Senior Medical Director, Product Safety Physician Lead

• Serve as the Product Safety Physician Lead for multiple or large, complex, and strategically important developmental programs, establishing and maintaining a unified global interpretation of product safety data.
• Lead benefit-risk oversight throughout the product lifecycle, with particular emphasis on early-stage development and proactive identification and management of emerging safety concerns.
• Chair Safety Management Team meetings, develop and communicate safety perspectives, review meeting materials, and represent product safety considerations to senior governance bodies.
• Represent assigned programs at Company Safety Committee meetings and contribute to meeting preparation, agenda development, recommendations, and follow-up actions.
• Participate in external and internal safety monitoring committees, providing medical interpretation of safety data, leadership, recommendations, and input into committee charters.
• Lead communication of safety recommendations to labeling teams and other relevant stakeholders, including development and maintenance of Company Core Safety Information and related labeling materials.
• Lead product safety issue management, including escalation, risk assessment, response strategy, regulatory inquiries, issue documentation, crisis response planning, and communication with internal and external stakeholders.
• Review and guide responses to regulatory agency inquiries, contributing to formal responses and participating in regulatory meetings as the safety representative.
• Provide medical review and escalation guidance for serious adverse events and other safety reports, determining when additional evaluation or escalation is required.
• Collaborate on clinical trial design and documentation, including protocols, Investigator's Brochures, informed consent materials, safety monitoring plans, and risk management strategies.
• Define and oversee safety data requirements, endpoints, inclusion and exclusion considerations, medical monitoring criteria, and safety-related elements of clinical data management plans and case report forms.
• Lead interpretation of ongoing clinical safety data, including serious adverse events, laboratory abnormalities, aggregate safety analyses, and protocol-specific surveillance activities.
• Provide safety input into Clinical Study Reports, Summary of Clinical Safety documents, Integrated Summary of Safety materials, Development Safety Update Reports, and regulatory filing activities.
• Develop and maintain Product Safety Strategies, Safety Surveillance Plans, Risk Management Plans, events of interest, product safety profiles, and related pharmacovigilance documentation.
• Lead safety assessments of internal, external, healthcare professional, and consumer inquiries, determining data requirements and overseeing appropriate responses.
• Monitor competitor safety profiles, labeling, public information, and emerging safety findings to support strategic product safety decisions.
• Support commercialization activities by providing safety expertise to Legal, Business Development, Operations, Marketing, and other functions, including review of publications and external-facing materials.
• Provide product safety training and guidance to employees and country medical teams and support consistent interpretation of safety information across global markets.
• Partner with Development and Medical Affairs teams to integrate safety considerations into product strategy, differentiation, development planning, and launch activities.
• Collaborate with Pharmacovigilance, Safety Science, Epidemiology, Regulatory, Clinical, and other functions to conduct robust safety assessments in accordance with applicable ICH standards and regulatory expectations.
• Lead or contribute to continuous improvement initiatives, process evaluations, inspection readiness, standards, training, and safety organization development.
• Mentor and develop Safety Physicians and Safety Scientists, providing technical guidance, coaching, and support to strengthen team capabilities.
• Maintain effective relationships with Regulatory Agencies, Key Opinion Leaders, internal stakeholders, and external partners as required.
• Promote a culture centered on patient safety, collaboration, scientific rigor, accountability, continuous learning, and operational excellence.

Requirements

• MD or internationally recognized equivalent with an accredited residency is required.
• At least 6 years of pharmaceutical or biotechnology industry experience spanning Clinical Research and/or Clinical Development, including 4+ years of safety experience in Phase 1 and Phase 2 development.
• Prior experience serving as a Product Safety Physician with responsibility for developmental product safety and risk management.
• Demonstrated pharmaceutical product development experience, including individual study design, safety strategy, and regulatory filing planning.
• Strong knowledge of global pharmacovigilance requirements, safety regulations, and applicable ICH standards.
• Experience interacting with Regulatory Agencies and Key Opinion Leaders and representing safety perspectives in external discussions.
• Experience working within complex matrix organizations and leading cross-functional teams across multiple functions and geographies.
• Oncology experience, particularly in the pre-approval development environment, is strongly preferred.
• An accredited fellowship and at least one year of clinical patient experience in a relevant therapeutic specialty is preferred, together with strong general medical knowledge.
• Demonstrated expertise in safety signal identification, issue assessment, benefit-risk evaluation, safety surveillance, and risk management.
• Strong knowledge of clinical trial safety requirements, including safety endpoints, monitoring strategies, dose escalation considerations, adverse event assessment, and aggregate safety analyses.
• Experience supporting regulatory submissions, safety reporting, labeling activities, DSURs, clinical safety reports, and related development documentation.
• Intermediate experience using safety databases to retrieve safety information and advanced knowledge of MedDRA.
• Advanced proficiency with Microsoft Office, particularly Excel, PowerPoint, and Word.
• Familiarity with data-mining and exploratory analysis tools such as Spotfire is preferred.
• Strong analytical and data interpretation capabilities, with the ability to translate complex safety information into clear recommendations and decisions.
• Excellent communication, presentation, influencing, and stakeholder-management skills, with the ability to communicate clearly with senior leaders and cross-functional teams.
• Strong leadership, mentoring, coaching, and matrix-management capabilities.
• Demonstrated ability to operate with initiative, sound judgment, adaptability, scientific curiosity, and a results-oriented mindset.
• Commitment to patient-focused decision-making, collaborative leadership, continuous improvement, and inclusive ways of working.
• Ability to travel occasionally, with expected travel of less than 10%.

Benefits

• Annual base salary: $298,200–$368,200, with actual compensation determined by skills, experience, education, certifications, training, and work location.
• Eligibility for an annual bonus plan for non-commercial roles.
• Eligibility for discretionary equity awards and participation in an Employee Stock Purchase Plan.
• Medical, dental, and vision insurance.
• 401(k) retirement savings plan.
• Flexible Spending Account (FSA) and Health Savings Account (HSA) options.
• Life insurance coverage.
• Paid time off.
• Wellness programs and resources.
• Fully remote opportunity within the United States.
• Senior-level exposure to global product development, safety governance, and regulatory strategy.
• Opportunity to influence the safety and development strategy of important therapeutic programs.
• Collaboration with multidisciplinary experts across Clinical Development, Pharmacovigilance, Regulatory, Epidemiology, Medical Affairs, and other functions.
• Leadership and mentoring opportunities supporting the growth of Safety Physicians and Safety Scientists.
• A mission-driven environment focused on improving patient safety and advancing innovative treatments for serious diseases.