Senior Director, Global Safety Physician

Role Summary

Senior Director, Global Safety Physician responsible for patient safety in clinical studies and marketed products, including ongoing safety data assessment, signal detection, and benefit–risk evaluation. Leads clinical safety strategy, authors and reviews safety documents, and supports regulatory interactions.

Responsibilities

• Medical oversight for clinical safety signals from trials, spontaneous reports, and literature.
• Lead or participate in safety signal detection, evaluation, validation, and documentation with safety scientists and stakeholders.
• Chair or key member of Safety Management Teams, contributing to benefit‚Äìrisk assessments and mitigation strategies.
• Author or medically review safety content in DSURs, PBRERs, RMPs, IBs, and safety sections of clinical study reports; provide input for INDs/NDAs/BLAs and safety responses to agency queries; support inspection readiness.
• Collaborate with Clinical Development, Biostats, Regulatory Affairs to align on safety strategy; work with PV Operations, Safety Data Management, and Medical Review teams to ensure quality of safety evaluations; participate in Safety Review Committees and risk boards.

Qualifications

• Deep knowledge of GCP, ICH E2E, GVP modules, and global regulatory safety expectations.
• Proven leadership across Phase I‚ÄìIV studies and familiarity with post-marketing surveillance.
• Experience with safety database systems (e.g., Argus, ArisGlobal), MedDRA, and safety signal detection tools.
• Experience in a matrixed global environment; specialty training in relevant therapeutic areas is a plus.
• Excellent strategic thinking, problem-solving, and influencing skills; strong regulatory interaction experience with FDA/EMA/PMDA.
• MD or equivalent medical degree with licensure or eligibility; 15+ years of relevant industry experience in clinical safety or pharmacovigilance.

Skills

• Senior-level leadership and communication; strategic thinking; risk-benefit evaluation.
• Decision-making under uncertainty; cross-functional influence; executive briefing and board-level updates.
• Strong verbal and technical writing skills; ability to present using scientific/regulatory terminology; fluent in English.

Education

• MD or equivalent medical degree with licensure or eligibility.
• 15+ years of relevant experience in industry, clinical safety, pharmacovigilance, or related roles.