Senior Director, Postmarketing Safety Operations Lead

The function includes two complementary areas: Case Management Operations, Postmarketing Safety and External Engagement, Postmarketing Safety.

The Senior Director will provide strategic and operational leadership across global postmarketing safety case management and external safety-data channels, including case management vendors, specialty pharmacies, hubs, patient support programs, and other external partners. The role will build and scale the operating model, drive operational excellence, vendor performance, data quality, and continuous improvement, and develop the capabilities needed to support Corcept's expanding commercial and international footprint.

As a member of the PSPV Leadership Team, this leader will work closely across PSPV (Medical Safety, Safety Sciences, Epidemiology, Clinical Trial Patient Safety, Safety Systems, Business Operations, and QPPVs), as well as Commercial, Medical Affairs, Regulatory Affairs, Quality, and other functions across Corcept.

Responsibilities

• Lead global postmarketing safety operations supporting Corcept's marketed-product portfolio
• Lead and develop the Case Management Operations and External Engagement functions, establishing a cohesive global operating model
• Provide strategic oversight of global outsourced ICSR processing and vendor performance
• Establish effective operational processes across specialty pharmacies, hubs, patient support programs, and other external sources of safety information
• Build strong partnerships with international stakeholders and external service providers to support consistent, high-quality execution across markets
• Drive operational performance through meaningful KPIs, quality metrics, governance, and continuous improvement
• Lead development and maintenance of functional SOPs, procedures, and other operational standards
• Partner with Safety Systems to advance technology, automation, data integration, and digital capabilities supporting postmarketing safety
• Partner with PV Compliance, Business Operations, and Quality on the implementation of standards, training, audits, inspections, and operational readiness
• Partner with QPPVs to support effective international PV operations and oversight
• Support postmarketing safety readiness for regulatory submissions, inspections, product launches, and lifecycle activities
• Build organizational capabilities, develop talent, and foster a culture of accountability, collaboration, and quality
• Serve as a key member of the PSPV Leadership Team and contribute to broader PSPV strategy and organizational growth

Preferred Skills, Qualifications and Technical Proficiencies

• Bachelor's degree in pharmacy, nursing, or related discipline; advanced degree preferred
• 14+ years of patient safety/pharmacovigilance experience in pharmaceutical or biotechnology, with significant experience in postmarketing safety
• Strong leadership experience across global postmarketing safety operations, including ICSR case management and external safety-data channels
• Demonstrated experience leading global or geographically distributed teams and managing international vendors and service providers
• Strong understanding of global pharmacovigilance regulations, ICSR requirements, and postmarketing safety practices
• Experience building and scaling operating models, processes, and teams in a growing pharmaceutical or biotechnology organization
• Strong cross-functional leadership and ability to influence across functions, geographies, and external organizations
• Demonstrated strategic thinking, operational excellence, and ability to lead through growth, change, and increasing organizational complexity