Senior Medical Director, Therapeutic Area Safety Physician - Oncology and Neurology

The role

The Senior Medical Director provides senior medical safety leadership for assigned therapeutic areas during clinical development and post-marketing activities. This role provides strategic medical oversight of safety surveillance, safety analyses, emerging safety issues, and benefit-risk assessment.

What you will do

• Provide medical safety leadership across clinical development and post-marketing activities
• Develop and execute medical safety strategies aligned with program development plans
• Provide independent medical assessment of emerging safety information and potential risks
• Identify and communicate important safety issues and trends to governance bodies
• Lead signal detection, validation, evaluation, and ongoing safety surveillance
• Lead medical safety input into ongoing benefit-risk assessments
• Provide safety expertise for protocol design, eligibility criteria, and dose selection
• Partner with Clinical Development, Medical Affairs, Regulatory, and other functions
• Provide medical safety leadership for DSURs, PADERs/PBRERs, and regulatory submissions
• Provide leadership, coaching, and mentoring to Medical Safety Physicians

Required qualifications

• MD or equivalent medical degree
• 10+ years of relevant experience in the biotechnology or pharmaceutical industry
• Substantial experience in pharmacovigilance, drug safety, or medical safety
• Extensive experience providing strategic medical safety oversight across clinical development and/or post-marketing programs
• Strong experience in medical case review, signal evaluation, safety surveillance, and benefit-risk assessment
• Demonstrated experience providing medical safety leadership within one or more therapeutic areas
• Demonstrated experience supporting NDA and/or MAA filings
• Strong understanding of global pharmacovigilance regulations and safety requirements
• Experience contributing to regulatory submissions and health authority interactions
• Demonstrated leadership, mentoring, and/or people management experience

Nice to have

• board certification
• Experience in a growing biotechnology or pharmaceutical organization

About the company

Corcept is focused on the science of cortisol to address diseases. The company is headquartered in Redwood City, California.