drive Biogen's regulatory labeling strategy and ensure that labeling documents are of high quality and compliant for the safe and effective use of our products globally. As a Global Labeling Associate Director, you would be responsible for developing the labeling strategy, leading the development and update of core, EU and US labeling documents and for overseeing implementation at a regional and local level. In this role, you may be responsible for overseeing the strategy for other products within your Therapeutic Area. What You'll Do Lead timely creation or management of regulatory compliant, competitive and up to date core, EU and US labeling documents throughout the product lifecycle including the Target Label Profile, Core Data Sheet, EU SmPC and USPI Lead the cross functional product Labeling Team to reach consensus on labeling matters, accurately capture and communicate decisions, and obtain endorsement by senior management Critically assess the data and propose the labeling strategy to be followed in core, EU and US labeling documents, ensuring alignment with global, regional and local regulatory strategies Oversee distribution and tracking of Core Data Sheet updates for assigned products, ensuring compliance is maintained within the Electronic Document Management System and the Regulatory Tracking System Understand scientific concepts to critically assess clinical data, enable proactive interactions with appropriate stakeholders, influence the clinical development plan Develop and implement strategy for global, EU and US labeling content Identify underlying processes and principles for developing product claims representing the risks and opportunities to the project team Partner with key stakeholders to ensure product labeling is the most current, accurate, relevant and competitive to inform prescribers and patients Who You Are You will have a passion for strategic regulatory labeling and will be enthusiastic to aid in the evolution of a new labeling department in a growing company. You will have a strong scientific grounding, an excellent eye for detail and a demonstrated understanding of the importance of labeling governance and compliance. Required Skills Bachelor's degree in a scientific or medically related discipline 6+ years pharmaceutical/ biotechnology industry regulatory experience, including global, EU and US regulatory labeling Advanced knowledge and understanding of applicable regulations, pharmacology, medicine, pharmacovigilance and drug development Experience in interpretation of global, EU and US regulations, guidelines, policy statements, etc. Proven ability to successfully understand regulatory implications of product strategy with regard to the product label, assessment and practical management of associated impacts Demonstrate effective cross-functional and cross-cultural skills to effectively interact with global counterparts Well organized, detail oriented, highly effective written and oral communication skills Job Level: Management Additional Information The base compensation range for this role is: $160,000.00-$220,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to: • Medical, Dental, Vision, & Life insurances, • Fitness & Wellness programs including a fitness reimbursement, • Short- and Long-Term Disability insurance, • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31), • Up to 12 company paid holidays + 3 paid days off for Personal Significance, • 80 hours of sick time per calendar year, • Paid Maternity and Parental Leave benefit, • 401(k) program participation with company matched contributions, • Employee stock purchase plan, • Tuition reimbursement of up to $10,000 per calendar year, • Employee Resource Groups participation Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. _ to learn more about Biogen. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

Creative Solutions Services, LLC is looking for a Veeva Safety Specialist to implement and maintain Veeva Vault Safety solutions in the pharmaceutical industry. This role requires strong experience in managing safety processes, system issues, and ensuring compliance with GxP regulations. The ideal candidate will have over 10 years of experience in Veeva Vault Safety administration and a solid understanding of pharmacovigilance operations. Excellent analytical and communication skills are essential for this position. #J-18808-Ljbffr

