The Sr Director, Patient Safety & PV Science will report to the Head of Safety Science and is responsible for safety monitoring of assigned Corcept products (investigational and marketed), with core safety deliverables related to safety governance, signal detection/management, and periodic and aggregate reporting. This role demonstrates a high level of strategic thinking and may take on a SME role for one or more PSPV process. The Sr Director collaborates with PSPV team members to manage key safety surveillance activities, safety analyses, risk management and safety document deliverables. This role also engages and collaborates cross-functionally to execute on the corporate development strategy.
Responsibilities:Safety Data Analysis & Signal Detection:
- Develop and maintain strategies for signal detection and risk management across clinical and post-marketing settings to monitor and define the safety profile for Corcept products
- Lead proactive safety data reviews and analyses using appropriate data sources, including case series reviews, data summaries and/or AE trend evaluations
- Collaborate with safety physicians on signal detection and risk management activities
- Review of medical and scientific literature to support signal detection and aggregate reporting
- Provide safety input to statistical analysis plans, data analysis visualizations, and documents requiring in-depth safety analysis to ensure consistent presentation of safety and risk management topics across regulatory documents
Safety Documentation & Reporting:
- Create and maintain product core safety information, including risk management plans (RMPs) and company core data sheets (CCDSs)
- Lead the preparation and development of global periodic aggregate safety reports
- Contribute to and review safety sections of clinical documents, including Investigator's brochure (IB), clinical study protocols, and clinical study reports
Cross-Functional Collaboration:
- Facilitate cross-functional safety governance activities to ensure alignment of safety strategy and decision-making
- Establish and maintain collaborative relationships with senior stakeholders across functions to support the development and execution of product safety strategies
Regulatory & External Engagement:
- Work closely with safety physicians and cross-functional stakeholders to present safety data and provide expertise during key meetings (e.g., Health Authorities, Data Safety Monitoring Boards, Investigators)
- Lead/contribute to health authority or other safety related query responses for Corcept products
Leadership & Team Development:
- Coach and mentor team members in applying safety expertise across Corcept product development and lifecycle activities
- Oversee PV vendor performance and drive continuous process improvement.
Inspection Readiness:
- Serve as a subject matter expert (SME) for relevant PSPV Science processes
Preferred Skills, Qualifications and Technical Proficiencies: - Ability to work in a dynamic environment to meet corporate and patient needs
- Excellent working knowledge of Argus (or similar applications), MS Office applications, electronic data capture systems, and MedDRA and WHO Drug coding dictionaries
- Excellent presentation, communication, and collaboration skills
- In-depth knowledge of global PV regulations and guidelines (e.g., ICH, GVP, FDA, EMA)
- Demonstrated success in taking the initiative in a team setting. Comfortable with ambiguity yet self-motivated and timeline driven
Preferred Education and Experience: - PhD, PharmD or other advanced degree in related discipline is preferred. Other relevant experience may be considered without an advanced degree; BS/BA degree in related discipline is required. Training or equivalent experience in epidemiology or public health is beneficial but not required
- 8+ years in patient safety and pharmacovigilance in the capacity of a scientist with a focus in the post-approval setting; at least 4 years of clinical development experience is required
- Related experience should include 2 or more years of supervisory/management experience in a matrix and geographically dispersed pharmaceutical/biotechnology organization
- Authoring and review of periodic and ad hoc safety reports (more than 5 years of experience required in safety or clinical documents such as PSURs, DSURs, Clinical Overviews, Clinical Study Reports or summaries)
- Strong medical science analytical reasoning skills with experience in the principles and techniques of data analysis, proficient in data analysis software and data presentation, interpretation, and relevance
- Experience in writing safety analysis, performing signal detection or safety surveillance, risk management and preparing responses to HA
- Working knowledge of industry standard pharmacovigilance data systems (e.g., Oracle Argus, data analytics, and signal management tools)
- Experience with NDA or MAA filing
- Endocrinology experience a plus
The pay range that the Company reasonably expects to pay for this 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.
