Director, Global Drug Safety & Pharmacovigilance Physician

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

• Lead medical safety strategy and oversight for assigned products throughout the product lifecycle, with particular emphasis on early phase clinical trials.
• Ensure the safety and welfare of subjects participating in Genmab clinical studies through proactive medical safety leadership.
• Lead benefit-risk evaluations, signal detection, risk management activities, and safety governance for assigned development programs.
• Drive the medical assessment of emerging safety issues and recommend appropriate mitigation strategies.

• Oversee ongoing surveillance of safety information from clinical trials, post-marketing data, scientific literature, and other relevant sources.
• Perform and oversee medical review of individual adverse event reports and safety cases from multiple sources.
• Evaluate emerging safety signals and communicate changes to the product safety profile internally and externally, as appropriate.
• Assess urgent safety issues, prepare Health Hazard Assessments where required, and contribute to product recalls and other critical safety activities.

• Provide medical oversight and strategic input into regulatory safety documents, including Development Safety Update Reports (DSURs), integrated safety summaries, benefit-risk assessments, risk management plans, and other aggregate safety reports.
• Review and provide medical input to clinical development documents, including protocols, protocol amendments, Investigator's Brochures, informed consent forms, clinical study reports, eCRFs/CRFs, TMF documentation, and scientific publications.
• Ensure regulatory compliance and scientific quality across all safety deliverables.

• Chair and manage Genmab Safety Committees and oversee external Data Monitoring Committees (DMCs), ensuring effective governance and timely decision-making.
• Represent Medical Safety within Clinical Development Teams and multidisciplinary project teams.
• Act as the medical safety representative with Regulatory Authorities, CROs, external experts, and collaboration partners.
• Provide sponsor oversight of safety-related vendor activities, ensuring quality, compliance, and effective issue resolution.

• Ensure compliance with global pharmacovigilance regulations, internal procedures, and quality standards while maintaining inspection readiness.
• Participate in audits and regulatory inspections and contribute to inspection responses and continuous process improvements.
• Mentor colleagues and provide training to Genmab employees, investigators, and external partners on medical safety topics and pharmacovigilance processes.

• A MD (or equivalent medical degree).
• Extensive experience, a minimum of 8 years, in drug safety and pharmacovigilance within the biotechnology or pharmaceutical industry, including both clinical development and post-marketing activities.
• Demonstrated leadership of medical safety activities for early phase oncology clinical trials, including complex safety assessments, signal detection, benefit-risk evaluation, and risk management.
• Experience providing strategic medical input to regulatory submissions and safety documentation, including aggregate reports, risk management plans, and clinical development documents.
• Strong understanding of global pharmacovigilance regulations, GVP, MedDRA, WHODrug, and interactions with Health Authorities such as the FDA and EMA.
• Experience chairing or contributing to safety governance committees and working effectively within multidisciplinary development teams.
• Experience overseeing safety vendors and CROs while ensuring appropriate sponsor oversight and regulatory compliance.
• Experience participating in pharmacovigilance audits and regulatory inspections.
• Excellent communication and stakeholder management skills, with the ability to translate complex safety information into clear recommendations for diverse audiences.
• A collaborative and approachable leadership style. You enjoy working with colleagues across functions, foster open communication, and know when to engage stakeholders to enable effective decision-making.
• A pragmatic, down-to-earth mindset with the confidence to make sound medical judgments while remaining open to different perspectives.
• Fluency in written and spoken English, as it's Genmab's primary language.

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs