Senior Director, Clinical Trial Patient Safety Lead

The role

The Senior Director, Clinical Trial Patient Safety Lead provides strategic and operational leadership for clinical trial patient safety across the development portfolio. This role involves establishing an integrated operating model for study safety operations and safety data review.

What you will do

• 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

Required qualifications

• Advanced degree in medicine, pharmacy, nursing, or related discipline
• 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

Nice to have

• MD, PharmD, or equivalent advanced clinical/scientific degree

Before you apply

• Applicants must be currently authorized to work in the United States on a full-time basis

About the company

Corcept is focused on the science of cortisol to address diseases. The company is headquartered in Redwood City, California.