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Medical Director, Clinical Science, Solid Tumor in our Cambridge office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. OBJECTIVES: The Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compounds. Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the ultimate responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned compound in multiple regions. Applies clinical/medical decision making to clinical development issues. This individual interacts with and influences TGRD and TPC senior leadership decision-making for the projects by setting strategic direction. Success or failure directly translates to the ability of TGRD to meet its corporate goals and for Takeda to have future commercial products. ACCOUNTABILITIES: • Clinical Development team participation and leadership, • Leads Global (US/EU/Japan) Development Team managing both the US/EU Development Team and the Japan Development Team for a given product. May lead the US/EU Development Teams and represents Clinical Science on the Global (US/EU/Japan) Development Team to ensure that activities are aligned with the global strategy., • Establishes and drives Development Team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, and influence the budget of all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them., • Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development such as "go/no go" decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. A significant error in judgment may result in loss of approvability and commercial viability of a product., • Synopsis / Protocol Development, Study Execution, & Study Interpretation, • Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to other clinical scientists involved in these activities, and is accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determine how individual study results impact the overall compound strategy., • Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients., • Trial Medical Monitoring, • Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues., • Makes final decisions regarding study conduct related to scientific integrity., • External Interactions, • Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas. These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders. Lead roles will also be taken on the incorporation of advice / recommendations received into the design of clinical studies / programs as appropriate; accountable to senior leadership for the successful completion of related objectives., • Due Diligence, Business Development and Alliance Projects, • Responsible for identification and evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities. Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC., • Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda's strategic goals while striving to maintain good working relationship between Takeda and partner., • Leadership, Task Force Participation, Upper Management Accountability, • Interacts directly with research division based on pertinent clinical and development expertise and with TPNA/TPEU to provide knowledge / understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds. May represent clinical science on multidisciplinary task forces across divisions (e.g. TGRD and TPNA/TPEU/TPC). Lead TGRD internal teams and may lead global cross-functional teams, as appropriate., • Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: Education/ Experience • MD, combined MD/PhD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned)., • Training and Experience in Hematology/ Oncology and/or Medical Oncology especially in solid tumor malignancies is preferred, • Experience in conducting and/or leading clinical trials involving immune-based therapies and/or antibody-drug conjugates is preferred., • Late phase clinical development and NDA/MAA/Submission experience is preferred., • Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions., • Management experience Skills • Excellent communication and influencing skills, with the ability to engage, inspire, and influence stakeholders at all levels, including executive management and external partners. Ability to proactively predict issues and solve problems, • Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams, • Diplomacy and positive influencing abilities Knowledge • Therapeutic area knowledge relevant to mechanism of action, • Regional/global Regulatory requirements, • GCP/ICH, • Emerging research in designated therapeutic area TRAVEL REQUIREMENTS: • Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required., • Requires approximately 15 - 25% travel. Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Associate Director, Statistics in our Cambridge, MA office.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Here, you will be a vital contributor to our inspiring, bold mission.POSITION OBJECTIVES:Takeda's mission is to serve patients. This patient focus drives the organization to create the medicines patients need and the innovations that will deliver genuine improvements to their lives. Takeda insists on a high standard for innovation in order to deliver true value to patients, healthcare providers, payers and other stakeholders.The R&D Data and Quantitative Sciences organization influences senior leadership and stakeholders to advance Takeda's R&D pipeline. Central to Takeda's R&D operating model are the pillars of Data & Quantitative Sciences, which are leveraged to support the imperative of becoming a data-driven and scientifically and quantitatively disciplined rigorous organization. This focus enhances the speed and success of R&D growth and strengthens competitiveness. R&D Data & Quantitative Sciences encompasses several global functions, including Quantitative Pharmacology and Translational Sciences, Statistics & Quantitative Sciences, Programming, Patient Safety & Pharmacovigilance, and Strategic OperationsThe Statistics and Quantitative Sciences (SQS) department integrates data science, analytics, and quantitative methods to enhance efficiency and precision throughout the drug discovery and development lifecycle. It leverages cutting-edge technology, machine learning, AI, and statistical methods to analyze complex datasets, generate predictive models, and provide actionable insights. It collaborates cross-functionally to ensure scientific rigor and compliance with regulatory standards in all decision-making processes.POSITION ACCOUNTABILITIES:Lead delivery for one or more assets at GPT level or specialty area in preclinical, clinical, translationalFacilitate execution and delivery collaboration cross functionally in Global Project Teams (GPTs), generally within DQS and R&D, and with external vendorsEnable the consistent execution of the SQS and DQS seamless and predictable delivery missionLead and be accountable for asset level delivery strategies being implemented with effective risk identification and mitigationCreate an internal cross functional and external with vendors sphere of influence in predictable deliveryIdentify opportunity for continuous improvement in delivery approaches and leverages fit-for-purpose mitigations by leveraging themEDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Education:Must have degree in statistics/biostatistics or in other equivalent quantitative sciences along with the following specific credentials:PHD with ~ 5 years experienceMS with ~ 8+ years experienceTechnical Skills:Subject matter expertise in several quantitative and statistical areas and establishes oneself as a go-to colleague on a few topicsScientific understanding of drug R&D to inform methodological input with product team or in a platformStrong communication skills and ability to translate effectively across functional linesAbility to Identify and research new innovative approaches and leverage fit-for-purpose methods in to programsEnable the tactical execution of the SQS and DQS vision and missionLead and be accountable for asset level strategies being implementedDemonstrate mentorship, matrix or direct management of small team of SQS colleaguesFacilitate collaboration cross functionally in GPTs and generally within DQS and R&DCreate an internal and external sphere of influence in area of expertiseThis position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.Empowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.LI-JV2Takeda Compensation and Benefits SummaryWe understand compensation is an important factoras you consider the next step in your career. We are committed to equitablepay for all employees, and we strive to be more transparent with our pay practices.For Location:Boston, MAU.S. Base Salary Range:$154,400.00 - $242,550.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Moderna is seeking a motivated and energetic Associate Director level project manager responsible for providing project management leadership to enable execution of cross-functional process building and improvement projects across the Development organization. This position will play a role in helping to establish a centralized function that will drive critical strategic projects, support building a continuous improvement capability that will enable the Development organization to scale as we look to establish key internal capabilities in support of operational excellence in our clinical trials and deliver on the promise of mRNA technology. This role will be responsible to develop strong oversight and execution for projects and initiatives which may include developing a business case and project plan to support internal approval, as well as managing the capability build through implementation. These projects will include key partnerships across our clinical Development functions: Clinical Development, Business Operations and Process Improvement, Clinical Operations, Clinical Supply and Biomarkers, Data Management / Biostats and Programming, Medical Writing, Clinical Study Execution Enablement (start-up, patient recruitment / retention, site engagement), and can include Digital, Commercial, Finance, Safety & Pharmacovigilance, Regulatory, Supply Chain, Quality and more with the critical responsibility of integration across all those processes related to the projects. The Associate Director will develop timelines, provide oversight, escalation, support the business lead functions within project teams in project planning, implementation planning and drive execution and manage and mitigate risk, and coordinate interdependencies. Here's What You'll Do: • Core project-based responsibilities, • Direct multiple complex projects involving internal and external stakeholders and vendors, • Partner with the relevant functional leadership to drive project strategy and execution plan, • Provide and support leadership to projects; be the hub of knowledge and source of truth, • Own the roadmap for one or more high-impact initiatives, from ideation through steady-state operations; create cross functional project plans to ensure clarity of deliverables and timing, • Manage project team meetings to include agenda planning, drive agenda, decision tracking and action follow-up., • Stakeholder management, • Build relationships with key stakeholders (team members and leadership) to ensure alignment of functional and corporate objectives, • Influence without direct authority across Clinical, TechOps, Digital, Quality, Finance, and external partnerssurfacing trade-offs early and driving alignment, • Cross-project integration, process excellence and continuous improvement, • Champion data-driven decision-making, partnering with our digital and analytics teams to embed metrics and automation into process, workflows, • Stand up or optimize process frameworks (e.g., RACI, stage-gates) that enable continuous improvement, • Track, report and facilitate the resolution of issues and risks across several integrated projects, • Support central strategic operations to provide leadership visibility to timing, roadmap, reporting and improving central processes around initiative development Here's What You'll Need: • BS degree in a scientific field with at least 8 years of experience or MS degree in a scientific field with 4 years of experience in a biotechnology or pharmaceutical setting, • PMP certification preferred, • Experience in clinical drug development, • Understanding and experience in GCP and/or GXP environment is preferred, • Proven track record of successful project management experience and knowledge of project management tools/software, • Demonstrated experience in leading cross-functional programs in business setting, consulting setting and preferred in established development organization, • Must be adept at working in a fluid environment and foster a strong collaborative spirit internally and externally., • Strong personal skills to influence without authority, motivate others and manage conflict., • Strong written and oral communication skills as well as demonstrated organizational aptitude, • Demonstrated wins in supporting process design or re-engineering (Lean, Six Sigma, or similar), • End-to-end digital-implementation experience from the business side (requirements gathering, UAT, change management, and adoption metrics), • Executive-caliber communication skills written and verbal; able to distill multifaceted problems into slide narratives and simple frameworks, • Working knowledge of portfolio tools (e.g., Smartsheet, Excel) Here's What You'll Bring to the Table: • Experience internalizing activities traditionally outsourced to CROs or other vendors, • Familiarity with GxP digital validation and data-integrity principles, • Exposure to mRNA, oncology, or platform-based drug-development environments At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support youat work, at home, and everywhere in between. • Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs, • A holistic approach to well-being, with access to fitness, mindfulness, and mental health support, • Lifestyle Spending Accounts to personalize your well-being journey, • Family planning and adoption benefits, • Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown, • Savings and investment opportunities, • Location-specific perks and extras About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

