Associate Director, Companion Diagnostics

At Genmab we are dedicated to building extranotordinary 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:

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:

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 youre 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 youre 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 Genmabs 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 and follow us on LinkedIn and X.

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Please note that if you are applying for a position in the Netherlands Genmabs 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.