Senior Medical Director - Executive Medical Director, Global Risk Management & Safety Surveillance

Essential Functions Of The Job

• Lead the Safety Management Team and direct all safety risk management activities for assigned products.
• Lead other teams, as required.
• Ensure local and global risk management plan preparation and execution throughout a medicinal product’s lifecycle.
• Formulate clinical trial and postmarketing risk management safety strategies that are in alignment with the company's drug development and commercialization strategies.
• Perform drug safety signal detection activities for Incyte’s portfolio of investigational and marketed products; develop medically reasonable evaluations of safety signals; and make specific, actionable, and defensible recommendations for confirmation or refutation of safety signals.
• Manage and monitor benefit-risk evaluations to ensure favorable benefit-risk balance.
• Provide secondary medical review of ICSRs for designated products as necessary as well as back-up when primary medical reviewer is not available, and provide follow-up guidance for specific safety topics to Case Operations team (or PhV vendor as appropriate) to ensure consistent high-quality reports.
• Drive the safety strategy for Reference Safety Information for Incyte products, including Investigator Brochures and new or updated labeling (USPI, SmPC or CDS) for marketed products in the context of multidisciplinary groups within Incyte or joint committees between external partners.
• Participate in internal safety process improvements and updates, including new means of effective presentation of early phase clinical study status reports with regard to safety findings.
• Contribute to preparedness for regulatory authority inspection and internal audits of Pharmacovigilance, and contribute to the development and implementation of any preventative and/or corrective action plans as they pertain to specific identified deficiencies of policy, procedure, or practice in GRMSS.
• Review medical and safety content included in standard response letters prepared by Medical Affairs, as necessary, and work with Medical Affairs to create and periodically revise standard communications that include specific adverse event information.
• Serve as the GRMSS medical representative for joint clinical development programs with external partners as required.
• In the absence of the EU/UK QPPV, the GRMSS physician (or their back-up) is responsible for responding to product-related queries as delegated by the EU/UK QPPV.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• M.D. or international equivalent.
• Minimum of 10 years total pharmaceutical/biotechnology industry or regulatory agency experience, of which more than 5-10 years will have been in a pharmacovigilance or risk management role.
• In-depth knowledge of US/EU risk management/GVP landscape.
• First-hand experience interacting with regulators with risk management issues.
• Experience as an active contributor with drug registrations (Clinical Study Reports, Integrated Summaries of Safety, Summaries of Clinical Safety, and Clinical Overviews).
• Strong interpersonal and people management skills; experience effectively leading teams.
• Strong collaboration skills and ability to engage cross functionally.

Disclaimer

The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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