Lead Medical Safety Physician

Lead Medical Safety Physician

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.

Reporting to the Vice President, Head of Patient Safety & Pharmacovigilance, this role will be responsible for leading the Medical Safety Physician function, ensuring the quality, consistency, and medical integrity of safety assessments across the portfolio. The individual will provide oversight of medical review, signal evaluation, and benefitrisk assessments across clinical development and post-marketing programs.

Responsibilities:

• Define and drive the medical safety strategy across the portfolio
• Provide senior medical safety leadership for safety interpretation and benefitrisk assessment
• Ensure consistent medical oversight of clinical and post-marketing safety activities
• Lead, build, and develop a team of Medical Safety Physicians
• Set standards for medical review quality and consistency
• Scale the organization to support portfolio and geographic growth
• Lead medical evaluation of safety signals in partnership with Safety Science
• Ensure robust benefitrisk assessment across programs
• Integrate clinical interpretation into safety surveillance outputs
• Partner with Clinical Development to integrate safety into development strategy
• Partner with Medical Affairs to ensure consistent safety messaging
• Provide medical interpretation and benefitrisk input to cross-functional decisions
• Oversee medical input into DSURs, PADERs, and regulatory safety submissions
• Support health authority interactions and safety queries
• Contribute to cross-functional safety governance forums, providing medical expertise and benefitrisk input in cross-functional safety governance forums
• Identify and escalate safety risks at product and portfolio level
• Define medical risk mitigation strategies with cross-functional partners
• Drive continuous improvement in medical safety processes and standards

Preferred Skills, Qualifications and Technical Proficiencies:

• MD required; board certification in a relevant specialty strongly preferred
• 12+ years of progressive leadership experience in the pharmaceutical or biotechnology industry, including significant experience in Medical Safety and pharmacovigilance; oncology experience required
• Demonstrated success leading Medical Safety organizations and managing teams of Medical Safety Physicians
• Deep expertise in safety signal management, medical review, aggregate safety assessment, and benefitrisk evaluation across clinical development and post-marketing products
• Extensive experience interacting with global health authorities and leading safety-related regulatory activities
• Strong understanding of global pharmacovigilance regulations and industry best practices
• Proven ability to influence cross-functional and executive-level decision-making and build effective partnerships across Patient Safety/Pharmacovigilance, Clinical Development, Regulatory Affairs, Medical Affairs and Biometrics
• Experience building, scaling, or leading Medical Safety functions in fast-paced or growing organizations preferred

Preferred Education and Experience:

• Strategic medical leadership and executive presence
• Clinical judgment and benefitrisk decision-making
• Medical governance and patient safety leadership
• Cross-functional influence and stakeholder management
• Organizational leadership, talent development, and succession planning
• Regulatory/ health authority engagement
• Executive communication and presentation skills
• Driving organizational change and continuous improvement

The pay range that the Company reasonably expects to pay for this headquarters-based position is $298,000 $350,600; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must be currently authorized to work in the United States on a full-time basis.

Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.