Job Description

The Senior Medical Director, Clinical Safety will provide strategic medical safety leadership for benefit-risk assessments of investigational products, with a particular focus on a key biologic asset in development for one of the company's leading products. Operating within a matrixed environment, this role oversees safety-related activities across the clinical development portfolio, including signal detection, risk evaluation, mitigation planning, and aggregate safety reporting.

This position also leads the medical review of safety content in clinical documentation such as study protocols, investigator brochures, clinical study reports, product labeling, and regulatory responses.

Additionally, the Senior Medical Director will manage a global team of pharmacovigilance professionals dedicated to clinical development safety activities.

• Develop and maintain Development Risk Management Plans (DRMPs) to proactively minimize risks during clinical trials.
• Collaborate with internal and external stakeholders to monitor safety profiles, validate and evaluate safety signals, and recommend appropriate risk mitigation strategies.
• Lead the preparation and submission of aggregate safety reports (e.g., DSURs, PSURs, PBRERs).
• Own the development and maintenance of Risk Management Plans (RMPs).
• Provide expert input into safety sections of regulatory dossiers and contribute to responses to safety-related inquiries from health authorities and other stakeholders.
• Participate in investigator and key opinion leader (KOL) meetings to address safety-related topics.
• Oversee ongoing safety data review during clinical trials through structured Safety Plans and regular safety review meetings.

• M.D. required; additional qualifications in Clinical Pharmacology, Public Health, Epidemiology, or Pharmacovigilance preferred.
• Minimum of 12 years of experience in drug development, clinical safety, or pharmacovigilance within a global pharmaceutical organization.
• At least 3-5 years of experience managing teams of safety physicians or scientists.
• Deep understanding of international clinical development and post-marketing safety regulations, particularly for biologics.
• Proven experience interacting with global health authorities on safety-related matters (e.g., RMPs, Clinical Overviews).
• Strong knowledge of global safety requirements across the product life cycle.

Job Tags

Similar Jobs