Associate Director, Companion Diagnostics

Overview At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking medicines that change lives and the future of cancer treatment and serious diseases. We strive to create 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. Does this inspire you and feel like a fit? Then we would love to have you join us! The Role Genmab is seeking an Associate Director, Clinical Biomarkers & Companion Diagnostics to lead biomarker and companion diagnostic (CDx) strategies across our oncology portfolio, including antibody-drug conjugates, bispecific antibodies, and immune-modulating therapies. This role partners cross-functionally with Clinical Development, Translational Research/Medicine, Pathology, Genomics, Regulatory Affairs, Biomarker Operations, and external diagnostic collaborators to ensure biomarkers and CDx are effectively integrated into clinical trials. You will be part of the Diagnostics team within Translational & Quantitative Sciences and operate in a highly matrixed, cross-functional environment to advance precision medicine strategies aligned with program and portfolio goals. Key Responsibilities Lead CDx strategy for oncology programs from early development through late-stage clinical trials and global Health Authority approvals. Represent Diagnostics on compound development teams, providing strategic guidance and coordinating stakeholder alignment for programs requiring predictive biomarkers. Develop and execute integrated CDx plans to support patient selection, stratification, therapy assessment, and commercial viability of the CDx assay. Ensure CDx timelines and deliverables are synchronized with clinical development milestones, regulatory submissions, and commercialization planning. Select and manage CROs and IVD companies through prototype assay development, feasibility studies, analytical/clinical validation, and global regulatory submissions. Contribute biomarker content to protocols, lab manuals, IBs, ICFs, SRDs, IDEs, CSRs, IND/CTA submissions, briefing documents, and regulatory responses. Interpret biomarker and CDx data to inform patient enrichment strategies and advise on key go/no-go decisions. Present CDx strategy and results to senior leadership, governance committees, and external stakeholders. Stay current on emerging IVD technologies and fit-for-purpose assay development. Support publications, congress abstracts, and regulatory briefing documents. Qualifications and Experience PhD in a biological science with at least 7 years of industry experience integrating biomarker assays into clinical trials. Additional educational profiles will be considered for exceptional candidates with CDx development experience in both IVD companies and biotech/pharma. Experience in oncology and immuno-oncology drug development with demonstrated success driving biomarker-driven patient selection strategies in hematologic malignancies and/or solid tumors. Working knowledge of CDx development processes including analytical/clinical validation strategies, design control, and global regulatory interactions related to CDx submissions. Scientific expertise in established and novel CDx assay technologies (e.g. IHC, NGS, PCR, flow cytometry, liquid biopsy, MRD testing and digital pathology). Experience authoring biomarker sections in clinical protocols, informed consent forms, Health Authority briefing documents and regulatory documentation. Demonstrated ability to lead cross-functional teams and manage external vendors. Strong oral and written communication skills. For US based candidates, the proposed salary band for this position is as follows: $151,680.00---$227,520.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses 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! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. 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 fixed-term employment contract. #J-18808-Ljbffr