Permanent, full-time role with competitive remuneration and benefits Location: NSW (Sydney or Regional NSW located close to an airport) A chance to lead, influence and grow in a fast moving, high impact industry Build your career in a role with real commercial scope and visible impact Join a team where your expertise, energy and leadership will make a difference Our company operates within the Australian Animal Health industry, which is highly regulated and highly competitive. Success depends on building customer and end user loyalty, optimising returns in the categories where our company has an offering, and ensuring products are embraced by end users because of their technical differentiation, high quality, and professional support. This Regional Sales Manager role sits within the Animal Health and Animal Identification OTC operation of our company's Ruminant Business Unit (RUBU) and reports to the National Sales Manager of our company's RUBU BioPharma + Identification Over the Counter (OTC) operation. The role is a key member of the OTC Leadership Team. The role is accountable for developing and implementing National Sales and Marketing strategies to achieve regional net sales revenue targets and drive ongoing growth. It is also responsible for managing several regional key accounts, as well as leading, coaching, mentoring and driving a dedicated sales team through a culture of high performance and accountability. What You Will Do Responsibilities include, however not limited to: Sales Team Management • Manage the sales focus of the Regional Sales Team to maximise annual gross sales in the region, • Coach, mentor, develop and drive each individual member of the Regional Sales Team, • Ensure the sales team executes targeted sales, marketing and technical strategies to support the company's brands and maximise sales of the Business Unit's (BU) product range in the region, • Liaise closely with peer sales leaders and the BU's Marketing and Technical Team to ensure co-ordinated and efficient execution, • Contribute to the development of the BU's annual Sales and Marketing strategy and longer-term strategic plan, • Translate the overall strategy into regional sales initiatives, • Identify and develop new growth business opportunities, • Ensure effective utilisation of promotional budgets and resources, • Drive growth of key brands, • Leverage technology to achieve an optimal customer and end user experience, • Communicate effectively across the company's business units to achieve common business outcomes, • Ensure a high level of PV (pharmacovigilance) and compliance is embedded in the culture of the Regional Sales Team Customer Key Account Management • Ensure the sales team develops and maintains effective relationships with OTC customers, veterinary health care professionals (HCPs), key opinion leaders (KOLs), regional Agriculture Department staff and end users, • Key account management of the regional offices of the major national customers, head offices of several mid-sized Regional Key Accounts based in New South Wales, and selected large end users, • Identify, establish and maintain strategic personal relationships with key industry figures beyond the customer base Reporting / Customer Relationship Management (CRM) Embracement • Prepare monthly net sales forecasting for the region at Day 0 and Day 15 of each month, • Provide quarterly net sales projections, with regular updates and variance reporting as required, • Deliver quarterly regional reporting, including customer and competitor activity and planned internal activity, • Ensure CRM account data is accurate to support targeted digital marketing initiatives, • Ensure all sales team members input accurate call reporting data into the organisation's CRM system, • Monitor and report major customer, competitor and consumer activity and trends to the BU Leadership Team as required Talent Development • Provide training and assistance to sales team members in line with company parameters, • Ensure all direct reports have a robust Employee Development Plan in place, • Completion of training identified through the Employee Development Plan or as otherwise required, • Identify own training needs and action these through the development planning process, • Continuous improvement of the sales team's commercial skillset, product knowledge, technical knowledge and Australian farming enterprises, • Unambiguous leadership, priority setting, people management, and regular in-field mentoring Team Leadership and Travel • Lead a geographically dispersed regional sales team based across NSW, • Prioritise in-field coaching and development of sales team members through routine time in territory, • Travel extensively across regional NSW involving regular overnight stays away from home as required What You Must Have • Tertiary qualification preferred, ideally in Life Science or Commercial disciplines, • Prior extensive relevant commercial experience in a sales role, ideally within life sciences or agricultural inputs, • Demonstrated success and strong skillset in sales team leadership, • Proven ability to build strong relationships with senior key customer personnel as well as with other key external stakeholders, • Successful commercial track record in regulated environments, • Ability to model the company's Enterprise Leadership Skills (ELS), Ways of Working, and Values, • An understanding of the Australian Livestock industry, ideally including some technical knowledge of animal health and husbandry, • Ability to solve complex problems and identify innovative solutions, • Excellent IT skills and capability, • Experience in budget management and strong financial acumen What You Can Expect • Lead a high performing sales team and drive regional growth, • Take on a key commercial leadership role within a global Animal Health business, • Build trusted relationships with customers, veterinarians, KOLs (key opinion leaders) and key industry stakeholders, • Make a real impact through your leadership, judgement and influence, • Work in a collaborative, high accountability and values driven environment We are proud to be a company that embraces the value of bringing talented and committed people together. The fastest way to breakthrough innovation is when ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive workplace. Required Skills: Adaptability, Animal Health Care, Commercial Acumen, Commercial Operations Management, Lead Generation, Market Analysis, Meeting Goals, New Product Initiatives, OTC Sales, People Leadership, Regional Sales Management, Results Delivery, Results-Oriented, Ruminant, Sales Forecasting, Sales Leadership, Sales Objectives, Sales Pipeline Management, Sales Reporting, Sales Strategy Development, Strategic Thinking, Technical Product Sales Preferred Skills:

