Associate Director, Companion Diagnostics
The Antibody Society, Princeton, NJ, United States
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
o‑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 (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.
Salary (U.S. based candidates)
$151,680.00 – $227,520.00. The actual salary offer will consider skills, qualifications, experience, and location. Certain positions may also be eligible for discretionary bonuses and long‑term incentives.
Benefits
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 are in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.
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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
o‑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 (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.
Salary (U.S. based candidates)
$151,680.00 – $227,520.00. The actual salary offer will consider skills, qualifications, experience, and location. Certain positions may also be eligible for discretionary bonuses and long‑term incentives.
Benefits
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 are in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.
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