Associate Director, Global Drug Safety & Pharmacovigilance Physician, Oncology; Early Phase Cli

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.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Associate Director, Safety Physician, who reports to early phase medical safety team lead, provides medical leadership and oversight of safety strategy and execution for assigned Genmab oncology assets across the product lifecycle, with a strong emphasis on early phase clinical trials. The role is accountable for proactive safety surveillance, signal management, benefit–risk evaluation, and risk mitigation activities, in close partnership with Drug Safety & Pharmacovigilance internal team and cross‑functional stakeholders (Medical, Clinical Development, Clinical Operations, Regulatory, Biostatistics, Non‑clinical safety, Clinical pharmacology, Translational, Medical Writing, Quality, and external vendors/partners).

The Associate Director ensures subject safety and welfare while driving compliant, scientifically rigorous safety decision‑making, implementation and communications.

• Medical safety leadership and accountability: Lead and oversee major safety‑related activities for assigned products, including safety surveillance, signal detection, benefit–risk evaluation, and risk management throughout the product lifecycle.
• Cross‑functional safety governance: Chair and manage Genmab Safety Committees, ensure appropriate charters, effective meeting management, and timely documentation of decisions.
• Risk mitigation: In collaboration with Medical team, handle safety issues, propose risk mitigation strategies, and ensure effective implementation.
• Stakeholder engagement and influence: Proactively engage internal multidisciplinary teams and serve as a medical safety interface with external experts, partners, CROs, and Regulatory Authorities as needed.
• Continuous processes improvement: Provide feedback and propose systemic solutions to strengthen safety processes, quality, and compliance.

Safety assessment and surveillance

• Perform and/or oversee medical review and assessment of adverse event data and individual case safety reports from multiple sources, including clinical trials and post‑marketing activities.
• Conduct ongoing surveillance of safety data and scientific literature; evaluate emerging signals and relevant external landscape information.
• Assess urgent safety issues, provide risk categorization and mitigation strategy, ensure timely communication with the health authorities and investigators.

Safety documentation and regulatory deliverables

• Prepare and/or provide medical oversight for regulatory‑compliant safety documentation, including aggregate reports, safety summaries, risk management documents (e.g., DSURs, benefit–risk sections, integrated safety summaries, periodic/aggregate benefit–risk content, dRMP/RMP).
• Provide medical safety input to core clinical and operational documents based on review (e.g., trial protocols, amendments and plans; clinical trial reports; Investigator’s Brochure; subject informed consent; eCRFs/CRFs; TMF‑related safety documentation).
• Contribute medical review and input to relevant scientific articles and medical reviews, as required.

Safety communication

• Communicate changes in the product risk profile internally and externally, ensuring clarity, scientific grounding, and alignment with regulatory expectations…