A neuroscience-focused biopharmaceutical company
Senior Medical Director, Drug Safety and Pharmacovigilance, Medical Safety
Location
Massachusetts
Posted
22 days ago
Salary
$285K - $369K / year
Seniority
Mid Level
No structured requirement data.
Job Description
Senior Medical Director, Drug Safety and Pharmacovigilance, Medical Safety
Xenon Pharmaceuticals Inc.
Title: Medical Director/Senior Medical Director, Drug Safety and Pharmacovigilance, Medical Safety Location Boston Employment Type Full time Location Type Hybrid Department Clinical Development Pharma covigilance Compensation Base Salary $285K – $369K • Offers Equity • Offers Bonus Job Description: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team. What We Do: We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy, depression and pain. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. In March 2026, we announced positive topline data from our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures (FOS), and we anticipate submitting a New Drug Application to the Food and Drug Administration in the third quarter of 2026. Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication. We also have multiple Phase 3 azetukalner clinical trials underway in major depressive disorder (MDD) and bipolar depression (BPD), based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of our strong heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries to enable potent, selective ion channel targeting. We continue to advance an early-stage pipeline of novel therapeutic candidates, including Phase 1 studies for XEN1701 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are important pain targets. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations. About the Role: We are seeking a Medical Director/Senior Medical Director, Drug Safety and Pharmacovigilance, Medical Safety to join our team. The Medical Director/Senior Medical Director, Drug Safety and Pharmacovigilance, Medical Safety will be accountable for setting the medical safety strategy for the assigned Company’s product in early or late state development and/or post approval. They will be responsible for defining the product’s safety risks, safety risk mitigation strategies and safety risks language for inclusion in clinical development and regulatory documents. They will be also accountable for the benefit-risk assessment of the assigned Company’s product throughout the product lifecycle (from First-In-Human to post-marketing), safety surveillance during clinical development and post-approval, and ensuring corporate compliance with all applicable US and foreign legal and regulatory requirements for pharmacovigilance, signal management and risk management of the assigned Company’s product. The successful candidate will lead a cross-functional Safety Risk Management Team (SRMT), and collaborate closely with colleagues in Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics and Programming, Data Management, Regulatory Affairs, Medical Affairs, non-clinical safety lead, QA and Legal departments amongst others. This position reports to the Vice President, Drug Safety and Pharmacovigilance, Medical Safety, and will be based out of Boston, MA, USA in our Needham office. We will consider remote locations for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. Hybrid positions require a minimum of two onsite days per week. On-site positions require up to five on-site days per week. RESPONSIBILITIES: - Lead the global Medical Safety strategy for assigned company’s product including development and maintenance of the overall safety product profile of the product including safety risk register, risk mitigation, safety risk communication and safety review and surveillance strategies throughout the product lifecycle from First-In-Human to post-marketing. - Ensure timely delivery of safety contributions, in accordance with DSPV processes, to support clinical development strategies and plans throughout the product lifecycle from First-In-Human to post-marketing. - Lead cross functional safety surveillance activities as a product GSL and chair of the SRMT. Key contributor to the review of safety data from all sources and escalate potential safety signals to safety governance when warranted as per governance SOP and work instructions (WI). - Develop a strong working relationship and alignment with the three other pillars of pharmacovigilance: Risk Management and Safety Governance, Safety Surveillance and Aggregate Reports, and Pharmacovigilance Operations, Compliance and Systems. - Develop a strong working relationship with cross-functional colleagues, and in particular close working relationship with Clinical Development physicians and Regulatory Affairs leads, and as needed with Biostatistics and Programming, Data Management, Medical Affairs, Non-Clinical Safety lead, Quality Assurance and Legal departments amongst others. - Foster a culture that promotes a shared company-wide responsibility for “Patient Safety First” by: - Applying an initiative-taking approach to manage medical safety risks through communication with pears and when needed escalation to senior leadership. - Ensuring adherence to regulatory safety compliance and company’s development strategy. - Responsible for contributing medical safety expertise to safety surveillance, signal detection, risk management, benefit-risk assessment and periodic safety update reports throughout the product lifecycle from First-In-Human to post-marketing. - Ensure that safety data from non-clinical studies are reviewed and considered when creating and updating safety risk register and risk mitigation strategies in study protocols (e.g. dose escalation). - Support NDA submission and or ad hoc documents and communications to Regulatory Agencies for assigned Company’s product throughout the product lifecycle from First-In-Human to post-marketing. - The role supports the Head of Medical Safety in ensuring that all safety related activities comply with applicable local and global regulatory standards and pharmacovigilance exchange agreements with corporate partners - Activities include timely submission of all safety reports to worldwide health authorities and in compliance with applicable with worldwide regulatory safety reporting requirements and industry-standard best practice. - Ensure careful and timely review of safety concerns escalated by internal and external stakeholders, including competent regulatory authorities, and develop strategies for safety assessment for assigned Company’s product. - Provide guidance and ensure that safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), and IB Reference Safety Information (RSI) are aligned with the most current Company’s product specific Safety Risk Language. - Provide guidance for safety sections of clinical study documents including Statistical Analysis Plans (SAP), Medical Monitoring Plans (MMP), Clinical Study Reports (CSR), Summary of Clinical Safety (SCS), Integrated Clinical Safety (ICS), Publications, Manuscripts, and other relevant documents. - Responsible for medical review of ICSRs in Company’s Global Safety Database including but not limited to case narrative, MedDRA coding, labeling, causality, company comment and queries for the assigned Company’s product. - Responsible for the medical safety input for the development of Aggregate Safety Reports (ASR) such as Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Reports (PADER), IND Annual Safety Reports, and responses to health authorities’ requests for safety information. - Identify key medical safety issues, trends, and early risk identification for assigned Company’s product and proactively develop and recommend effective mitigation strategies. - Collaborate with Clinical Development and Medical Affairs to develop publications and clinical data communications; review scientific publications such as posters, abstracts, and manuscripts. - Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any - Some international travel may be required - Other duties as assigned QUALIFICATIONS: - Medical degree (MD) required, with at least 5 years’ experience in clinical/medical practice preferred. - Minimum of 7 years’ experience as a safety physician in drug safety & pharmacovigilance for products in clinical trial and post-marketing environments. Neuropsychiatry experience is desirable - Experience authoring and overseeing safety signal assessment report, DSUR, PBRER, RMP/REMS, and RSI. - Experience in all phases of global drug development process from pre-IND through NDA and post-licensure, clinical development and NDA submissions. - Broad knowledge of FDA and EMA regulations, GCP/GVP/ICH guidelines, and other local/global safety regulations. - Experience with Argus or ARISg systems, Global Safety Database data mining and MedDRA coding. - Excellent interpersonal communication and presentation skills - Time management skills with ability to prioritize meeting required deadlines. - Ability to multitask and work under tight deadlines while prioritizing attention to important details and high-quality work in a dynamic environment. - Strong ability to work collaboratively in dynamic small teams of internal and external partners that are a part of a fast-paced environment. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions. Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
Related Guides
Related Categories
Related Job Pages
More Medical Director Jobs
Title: Senior Director, Regulatory Affairs Location: Boston Department: Development Job Description: Bicara Therapeutics is seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy for our biologics pipeline. Reporting to the VP, Regulatory Affairs, you will serve as the primary US regulatory lead with a core focus on BLA strategy and execution—from IND through BLA submission and approval. You will manage a small team of Regulatory Affairs professionals, providing mentorship and oversight while working in close partnership with the VP to ensure alignment on regulatory direction, agency interactions, and submission timelines. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week. Responsibilities - Develop and execute integrated global regulatory strategies to advance investigational oncology assets from early development through approval and lifecycle management, partnering closely with the VP, Regulatory Affairs. - Serve as the global regulatory lead on assigned programs, providing strategic guidance to cross-functional teams (Clinical, Nonclinical, CMC, Biostatistics, Clinical Operations, Medical Affairs, and Commercial). - Lead the planning, preparation, and submission of high-quality regulatory documents to FDA, including INDs, briefing documents, orphan/breakthrough designations, amendments, annual reports, and NDA/BLAs. Collaborate with external vendors for submissions in other regions. - Plan, prepare, and lead health authority interactions, including pre-IND, Type B/C, EOP, and pre-submission meetings; coach and prepare cross-functional teams for successful engagements. - Lead and manage a small US team of regulatory professionals; set priorities, allocate work, and cultivate a collaborative, accountable team culture. - Anticipate regulatory risks across regions and proactively design mitigation strategies; advise on regulatory implications of program decisions. - Monitor and interpret evolving global regulations, ICH guidelines, and oncology-specific policies (e.g., Project Optimus, accelerated approval reform), and translate them into actionable strategy. - Partner with external collaborators, CROs, regulatory consultants, and co-development partners to ensure aligned, efficient execution of global regulatory plans. - Ensure compliance with applicable global regulations and internal quality and SOP requirements; maintain audit-ready regulatory documentation and inspection readiness. Qualifications - Bachelor's degree in a life sciences discipline required; advanced degree (MS, PharmD, PhD, or MD) preferred. - 10-12 years of progressive regulatory affairs experience in the biotech or pharmaceutical industry. - Prior oncology/hematology regulatory experience required, with a track record of contributing to oncology development programs across multiple phases. - Demonstrated experience leading global regulatory strategy, including direct engagement with FDA and EMA; experience with additional ICH regions (e.g., PMDA, Health Canada) strongly preferred. - Proven success leading and preparing teams for health authority meetings and delivering major regulatory submissions (IND/CTA and, ideally, NDA/BLA/MAA). - Demonstrated ability to manage within a cross-functional matrix; prior people management experience highly preferred. - Deep working knowledge of global regulatory requirements, ICH guidelines, and oncology-specific frameworks and expedited pathways (e.g., Breakthrough Therapy, Fast Track, Accelerated Approval, PRIME, orphan drug). - Strong leadership, influencing, and project management skills; comfortable operating within a nimble and fast-paced environment typical of a small, clinical-stage biotech. - Exceptional written and verbal communication skills, including experience presenting to and negotiating with health authorities and senior internal stakeholders. - Detail-oriented, highly organized, and able to manage multiple priorities and competing deadlines. Company Overview Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply. Bicara Therapeutics 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.
Role Description Do you crave an intellectually stimulating role that lets you apply your clinical expertise while continuing to grow and make an impact? As a Medical Director at EviCore, part of Evernorth Health Services, a division of The Cigna Group, you’ll leverage your background in Pain Medicine disciplines to deliver evidence-based medical reviews that support high-quality patient care. Collaborate with healthcare providers and stay current on healthcare regulations and industry developments as you review a wide range of cases. This role offers you the opportunity to build new skills while enhancing the health and vitality of others. We're seeking a detail-oriented individual with good communication, technology, and typing skills, as well as strong clinical judgment. Drive growth in your career with our innovative team. - You’ll start training remotely in a structured environment with support from trainers, mentors, and leadership to set you up for success. - Complete time-sensitive, specialized evidence-based medical case reviews for medical necessity on EviCore’s case management software. - Conduct physician consultation (peer-to-peer) calls with referring providers to discuss evidence–based medical necessity and appropriateness of the requested service or treatment. - Leverage your clinical expertise to recommend alternative services or treatments as necessary. - Work collaboratively with over 500 EviCore physician colleagues to help ensure patients receive proper care via evidence-based decision making. Qualifications - M.D. or D.O. with a current, active U.S. medical license and board certification (ABMS or AOA) in Physical Medicine and Rehabilitation. - Clinical interventional pain experience required. - Eligible to acquire additional state licensure as required. - 3 or more years of relevant clinical experience post residency/fellowship. - Knowledge of applicable state and federal laws, Utilization Review Accreditation Commission and National Committee for Quality Assurance standards is a plus. Requirements - Ability to commit to a set, weekly work schedule (Monday through Friday). - Strong computer skills: ability to work autonomously with automated processes, computer applications, and systems. - Meet physical demands of the role including, but not limited to, typing, speaking, and listening 100% of the time. - In accordance with our HITECH Security Accreditation, company provided encrypted-workstation is required to be hard-wire connected to a modem or router. Wireless connection is not permitted. - If you will be working at home occasionally or permanently, the internet connection must be obtained through a cable broadband or fiber optic internet service provider with speeds of at least 10Mbps download/5Mbps upload. Benefits - Benefits start on day one. - Predictable work schedules. - 100% work from home. - 8 Paid Holidays + 23 PTO Days. - 401(K) with company match. - Reimbursement for continuing medical education. - Career growth opportunities across the enterprise. - Networking with peers across multiple medical specialties. Company Description Evernorth Health Services, a division of The Cigna Group, creates pharmacy, care and benefit solutions to improve health and increase vitality. We relentlessly innovate to make the prediction, prevention and treatment of illness and disease more accessible to millions of people. Join us in driving growth and improving lives.
National Director, US Field Medical Immunology - Admilparant
Bristol Myers SquibbBristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. With a single vision as inspiring as “Transforming patients’ lives through science™”, every BMS employee plays an integral role in work that goes far beyond ordinary.
