Global Safety Medical Director, Hematology Oncology

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the safety authority for the designated product(s) within the Hematology Oncology portfolio.

• Formulate the strategy, direction, and priorities for pharmacovigilance initiatives.

• Lead the Safety Analysis Team (SAT), Global Safety Team (GST), and participate as a core member of the Executive Safety Committee (ESC).

• Validate safety signals and oversee safety signal evaluations.

• Create and maintain Core Safety Information, including core data sheets and core risks in informed consent documents.

• Prepare and review core and regional risk management strategies that include additional risk minimization measures.

• Provide safety-related input for protocols, statistical analysis plans, and clinical study reports.

• Prepare and review safety sections of new drug applications and other regulatory submissions.

• Serve as the safety expert on the Evidence Generation Team for the assigned products.

• Operate in a fast-paced setting alongside a dynamic team of safety physicians and scientists.

⛳️ Requirements

• MD or DO degree from an accredited medical institution AND completion of an accredited medical or surgical residency OR relevant clinical experience in an accredited academic or private practice environment (including hospital settings).

• Experience in product safety within the bio/pharmaceutical industry or regulatory agencies.

• Proficiency in the Hematology Oncology therapeutic area, or relevant clinical training.

• Background in marketed product safety and risk management.

• Familiarity with safety assessments and analyses for phase 1-3 clinical trials.

• Experience with drug submissions.

• Leadership experience overseeing the safety profiles of assigned products in collaboration with cross-functional team members.

🏝️ Benefits

• A comprehensive employee benefits package, which includes a Retirement and Savings Plan with substantial company contributions.

• Group medical, dental, and vision insurance.

• Life and disability coverage.

• Flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.

• Stock-based long-term incentive opportunities.

• Award-winning time-off policies.

• Flexible work arrangements, including remote and hybrid options when feasible.