Senior Medical Director, Product Safety Physician Lead

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Medical Director, Product Safety Physician Lead based in the United States.

This senior medical leadership role serves as the Product Safety Physician Lead for multiple or strategically important developmental programs, often spanning multiple indications. You will provide scientific and medical leadership across the product lifecycle, with a strong focus on early development and patient safety. The role is responsible for establishing an integrated global interpretation of safety data and guiding benefit-risk assessments. You will work across Clinical Development, Medical Affairs, Pharmacovigilance, Regulatory, Epidemiology, and other cross-functional teams. The position combines strategic leadership, regulatory engagement, safety governance, and hands-on medical review in a highly collaborative matrix environment. You will also mentor safety professionals and help strengthen organizational capabilities, processes, and standards. This is an opportunity to influence critical development decisions and help advance innovative therapies for patients with serious diseases.

Accountabilities:: 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.

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