Senior Medical Director, Product Safety Physician Lead

About the role

BeOne is seeking a highly motivated and collaborative Senior Medical Director to serve as the Lead Product Safety Physician for multiple or large complex, strategically important developmental programs (often multi-indication). This role is responsible for creating and maintaining a single interpretation of global safety data for developmental products and ensuring patient safety in BeOne-sponsored studies.

Responsibilities

• Oversee the benefit/risk safety profile of allocated products through the product life cycle, with a focus on early development.
• Lead and enhance knowledge of safety profiles for allocated products, including both BeOne and competitor products.
• Identify and manage safety concerns for developmental and approved BeOne products.
• Lead Development and Medical Affairs product teams in handling product safety concerns.
• Chair Safety Management Team (SMT) meetings, review materials, and represent the safety perspective.
• Participate in Company Safety Committee (CSC) meetings, propose agenda items, and communicate recommendations to stakeholders.
• Actively participate in External Safety Monitoring Committees (DMC) and Internal Safety Monitoring Committees (SMC).
• Lead the development and maintenance of the Company Core Safety Information (CCSI) and propose edits for approval.
• Provide safety insights for labeling updates, including Package Insert and Company Core Data Sheet (CCDS).
• Lead issue management, including escalation, strategy development, and response documentation for regulatory inquiries.
• Lead responses to regulatory agencies and incorporate updates from pharmacovigilance and epidemiological analysis.
• Guide medical review of Serious Adverse Events (SAEs) and provide input for escalation as needed.
• Develop strategic plans for safety differentiation of BeOne products and provide training on product safety profiles.
• Collaborate with cross-functional teams (Legal, Business Development, Operations, Marketing) to communicate safety data and interpretation.
• Author safety content in clinical trial documentation, including protocols, Investigator’s Brochures (IBs), and Informed Consent Forms (ICFs).
• Review and advise on safety endpoints, inclusion/exclusion criteria, and risk monitoring in trial design.
• Develop and maintain Risk Summary Information (RSI) and contribute to safety sections of the Development Safety Update Report (DSUR).
• Lead the formulation of safety criteria and review study-specific medical monitoring plans.
• Review and interpret study safety data, support Clinical Study Report narrative generation, and draft safety sections of regulatory filings.
• Lead the preparation of safety sections for the Summary of Clinical Safety and Integrated Summary of Safety (ISS).
• Represent safety at product development teams and contribute to development strategy.
• Lead Global Patient Safety (GPS) product coordination, chair product group meetings, and manage pharmacovigilance processes.
• Develop Product Safety Strategy, Safety Surveillance Plans, and Risk Management Plans (RMPs).
• Define events of interest, manage post-approval commitments (PAC), and develop product launch plans.
• Evaluate current processes for alignment with regulatory expectations and lead continuous improvement initiatives.
• Train and mentor Safety Physicians and Safety Scientists.

Qualifications

• MD (or internationally recognized equivalent) plus accredited residency.
• 6+ years of pharmaceutical/biotechnology industry experience in Clinical Research and Clinical Development, with 4+ years in safety for Phase 1 and Phase 2.
• Accredited fellowship with 1-year clinical experience in a relevant therapeutic area (oncology preferred).
• Experience in oncology in the pre-approval space is preferred.
• Prior matrix management team experience and experience as a product safety physician.
• Pharmaceutical product development experience, including individual study design and filing plans.
• Experience with global regulatory requirements for pharmacovigilance and interactions with Regulatory Agencies and Key Opinion Leaders (KOLs).

Supervisory Responsibilities

This position may have safety scientists/physicians reporting to them, depending on the program or portfolio being led. The Senior Medical Director works closely with other Safety Science and Epidemiology Physicians and Safety Scientists as part of a flexible matrix team.