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 benefit-risk assessments across clinical development and post-marketing programs.

• Operate as a peer functional leader alongside the Head of Safety Science, Head of Safety Operations, and QPPV(s) within the Patient Safety & Pharmacovigilance organization, partnering to provide strategic leadership, ensure effective governance, and maintain an integrated approach to patient safety and pharmacovigilance across the portfolio
• Partner with key internal stakeholders, including Clinical Development and Medical Affairs to ensure alignment of safety insights across the product lifecycle while maintaining independent medical judgment on safety and benefit-risk decisions

Responsibilities:

Medical Safety Leadership

• Define and drive the medical safety strategy across the portfolio
• Provide senior medical safety leadership for safety interpretation and benefit-risk assessment
• Ensure consistent medical oversight of clinical and post-marketing safety activities

Team Leadership

• 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

Safety Review & Surveillance

• Lead medical evaluation of safety signals in partnership with Safety Science
• Ensure robust benefit-risk assessment across programs
• Integrate clinical interpretation into safety surveillance outputs

Key Collaboration

• Partner with Clinical Development to integrate safety into development strategy
• Partner with Medical Affairs to ensure consistent safety messaging
• Provide medical interpretation and benefit-risk input to cross-functional decisions

Regulatory & Governance

• 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 benefit-risk input in cross-functional safety governance forums

Risk Management

• 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 benefit-risk 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 benefit-risk 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.

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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.

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