Senior Director, Patient Safety & PV Science

Corcept Therapeutics•Redwood City, CA

12d•$298,000 - $315,000•Hybrid

About The Position

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. 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. This is a hybrid role, typically on-site three days/week in Redwood City, CA.

Requirements

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

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 document
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