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? We are looking for a Medical Director, Clinical Science, GI2 TAU with experience in nephrology to join us in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: The Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compounds. Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the ultimate responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned compound in multiple regions. Applies clinical/medical decision making to clinical development issues. This individual interacts with and influences TGRD and TPC senior leadership decision-making for the projects by setting strategic direction. Success or failure directly translates to the ability of TGRD to meet its corporate goals and for Takeda to have future commercial products. POSITION ACCOUNTABILITIES: Clinical Development team participation and leadership Leads Global (US/EU/Japan) Development Team managing both the US/EU Development Team and the Japan Development Team for a given product. May lead the US/EU Development Teams and represents Clinical Science on the Global (US/EU/Japan) Development Team to ensure that activities are aligned with the global strategy. Establishes and drives Development Team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, and influence the budget of all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them. Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. A significant error in judgment may result in loss of approvability and commercial viability of a product. Synopsis / Protocol Development, Study Execution, & Study Interpretation Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to other clinical scientists involved in these activities, and is accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determine how individual study results impact the overall compound strategy. Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients. Trial Medical Monitoring Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues. Makes final decisions regarding study conduct related to scientific integrity. External Interactions Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas. These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders. Lead roles will also be taken on the incorporation of advice / recommendations received into the design of clinical studies / programs as appropriate; accountable to senior leadership for the successful completion of related objectives. Due Diligence, Business Development and Alliance Projects Responsible for identification and evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities. Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC. Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner. Leadership, Task Force Participation, Upper Management Accountability Interacts directly with research division based on pertinent clinical and development expertise and with TPNA/TPEU to provide knowledge / understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds. May represent clinical science on multidisciplinary task forces across divisions (e.g. TGRD and TPNA/TPEU/TPC).Lead TGRD internal teams and may lead global cross-functional teams, as appropriate. Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: MD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of the above). Nephrologist preferred Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions. NDA/MAA/Submission experience preferred. Management experience Skills Superior communication, strategic, interpersonal and negotiating skills Ability to proactively predict issues and solve problems Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams Diplomacy and positive influencing abilities Knowledge Therapeutic area knowledge relevant to mechanism of action Regional/global Regulatory requirements Emerging research in designated therapeutic area This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Empowering Our People to Shine Learn more at takedajobs.com . No Phone Calls or Recruiters Please. #LI-JV2 Takeda Compensation and Benefit

