Global Safety Director, Obesity – US, Remote

Role Summary

Location: US-based, remote. The Global Safety Director for Obesity is responsible for the safety strategy, direction, and prioritization of pharmacovigilance activities for assigned products, ensuring the overall safety profile and regulatory deliverables. You will lead the Safety Analysis Team (SAT), Global Safety Team (GST), and serve as a core member of the Executive Safety Committee, working with cross-functional partners to bring therapies to market. This role requires leadership in safety signal validation, risk management, and regulatory filings.

Responsibilities

• Validate safety signals and lead safety signal assessments
• Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
• Prepare/review core and regional risk management plans including additional risk minimization measures
• Prepare/review safety sections of periodic aggregate reports
• Provide safety input to protocols, statistical analysis plans, and clinical study reports
• Author /review and strategize safety sections of new drug applications and associated documents and other regulatory filings
• Serve as safety expert on Evidence Generation Team for assigned products
• Inspection Readiness
• Domestic and International travel up to 10%

Qualifications

• Required: Doctorate degree and 4 years Safety experience
• OR: Master’s degree and 7 years Safety experience
• OR: Bachelor’s degree and 9 years Safety experience
• Preferred: Product safety in the bio/pharmaceutical industry or regulatory agency
• Preferred: Expertise in Obesity, Metabolic/CV therapeutic area, or clinical training
• Preferred: Experience with marketed product safety; risk management
• Preferred: Experience with phase 1-3 clinical trials safety assessments and analyses
• Preferred: Drug Submission experience (preferably multiple new drug submission experience) and regulatory interactions
• Preferred: Leadership experience of the safety profile of products assigned with cross-functional team members

Skills

• Preferred: Product safety in the bio/pharmaceutical industry or regulatory agency
• Preferred: Expertise in Obesity, Metabolic/CV therapeutic area, or clinical training
• Preferred: Experience with marketed product safety; risk management
• Preferred: Experience with phase 1-3 clinical trials safety assessments and analyses
• Preferred: Drug Submission experience (multiple new drug submissions) and regulatory interactions
• Preferred: Leadership experience of the safety profile of products assigned with cross-functional team members