Senior Medical Director, Global Risk Management & Safety Surveillance

Incyte is seeking a Senior Medical Director to lead global risk management and safety surveillance for molecular entities and marketed products in Morges, CH.

This position directs all patient safety risk management activities for Incyte's investigational and marketed medicinal products. The role focuses on pharmacovigilance efforts to identify, characterize, and minimize risks throughout the product lifecycle.

Responsibilities

• Direct the Safety Management Team and supervise all safety risk management tasks for designated products.
• Oversee the creation and implementation of local and global risk management plans across the entire product lifecycle.
• Develop clinical trial and post-marketing safety strategies aligned with the company's drug development and commercialization goals.
• Conduct drug safety signal detection activities for the portfolio of investigational and marketed products.
• Monitor and evaluate benefit-risk profiles to maintain a favorable balance.
• Medically review Individual Case Safety Reports (ICSRs) and guide the Case Operations team to ensure high-quality reporting.
• Analyze emerging literature on Incyte products and collaboration partner products to identify new safety information.
• Lead the preparation of IND Annual Reports and/or DSURs for clinical programs, and PADERs and/or PSUR/PBRERs for marketed products.
• Perform Health Hazard Evaluations.
• Play a key role in developing integrated summaries of safety, clinical overviews, and registration documents for new and supplemental NDAs.
• Establish safety strategies for Reference Safety Information, including Investigator Brochures and labeling updates (USPI, SmPC, CDS).
• Participate in internal safety process improvements, including new ways to present early-phase clinical study safety findings.
• Support regulatory authority inspections and internal pharmacovigilance audits.
• Review and revise standard response letters and communications containing adverse event information, collaborating with Medical Affairs.
• Champion risk management safety strategies to internal and external stakeholders.
• Act as the GRMSS medical representative for joint clinical development programs with external partners.
• Respond to product-related queries on behalf of the EU/UK QPPV when needed.

Requirements

• Hold an M.D. or equivalent international medical qualification.
• Possess several years of experience in the pharmaceutical/biotechnology industry or a regulatory agency, with significant pharmacovigilance or risk management expertise.
• Demonstrate in-depth knowledge of the global risk management/GVP landscape, particularly in the US and EU regions.
• Show experience interacting with regulators on risk management issues.
• Have experience contributing to drug registrations, including Clinical Study Reports, Integrated Summaries of Safety, and Clinical Overviews.

Nice to have

• Relevant experience in epidemiology, such as an M.P.H. or equivalent industry/academic experience.
• Board certification in internal medicine, pediatrics (primary care), or hematology/oncology (specialty).
• Experience in pharmaceutical industry activities, including international exposure.
• Experience in clinical trial development and execution.
• Experience in oncologic or inflammatory diseases, or in clinical safety support of oncology, immunomodulatory, or related products.

About the company

Incyte welcomes candidates with diverse backgrounds and experiences, fostering an inclusive environment.

• The company values diversity in backgrounds and experiences.