Senior Medical Director, Product Safety Physician Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the Lead Product Safety Physician for multiple or large, intricate, strategically vital developmental programs.

• Supervise benefit/risk safety profiles of assigned products throughout their life cycle, particularly during early development.

• Recognize, manage, escalate, document, and communicate safety issues.

• Chair Safety Management Team meetings and represent the team at Company Safety Committee gatherings.

• Direct safety communications, labeling revisions, Company Core Safety Information, and associated regulatory documents.

• Head issue management, crisis response, regulatory inquiry strategies, and responses to regulatory bodies.

• Offer safety leadership for regulatory meetings, safety inquiries, serious adverse events, and escalated reports.

• Create safety differentiation strategies, train staff, review publications, and assist with in-licensing opportunities.

• Collaboratively draft and review safety content for clinical trial protocols, investigator brochures, informed consent documents, safety reports, and monitoring strategies.

• Analyze safety data, serious adverse events, abnormal lab results, aggregate analyses, and clinical trial safety outputs.

• Support clinical study reports, Summary of Clinical Safety, Integrated Summary of Safety, and 120-day updates.

• Advocate for and promote safety on product development teams and contribute to development strategy.

• Coordinate product activities across Global Patient Safety and oversee pharmacovigilance processes.

• Formulate Product Safety Strategies, Safety Surveillance Plans, Risk Management Plans, post-approval commitments, launch plans, publication strategies, and pharmacoepidemiology strategy.

• Assess processes against regulatory requirements and ensure inspection readiness.

• Mentor and train Safety Physicians and Safety Scientists.

• May supervise Safety Scientists and Physicians based on the program or portfolio.

⛳️ Requirements

• MD (or internationally recognized equivalent) along with an accredited residency.

• Over 6 years of experience in the pharmaceutical/biotechnology industry in Clinical Research and Clinical Development.

• At least 4 years of experience in safety during Phase 1 and Phase 2.

• Previous experience in matrix management teams.

• Prior experience as a product safety physician.

• Experience in pharmaceutical product development, including individual study design and filing strategies.

• Familiarity with global regulatory standards for pharmacovigilance.

• Relevant experience with Regulatory Agency and Key Opinion Leader interactions.

• Intermediate proficiency in using a safety database to retrieve safety information.

• Advanced knowledge of MedDRA.

• Strong skills in Excel, PowerPoint, and Word.

• Understanding of data mining and exploratory analysis tools such as Spotfire.

• Willingness to travel less than 10% of the time.

• Preferred: accredited fellowship with 1 year of clinical experience with patients in a relevant therapeutic specialty.

• Preferred: experience in oncology within the preapproval context.

🏝️ Benefits

• Eligibility for annual bonus plans for non-commercial roles.

• Discretionary equity awards.

• Option for voluntary participation in the Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) retirement plan.

• Flexible Spending Account/Health Savings Account.

• Life insurance coverage.

• Paid Time Off.

• Wellness benefits.

• Equal opportunity employer.

• Reasonable accommodations available during the application process.