Global Safety Medical Director - Obesity

Role Summary

Global Safety Medical Director, Obesity, serves as the safety expert for the assigned development product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities and accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. You will also lead the Safety Analysis Team (SAT) and Global Safety Team (GST). In addition, you will participate as a member of the Evidence Generation Team and other relevant cross-functional teams and will be assigned as delegate for the Therapeutic Area Head (TAH) and have management of Global Safety Physicians.

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
• Prepare/review safety sections of new drug applications and other regulatory filings
• Serve as safety expert on Evidence Generation Team for assigned products
• Inspection Readiness
• Travel: Domestic and International travel ~10% may be required

Qualifications

• Required: MD or DO degree from an accredited medical school
• Required: Completion of an accredited medical or surgical residency
• Or: Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
• Required: 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
• Preferred: Industry pharmacovigilance (PV) experience
• Preferred: Product safety in the bio/pharmaceutical industry or regulatory agency
• Preferred: Previous management and/or mentoring experience
• Preferred: Board certification or equivalent training
• Preferred: Expertise in Obesity/Cardiovascular therapeutic area
• Preferred: Leadership experience within the safety profile of products assigned with cross-functional team members