Senior Medical Director Drug Safety Oncology

We are seeking an experienced Senior Medical Director to lead medical safety activities for assigned drug projects, providing expertise in clinical development and driving risk management initiatives in accordance with global regulatory standards. This position will involve continuous safety data monitoring, signal detection, and benefit-risk evaluation for compounds in clinical development and post-market use.

Key Responsibilities:

• Lead safety activities, signal detection, and risk management for assigned products.
• Provide medical safety guidance across clinical trial teams and cross-functional projects.
• Oversee case narratives, signal evaluations, and periodic safety reports.
• Ensure compliance with regulatory safety reporting and risk management practices.
• Collaborate with external vendors and regulatory authorities, and support inspections and audits.

Qualifications:

• Medical Degree (MD, DO, MBBS) required; experience in clinical settings.
• 10+ years in drug safety or clinical trials, with 6+ years in the industry; oncology experience preferred.
• Strong leadership and communication skills, with expertise in pharmacovigilance and regulatory requirements.
• Ability to work independently and mentor junior team members.