Role Description The Field Medical organization embodies our medical mission to be recognized as the trusted partner for internal stakeholders and the healthcare community, driving scientific exchange to enhance medical education, data generation, insight generation, and patients’ access to medicine. The Director, Field Medical (FM) Immunology (IMM) - Admilparant role is field-based and focused on leading a team of Field Medical professionals. Direct reports will include field-based Regional Associate Directors (RADs) and Region Directors (RDs) who manage a team of field-based Immunology Medical Science Liaisons (MSLs) focused on Admilparant. The FM Director will be responsible for oversight of RADs/RDs and MSLs in support of BMS Immunology medicines, specifically Admilparant, and all phases of associated clinical trials and launch. Key Responsibilities - Ensure team’s ability to drive scientific exchange with Thought Leaders, appropriate HCPs, and access stakeholders. - Support and evaluate MSLs ability to effectively present information to HCPs and respond to questions. - Actively assess the medical landscape by meeting with Thought Leaders. - Understand the competitive landscape and prepare to address informational needs of customers. - Ensure MSLs capability to collect and provide meaningful medical insights. - Provide direction to overall execution of the Field Medical plan. - Ensure active support for CRO sponsored studies. - Oversee appropriate support of BMS sponsored and Interventional and Non-Interventional Research studies. - Enhance patient enrolment in BMS-sponsored clinical trials. - Oversee recommendations and insights to clinical development team on study and site feasibilities. - Ensure BMS Pharmacovigilance procedural documents are understood and applied. - Support MSL as a primary liaison to investigators interested in developing investigator-sponsored research. - Develop and oversee national Field Medical plan. - Actively participate in the cross-functional Medical Matrix Teams. - Provide Medical Support as necessary and appropriate. - Actively manage Regional Associate Directors and Region Directors. - Ensure compliance with all local laws and regulations as well as BMS policies and procedures. - Support employee development through coaching and direction. Qualifications - MD, PharmD, or PhD, with experience in Pulmonary Fibrosis or Science Graduate with relevant pharmaceutical experience. MBA a plus. - A minimum of 8+ years of clinical and/or pharmaceutical experience including a minimum of 6 years of FM experience. - Demonstrated ability to lead national field medical projects or initiatives. - Demonstrated ability in account management. - Experience working in cross-functional teams. - Experience coaching and mentoring within a FM organization. - In-depth knowledge of disease area, including key scientific publications. - Strong communication and presentation skills. Requirements - Clear understanding of customer (HCP and payer) and patient needs. - Knowledge of principles and implications of pharmacoeconomic data. - Knowledge of the US Healthcare System and the Pharmaceutical Industry. - Understanding of environmental and industry trends. - Knowledge of clinical trial design and relevant compliance standards. - Strong strategic thinking skills. Benefits - Health Coverage: Medical, pharmacy, dental, and vision care. - Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). - Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, and more. - Work-life benefits: Flexible time off, paid national holidays, and additional time off for various needs.
Role Description Across Medical Affairs, Pfizer Medical colleagues engage with healthcare professionals and other stakeholders to generate insights that inform medical strategy, evidence generation, and execution. The Director, Medical Insights plays a key role in advancing Pfizer’s Medical Insights capabilities by helping shape, implement, and continuously improve Medical Insights processes across Medical Affairs and the broader enterprise. The role serves as a subject matter expert for Medical Insights, partnering closely with: - Medical Engagement & Impact (MEI) - US Medical Affairs - Digital & Technology - Medical Systems - Other stakeholders A core focus of the role is to maximize the value and impact of Medical Insights by embedding them effectively into medical processes, strategic discussions, and decision-making, leveraging advanced analytics, artificial intelligence, and emerging technologies to translate complex medical data into actionable insights that support scalable, value-driven, and data-informed decisions across Pfizer’s portfolio of medicines. Qualifications - Bachelor’s degree or higher in Life Sciences, Biomedical Sciences, Pharmaceutical Sciences, Data Sciences, Data Analytics, or a related field. - 8+ years of relevant experience in the pharmaceutical or life sciences industry; 7+ with Masters; 5+ with PharmD/PhD. - Demonstrated experience in Medical Affairs, Medical Analytics, Medical Strategy, Medical Communications, Research & Development, or a related function. - Experience (3+ years) in analyzing, interpreting, and synthesizing data and insights. - Proven effectiveness operating in complex, cross-functional, matrixed, and global environments. - Strong interpersonal and communication skills. - Ability to partner effectively across cultures, regions, and organizational boundaries. - Solid understanding of the pharmaceutical and Medical Affairs operating environment. Requirements - Contribute to the development and evolution of Medical Insights strategies, frameworks, standards, and ways of working. - Drive alignment of Medical Insights approaches across Medical Affairs. - Participate in Medical Insights governance and planning forums. - Identify and help prioritize opportunities across the end-to-end Medical Insights lifecycle. - Define and refine Insights use cases and business questions. - Translate business needs into clear functional and data requirements. - Evaluate analytics and AI-enabled capabilities from a Medical perspective. - Guide the application of advanced analytics and AI-enabled approaches. - Embed Medical Insights into core Medical processes. - Define and monitor indicators of value and impact. - Enable effective use of Medical Insights platforms and tools. - Build strong, collaborative relationships across Medical Affairs and partners. Benefits - 401(k) plan with Pfizer Matching Contributions. - Paid vacation, holiday, and personal days. - Paid caregiver/parental and medical leave. - Health benefits including medical, prescription drug, dental, and vision coverage.
