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

Role: Senior/Executive Medical Director in Global Risk Management & Safety Surveillance, overseeing patient safety activities for Incyte's clinical and marketed products. Responsibilities: lead safety risk management strategies, perform signal detection, benefit-risk assessments, and ensure regulatory compliance across global safety plans; provide medical review of individual case safety reports (ICSRs); contribute to safety documentation like IND annual reports, DSURs, and regulatory submissions; participate in safety strategy development for reference safety information and labeling; lead cross-functional teams, manage safety communications, and serve as the medical representative in collaborative programs. Requirements: MD or equivalent; 10+ years pharma/biotech experience with 5-10+ years in pharmacovigilance or risk management; deep knowledge of US/EU GVP regulations; experience with regulatory interactions and drug registration safety documentation; strong leadership and cross-functional collaboration skills. Preferred: MPH or epidemiology background; board certification (internal medicine, pediatrics, hematology/oncology); international industry experience; familiarity with clinical trial safety support in oncology or immunomodulatory areas. HighValue: extensive pharmacovigilance expertise, global safety strategy, regulatory engagement, clinical safety in oncology/inflammation, leadership in safety teams. WorkSetup: not specified, likely office-based with international stakeholder engagement.