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 Role

 

As Director, Global Drug Safety & Pharmacovigilance Physician, you will provide medical leadership and strategic oversight of safety for assigned Genmab oncology assets across the product lifecycle, with a strong focus on early phase clinical development. Reporting into the Medical Safety organization, you will play a critical role in protecting patient safety while enabling the development of innovative therapies.

You will lead the medical assessment of safety data, drive benefit-risk evaluations, oversee signal detection and risk management activities, and provide expert medical guidance across multidisciplinary development teams. Working closely with colleagues across Clinical Development, Drug Safety & Pharmacovigilance, Regulatory Affairs, Clinical Operations, Biostatistics, Medical Writing, Translational Research, Quality, and external partners, you will ensure scientifically sound and compliant safety decisions throughout development.

 

In this role, you will join the small team in our Netherlands office where you will serve as a trusted medical safety leader who brings people together, facilitates open dialogue, and provides clear guidance in complex situations. Success in this role requires someone who enjoys collaborating across functions, communicates proactively, and builds strong relationships with both internal and external stakeholders. You combine scientific expertise with a pragmatic, down-to-earth approach and know how to balance independent decision-making with timely communication and stakeholder engagement.

 

Responsibilities

 

Provide strategic medical safety leadership

• 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.

Lead safety surveillance and medical review

• 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.

Drive regulatory and clinical safety deliverables

• 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.

Lead governance and cross-functional collaboration

• 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.

Strengthen quality and continuous improvement

• 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.

 

Requirements

 

To succeed in this role, you are an experienced physician with deep expertise in medical safety and pharmacovigilance, combined with the ability to influence, collaborate, and provide strategic leadership across a complex global organization.

You bring:

• 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.

The proposed gross annual base salary range for this position, in the primary location, based on a full time schedule is:

EUR95.472,00---143.208,00

The final salary offer will depend on several factors, including your skills, qualifications, and experience.

In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to:

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

Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the contract.