Associate Director, Global Drug Safety & Pharmacovigilance Physician, Oncology (Early Phase Clinical Development)

Associate Director, Global Drug Safety & Pharmacovigilance Physician, Oncology (Early Phase Clinical Development)

Genmab

Utrecht or Copenhagen

Role

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.

Key Leadership Responsibilities

• 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.

Core Responsibilities

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 and cross-functional strategy.

Sponsor oversight and vendor collaboration

• Provide sponsor oversight of safety and clinical CROs/vendors; ensure delivery quality, compliance, and appropriate issue escalation/resolution;
• Collaborate effectively with Drug Safety and cross-functional teams to ensure robust safety assessment, ongoing surveillance, and clear, timely safety communications.

Audit and inspection readiness

• Ensure compliance with global pharmacovigilance regulations, internal procedures, and quality standards, maintaining continuous inspection readiness;
• Actively participate in PV audits and Regulatory Authority inspections, including inspection preparation, direct interactions, and response/CAPA contributions as relevant;
• Provide guidance, develop and deliver training for internal and external stakeholders (e.g., Genmab employees, CROs, investigators) on emerging safety topics, PV processes, technologies, and evolving global requirements.

Requirements

• MD (or equivalent medical degree) required;
• 5+ years of experience in drug safety/pharmacovigilance across clinical development and post-marketing, preferably in oncology;
• Demonstrated experience leading medical safety activities for early phase clinical trials (Phase 1/2), including complex safety decision-making and cross-functional governance;
• Proven ability to guide and mentor team members, strong matrix leadership and stakeholder management skills;
• Experience with PV audit processes, including active participation in Regulatory Authority inspections, and working with FDA, EMA and other health authorities;
• Strong understanding of the global PV regulatory environment (regulations, initiatives, standards, GVP) and working knowledge of MedDRA and WHODrug;
• Experience overseeing individual case processing activities, including medical review, and contributing to signal evaluation;
• Experience with safety databases (e.g., Argus, or comparable systems) and clinical database;
• Excellent written and verbal communication skills, including authoring/reviewing safety sections of clinical/regulatory documents and presenting to internal and external governance bodies;
• Experience contributing to managing urgent safety issues and oncology protocol development.

About You

• You are genuinely passionate about our purpose;
• You bring precision and excellence to all that you do;
• You believe in our rooted-in-science approach to problem-solving;
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds;
• You take pride in enabling the best work of others on the team;
• You can grapple with the unknown and be innovative;
• You have experience working in a fast-growing, dynamic company (or a strong desire to);
• You work hard and are not afraid to have a little fun while you do so!