Global Safety Medical Director – Global Safety Officer, Oncology

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

📋 Description

• Serve as the safety authority for the assigned product(s), defining the strategy, direction, and priorities of pharmacovigilance initiatives.

• Responsible for the comprehensive safety profile and all product-related decisions and outputs for the designated products.

• Direct the Safety Analysis Team (SAT), lead the Global Safety Team (GST), and serve as a key member of the Executive Safety Committee (ESC).

• Evaluate product safety profiles, assess benefit-risk ratios, and manage risk communication.

• Develop the Clinical Trial Safety Brochure and Informed Consent Form.

• Oversee new drug applications and various regulatory submissions.

• Implement risk management strategies and mitigation plans.

• Engage in the commercialization process.

• Ensure readiness for inspections.

• Collaborate on partnerships and integration initiatives.

• Contribute to the development and review of safety agreements.

• Compile safety information to assist licensing partners, review safety documents prepared by them, and maintain communication on safety issues in accordance with the safety agreement.

⛳️ Requirements

• Possession of an MD or DO degree from an accredited medical institution.

• Completion of an accredited medical or surgical residency OR clinical experience in either an accredited academic or private practice (including hospital-based) environment.

• A minimum of 2 years of experience in industry Global Safety.

• Background in oncology, particularly in early development.

• Experience with product safety in the biopharmaceutical industry or regulatory agencies.

• Prior management and/or mentoring experience.

• Familiarity with oncology products and early development processes.

🏝️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.