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

A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity. The Senior Medical Director - Executive Medical Director, Global Risk Management & Safety Surveillance (GRMSS), is responsible for developing and ensuring execution of all patient safety risk management activities for molecular entities under clinical development as well for Incyte marketed products. The Executive Medical Director reports to the Head of Global Pharmacovigilance and Risk Management.

Responsibilities

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); Review emerging literature regarding Incyte products, as well as relevant products from collaboration partners, to identify new and important information that potentially impact human safety; Drive preparation of IND Annual Reports and/or DSURs for Incyte clinical trial programs, and PADERs and/or PSUR/PBRERs for marketed products; Perform Health Hazard Evaluations; Participate significantly in the strategic planning, development, and production of integrated summaries of safety, summaries of clinical safety, clinical overviews, and other registration documents for new and supplemental NDAs/BLAs and/or ex-US new drug submissions/variations; 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; Participate in internal safety process improvements and updates; Contribute to preparedness for regulatory authority inspection and internal audits of Pharmacovigilance, and contribute to the development and implementation of preventative and/or corrective action plans in GRMSS; Review medical and safety content included in standard response letters prepared by Medical Affairs, and work with Medical Affairs to create and periodically revise standard communications that include specific adverse event information; Champion risk management safety strategy to internal and external stakeholders; 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

Requirements

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

Nice to have

M.P.H. or relevant epidemiology experience in industry or academia; Board certification in internal medicine or pediatrics (primary care), or hematology/oncology (specialty); Experience in pharmaceutical industry activities outside the United States; Experience in clinical trial development and execution; Training or experience in oncologic or inflammatory diseases, or relating to clinical safety support of oncology, immunomodulatory, or other related products