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

Overview

A global biopharmaceutical company on a mission to solve oncology, 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 as for Incyte marketed products. This includes 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 requires strong oversight for patient safety issues that arise at both the individual and aggregate levels, strong decision‑making skills on all safety assessment and surveillance issues, responsibility for compliant, timely, and complete regulatory authority engagement, and effective communication of safety information to internal and external stakeholders. The role leads teams and engages cross‑functionally and reports to the Head of Global Pharmacovigilance and Risk Management.

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 post‑marketing risk management safety strategies that align with the company’s drug development and commercialization strategies.
• Perform drug safety signal detection activities; 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 a favorable balance.
• Provide secondary medical review of individual case safety reports (ICSRs) for designated products as necessary, and provide follow‑up guidance for specific safety topics to the Case Operations team or PhV vendor to ensure consistent high‑quality reports.
• Review emerging literature regarding Incyte products and relevant products from collaboration partners to identify new and important information that potentially impacts 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 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.
• Participate in internal safety process improvements and updates, including new 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 develop and implement corrective action plans for identified deficiencies of policy, procedure, or practice 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 backup) 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 in a pharmacovigilance or risk management role.
• In‑depth knowledge of US/EU risk management/GVP landscape.
• First‑hand experience interacting with regulators on 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.