Senior Director, Patient Safety & PV Science

Senior Director, Patient Safety & PV Science

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 Sr Director, Patient Safety & PV Science will report to the Head of Safety Science and is responsible for safety monitoring of assigned Corcept products (investigational and marketed). Core safety deliverables relate to safety governance, signal detection/management, and periodic and aggregate reporting. This role demonstrates a high level of strategic thinking and may take on a SME role for one or more PSPV processes.

The Sr Director collaborates with PSPV team members to manage key safety surveillance activities, safety analyses, risk management and safety document deliverables. This role also engages and collaborates cross‑functionally to execute on the corporate development strategy. This is a hybrid role, typically on‑site three days a week in Redwood City, CA.

• Develop and maintain strategies for signal detection and risk management across clinical and post‑marketing settings to monitor and define the safety profile for Corcept products.
• Lead proactive safety data reviews and analyses using appropriate data sources, including case series reviews, data summaries and/or AE trend evaluations.
• Collaborate with safety physicians on signal detection and risk management activities.
• Review medical and scientific literature to support signal detection and aggregate reporting.
• Provide safety input to statistical analysis plans, data analysis visualizations, and documents requiring in‑depth safety analysis to ensure consistent presentation of safety and risk management topics across regulatory documents.

• Create and maintain product core safety information, including risk management plans (RMPs) and company core data sheets (CCDSs).
• Lead the preparation and development of global periodic aggregate safety reports.
• Contribute to and review safety sections of clinical documents, including investigator’s brochure (IB), clinical study protocols, and clinical study reports.

• Facilitate cross‑functional safety governance activities to ensure alignment of safety strategy and decision‑making.
• Establish and maintain collaborative relationships with senior stakeholders across functions to support the development and execution of product safety strategies.

• Work closely with safety physicians and cross‑functional stakeholders to present safety data and provide expertise during key meetings (e.g., Health Authorities, Data Safety Monitoring Boards, Investigators).
• Lead or contribute to health authority or other safety related query responses for Corcept products.

• Coach and mentor team members in applying safety expertise across Corcept product development and lifecycle activities.
• Oversee PV vendor performance and drive continuous process improvement.

• Serve as a subject matter expert (SME) for relevant PSPV science processes.

• Ability to work in a dynamic environment to meet corporate and patient needs.
• Excellent working knowledge of Argus (or similar applications), MS Office applications, electronic data capture systems, and MedDRA and WHO Drug coding dictionaries.
• Excellent…