Safety Science Director

The Safety Science Director will report to the Head of Safety Science and is responsible and is responsible for safety monitoring of assigned Corcept products (investigational and marketed), with core safety deliverables related to safety governance, signal detection/management, periodic and aggregate reporting, and executing on the corporate development strategy.

Responsibilities:

• Perform safety analyses through appropriate data selection, review of case series, data summaries and/or AE trend information, including data from clinical trials and post marketing
• Conduct review of medical and scientific literature for signal detection and aggregate reporting activities
• Lead the preparation and development of safety reports/ deliverables, including Integrated Summaries of Safety (ISS)
• Work closely with safety physicians and liaise with cross-functional stakeholders and teams on signal detection and risk management activities
• Mentor, train and collaborate with junior scientists on signal detection and risk management activities
• Lead the development and maintenance of Risk Management Plans (RMPs)/Risk Evaluation and Mitigation Strategies (REMS) for assigned product(s). As required, develop a product-specific Safety Plan. Perform safety data monitoring, analysis, and interpretation. Maintain good documentation. Communicate safety profile effectively (written and verbal) both internally and externally
• Prepare and review aggregate safety reports for assigned product(s)
• Provide safety input to statistical analysis plans and data analysis visualizations, and similar documents requiring significant safety analysis. Ensure consistent presentation of safety and risk management topics across various regulatory documents. Contribute to and/or review safety sections of clinical documents, including Investigator’s brochure (IB), clinical study protocols, clinical study reports
• Work closely with safety physicians and liaise with cross-functional stakeholders in authoring the safety sections of a regulatory package (e.g., NDA, Briefing Document). Lead in the creation of health authority or other safety related query responses for assigned product(s)
• Participate in safety governance meetings and support safety deliverables related to cross functional or benefit-risk assessment meetings, including creation and maintenance of product core safety information and company core data sheets (CCDSs)
• Support PV vendor oversight, continuous process improvement, and inspections and audits
• Provide scientific and technical leadership to support discovery and development project teams
• Maintain up to date knowledge related to technical area of expertise including areas of disease, drugs, data interpretation and integration, and regulatory and business environment

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
• Knowledge of ICH guidelines and GVP
• 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
• 6+ years in experience in patient safety and pharmacovigilance in the capacity of a scientist with a focus in post-approval setting; at least 2 years of clinical development experience is required
• Authoring and review of periodic and ad hoc safety reports (more than 3 years of experience required in safety or clinical documents such as PSURs, DSURs, Clinical Overviews, Clinical Study Reports or summaries)
• Experience in writing safety analyses, performing signal detection or safety surveillance, risk management and preparing responses to HA
• Experience with NDA/MAA filing

The pay range that the Company reasonably expects to pay for this headquarters-based position is $243,300 - $286,300; 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.