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 portfolio and international presence continue to expand, the Patient Safety & Pharmacovigilance (PSPV) organization is expanding its capabilities to support the company's growing portfolio of innovative medicines. We are seeking a talented and experienced leader to serve as Senior Director, Postmarketing Safety Operations Lead and provide strategic and operational leadership for global postmarketing safety operations.
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
The pay range that the Company reasonably expects to pay for this headquarters-based position is $238,400 – $315,600; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.
Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at: https://www.corcept.com/
Corcept is an Equal Opportunity Employer
Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.
Skills Required
- Bachelor's degree in pharmacy, nursing, or a related discipline
- 14+ years of patient safety or pharmacovigilance experience in pharmaceutical or biotechnology organizations
- Significant experience in postmarketing safety
- Leadership experience across global postmarketing safety operations, including ICSR case management and external safety-data channels
- Experience leading global or geographically distributed teams
- Experience 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 and operational excellence
- Advanced degree
What We Do
Leading the field in the discovery of drugs that modulate the effects of cortisol. The adverse effects of excess cortisol have been Corcept’s focus since the company’s inception. Abnormal levels and release of cortisol play a role in a variety of metabolic, oncological, and psychiatric diseases, and we are currently studying a new generation of compounds that may mitigate the effects of excess cortisol.
