Senior Director, Clinical Trial Patient Safety Lead

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 vendors
• Strong leadership, organizational-building, and cross-functional collaboration skills
• Ability to build scalable capabilities and lead effectively through portfolio growth and increasing organizational complexity