Executive Medical Director, Product Safety Physician Lead

Role Summary

The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs and creates and maintains a single interpretation of global safety data for developmental and marketed products. They identify and manage safety concerns with Safety Physicians and Safety Scientists, ensuring patient safety in BeiGene-sponsored studies and products.

Responsibilities

• Accountable for oversight of benefit/risk safety profile of allocated products through the product lifecycle
• Actively leads and enhances knowledge of safety profiles for allocated products, including BeiGene and competitor products
• Identifies and leads management of safety concerns for developmental and approved BeiGene products
• Leads Development and Medical Affairs product teams in identifying and handling product safety concerns
• Chairs Safety Management Team meetings, reviews SMT materials, and represents safety perspectives in SMT meetings
• Represents the SMT and participates in Company Safety Committee meetings, supports meeting preparations, and proposes review topics
• Leads communication of safety recommendations to labeling groups and other stakeholders
• Participates in External Safety Monitoring Committee meetings and provides safety data, insights, and leadership
• Leads Internal Safety Monitoring Committee meetings and contributes to SMC charters

Qualifications

• Required: MD (or internationally recognized equivalent) plus accredited residency, with 10+ years in the pharmaceutical/biotechnology industry in Clinical Research/Clinical Development, including at least 6 years in pharmacovigilance
• Preferred: Accredited fellowship with 1 year of clinical experience in a relevant therapeutic area and substantial knowledge of general medicine
• Global Competencies include teamwork, feedback, self-awareness, inclusivity, initiative, continuous learning, adaptability, results-orientation, analytical thinking, financial acumen, and clear communication

Education

• MD (or internationally recognized equivalent) plus accredited residency, with 10+ years pharmaceutical/biotechnology industry experience in Clinical Research, Clinical Development with at least 6 years in pharmacovigilance. Accredited fellowship with 1-year clinical experience with patients in a relevant therapeutic area specialty is preferred

Skills

• Product safety strategy development and maintenance
• Safety data interpretation and communications for internal and external stakeholders
• Regulatory and labeling collaboration
• Issue management and crisis response planning
• Pharmacovigilance processes and safety surveillance planning