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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.

Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.

Job Summary

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. This will include pharmacovigilance and risk management activities and interventions designed to identify, characterize, prevent or minimize risks relating to medicinal products, including the assessment of the effectiveness of those activities and interventions. The position will require strong oversight for patient safety issues that arise at both the individual and aggregate levels (within the company and in collaboration with co-development and business partners); strong decision-making skills on all issues involving safety assessment and surveillance; responsibility for compliant, timely, and complete regulatory authority engagement (with particular emphasis on benefit-risk assessments and risk identification/characterization and mitigation/management); and effective communication of safety information to internal and external stakeholders. The position will need to effectively lead teams and engage cross-functionally. The Executive Medical Director reports to the Head of Global Pharmacovigilance and Risk Management.

Essential Functions of the Role

• 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
• 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; conduct reviews both independently within Incyte and in conjunction with external collaboration partners.
• 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 for late-phase drug development candidates and marketed products in conjunction with Clinical Development, Medical Writing, Statistics, and Regulatory Affairs.
• 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.
• Champion risk management safety strategy to internal (eg, Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Translational & Experimental Medicine and Legal) and external (eg, regulators and commercial collaborators) 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.

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.
• Preferable (but not an absolute requirement):
• 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.

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.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.