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

Location: Wilmington, Delaware, United States, or Morges, Switzerland

Company

hirify.global is a global biopharmaceutical company developing and commercializing medicines in hematology, oncology, inflammation, and autoimmunity.

What you will do

• Lead Safety Management Teams and direct global and local risk-management activities for investigational and marketed products.
• Develop clinical-trial and postmarketing safety strategies aligned with drug development and commercialization plans.
• Detect and evaluate safety signals, conduct health-hazard evaluations, and make actionable recommendations.
• Manage benefit-risk evaluations and oversee preparation of IND Annual Reports, DSURs, PADERs, PSURs, and PBRERs.
• Contribute to integrated safety summaries, clinical overviews, regulatory submissions, investigator brochures, and product labeling.
• Lead cross-functional collaboration with Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, Legal, commercial collaborators, regulators, and joint-development partners.

Requirements

• M.D. or international equivalent.
• At least 10 years of pharmaceutical, biotechnology, or regulatory-agency experience, including more than 5–10 years in pharmacovigilance or risk management.
• In-depth knowledge of the US and EU risk-management and GVP landscape.
• Direct experience interacting with regulators on risk-management issues.
• Experience contributing to drug registrations, including Clinical Study Reports, Integrated Summaries of Safety, Summaries of Clinical Safety, and Clinical Overviews.
• Strong people-management, team leadership, collaboration, and cross-functional communication skills.

Nice to have

• M.P.H. or relevant epidemiology experience.
• Board certification in internal medicine, pediatrics, hematology, or oncology.
• Experience with pharmaceutical activities outside the United States and with clinical-trial development and execution.
• Training or experience in oncology, inflammatory diseases, immunomodulatory products, or related clinical-safety support.

Culture & Benefits

• Work with internal teams and external partners on global patient-safety strategies.
• Participate in pharmacovigilance process improvements, inspection readiness, audits, and corrective or preventive action planning.
• Support safety communications and responses concerning adverse-event information.
• Collaborate across North American, European, and Asian operations.