Senior Director, Clinical Trial Patient Safety Lead at Corcept Therapeutics in Redwood City, CA

Job description

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. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com . As Corcept's clinical development portfolio and international presence continue to expand, the Patient Safety & Pharmacovigilance (PSPV) organization is expanding its capabilities to support the company's growing pipeline of innovative medicines. We are seeking a talented and experienced leader to serve as Senior Director, Clinical Trial Patient Safety Lead and provide strategic and operational leadership for clinical trial patient safety across the development portfolio. The function includes two complementary areas: Study Management and Safety Data Review . The Senior Director will establish and scale an integrated operating model spanning study safety operations, CRO oversight, safety-data quality, ICSR quality oversight, data reconciliation, query management, data cleaning, and clinical safety data readiness. As a member of the PSPV Leadership Team, this leader will work closely across PSPV (Medical Safety, Safety Sciences, Postmarketing Safety Operations, Safety Systems, Business Operations, QPPVs, and Epidemiology), as well as Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs, Quality, and external CROs. Responsibilities: Lead the Clinical Trial Patient Safety organization across Corcept's global clinical development portfolio Establish a scalable operating model for clinical trial safety operations from study start-up through close-out Lead and develop the Study Management and Safety Data Review functions Establish effective CRO and vendor governance for delegated clinical safety activities Oversee clinical safety data-review strategy, reconciliation, data cleaning, and safety-data quality Establish a robust internal quality-oversight model for outsourced ICSR processing Ensure appropriate risk-based QC, including end-of-line, sample, targeted, and in-line review Partner closely with Biometrics to ensure integrated EDC and safety-database data quality Establish operational readiness for database locks, clinical development milestones, and regulatory submissions Lead development and maintenance of functional SOPs, procedures, and other operational standards Partner with Safety Systems to advance clinical safety technology and data capabilities Partner with PV Compliance, Business Operations, and Quality on the implementation of standards, training, audits, inspections, and operational readiness Build organizational capabilities and develop high-performing leaders and teams Contribute to PSPV strategy as a member of the PSPV Leadership Team Preferred Skills, Qualifications and Technical Proficiencies: Advanced degree in medicine, pharmacy, nursing, or related discipline is required; an MD, PharmD, or equivalent advanced clinical/scientific degree is preferred 14+ years of experience in clinical safety, pharmacovigilance, clinical operations, or related pharmaceutical/biotechnology functions Significant experience leading clinical trial safety operations across global clinical development programs Strong understanding of clinical safety data, ICSR operations, CRO oversight, and clinical development processes Experience with EDC, safety databases, reconciliation, data review, and data cleaning Demonstrated experience leading global or geographically distributed teams and managing CROs and external vendor