Apply on Employer Site

Corcept Therapeutics · 1 month ago

Senior Director, Patient Safety & PV Science

Redwood City, California, United States

Full-time

Hybrid

Director/Executive

$298K/yr - $315K/yr

8+ years exp

Corcept is a leader in the research and development of cortisol modulators, focusing on innovative treatments for serious diseases. The Senior Director of Patient Safety & PV Science will oversee safety monitoring and governance for Corcept products, collaborating cross-functionally to execute corporate development strategies and ensure compliance with safety regulations.

BiotechnologyMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

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

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

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

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

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

Serve as a subject matter expert (SME) for relevant PSPV Science processes

Qualification

Patient SafetyPharmacovigilanceSignal DetectionRisk ManagementData AnalysisArgusRegulatory KnowledgeTeam LeadershipCommunication SkillsCollaboration Skills

Required

Safety monitoring of assigned Corcept products (investigational and marketed)

Core safety deliverables related to safety governance, signal detection/management, and periodic and aggregate reporting

High level of strategic thinking

Collaboration with PSPV team members to manage key safety surveillance activities, safety analyses, risk management and safety document deliverables

Engagement and collaboration cross-functionally to execute on the corporate development strategy

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

Collaboration with safety physicians on signal detection and risk management activities

Review of medical and scientific literature to support signal detection and aggregate 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

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

Lead/contribute to health authority or other safety related query responses for Corcept products

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

Serve as a subject matter expert (SME) for relevant PSPV Science processes

Preferred

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