Senior Director, Global Medical Safety physician (psychedelics), leads and supports safety team(s) in all aspects of pharmacovigilance and risk management activities for assigned products, both marketed and in development. Ability to act as in-house authority/leader in Global Pharmacovigilance; and

Sign in to set job alerts for “Account Development Manager” roles.Account Development Manager Jobs in United States.Territory Account Executive - New York City.Account Executive (sales to banks + fintechs).Founding Enterprise Account Executive, AI (100% Remote - San Francisco or NYC).Lead Accoun

Reporting to the Senior Medical Director, Pharmacovigilance, the Associate Medical Director, Drug Safety and Pharmacovigilance will lead medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information, provide input on safety reports (DSURs, PSURs, clinical safety asse

Waltham, Massachusetts seeks a Medical Director, Pharmacovigilance to lead product safety strategy overseeing risk management and ensuring regulatory compliance.

Remote Pharmacovigilance Consultant needs four (4) years of experience in Pharmacovigilance. About the job Remote Pharmacovigilance Consultant. Remote Pharmacovigilance Consultant requires:.

This is an individual contributor role reporting to the Head of Pharmacovigilance. MD with a minimum of 8 years Drug Safety/Pharmacovigilance experience in Biotech, Pharma or Clinical Research Organization. The Medical Director, Pharmacovigilance role is responsible for providing medical oversight o

Medical Director, Pharmacovigilance (PV) leads product safety strategy, overseeing risk management, signal detection, and regulatory compliance from clinical development through post‑market, serving as the medical safety expert, managing PV operations, guiding safety document authoring, and collab

Job Title: Pharmacovigilance Specialist / Assistant. FDA & Health Canada pharmacovigilance regulations. Pharmacovigilance / Drug Safety experience.

Experience with EMA and FDA pharmacovigilance regulatory frameworks. Manager, Pharmacovigilance Scientist. Provide pharmacovigilance input into core safety documents including Reference Safety Information (RSI) updates.

Solution Consultant in Boston, MA, to bridge complex pharmacovigilance challenges with innovative cloud solutions.

Planet Pharma Group is seeking a Senior Manager, Pharmacovigilance Compliance in Cambridge, MA.

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. This role requires writing and editing of protocols and scientific and clinical reports including summaries from