Associate Director, Clinical Records

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.

In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome).

Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.

What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.

The Associate Director, Clinical Records will provide strategic leadership and oversight for Corcept’s Trial Master File (TMF) management processes across all clinical programs. This individual will be accountable for the governance, quality, compliance, and inspection readiness of clinical documentation from study start-up through final archival. As a subject matter expert in eTMF operations and Veeva Vault, the Associate Director will drive innovation, ensure consistency across programs, and partner cross-functionally to support inspection readiness and regulatory compliance.

This role requires a proactive and collaborative leader with a strong command of global TMF best practices, system optimization, and strategic planning within a GCP-regulated environment.

Responsibilities:

• Provide strategic oversight and governance by leading the development and continuous improvement of TMF strategies, standards and procedures across all clinical programs
• Define and execute the long-term vision for clinical records and eTMF infrastructure, including risk mitigation, scalability and compliance
• Provide leadership and cross-functional collaboration by serving as the enterprise-wide TMF subject matter expert, offering guidance to clinical study teams, Quality Assurance and Regulatory Affairs
• Act as the primary TMF liaison during audits and inspections, ensuring readiness and addressing findings through corrective actions and continuous process improvement
• Collaborate with study teams to proactively manage TMF quality, regulatory compliance and inspection preparedness
• Establish and monitor KPIs and metrics to ensure ongoing TMF completeness, accuracy and timeliness; escalate risks and drive resolution
• Implement quality control measures, periodic reviews and oversight mechanisms to ensure compliance with global and local regulatory requirements
• Provide Veeva Vault oversight and system optimization by leading the configuration and lifecycle management of Corcept’s Veeva Vault eTMF system
• Oversee vendor and license management, user training, validation activities and system upgrades in partnership with IT and QA
• Develop and maintain TMF-related SOPs, policies and work instructions aligned with ICH-GCP, the DIA Reference Model and evolving regulatory expectations
• Design and deliver training programs to internal staff and external partners to ensure alignment with Corcept’s TMF processes and standards
• Identify and implement process enhancements and technology solutions to streamline document workflows and support clinical development goals
• Stay current with industry trends and regulatory developments to evolve Corcept’s TMF strategies and ensure continuous inspection readiness

Preferred Skills, Qualifications and Technical Proficiencies:

• Deep expertise in Veeva Vault eTMF, including configuration, reporting and system administration
• Strong knowledge of DIA Reference Model, ICH-GCP and global regulatory requirements for clinical documentation
• Demonstrated success in leading cross-functional initiatives, driving compliance and supporting regulatory inspections
• Excellent skills in project management, stakeholder engagement and process improvement
• Strategic thinker with strong analytical skills and a collaborative leadership style

Preferred Education and Experience:

• 8+ years of experience in clinical records management with at least 3 years in a leadership or strategic role

The pay range that the Company reasonably expects to pay for this headquarters-based position is $185,000 - $205,600; 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 th