Director, Companion Diagnostic Program Manager
Genmab
August 06, 2026
Remote friendly (Princeton, NJ)
United States
Clinical Research and Development
Director, Companion Diagnostic Program Manager
Responsibilities:
- Provide strategic and operational leadership for planning, development, validation, and execution of companion diagnostic (CDx) assay projects across the oncology portfolio.
- Lead CDx sub-teams with CDx SMEs to integrate CDx strategy into the Compound Development Plan and Target Product Profile.
- Drive cross-functional alignment for programs requiring predictive biomarkers.
- Lead development and execution of integrated CDx plans supporting patient selection, therapeutic assessment, regulatory approval, and commercial viability.
- Ensure CDx timelines and deliverables align with clinical milestones, regulatory submissions, and commercialization plans.
- Present CDx strategy, progress, and results to senior leadership, governance committees, and external stakeholders.
- Prepare governance committee presentations to support diagnostic strategy, execution, and vendor selection decisions.
- Oversee external diagnostic partnerships (scope, performance oversight, risk/issues, budgeting, and Joint Steering Committee activities).
- Partner with CDTL/compound PM, Clinical Strategy, Precision Medicine, Regulatory Affairs, and Quality to meet protocol, regulatory, and operational requirements.
- Support inspection readiness and participate in internal/external audits.
Requirements / Qualifications:
- Bachelor’s degree in Biological Sciences, Bioengineering, or related field; 10+ years in diagnostics, pharmaceuticals, or life sciences.
- 7+ years in project management, portfolio strategy, or related leadership.
- Oncology/immuno-oncology experience; success leading biomarker-based patient selection in hematologic malignancies and/or solid tumors.
- Knowledge of CDx development (analytical/clinical validation, design controls, global regulatory interactions).
- Ability to lead cross-functional teams and manage vendors/partners.
- Experience managing complex budgets and external vendor contracts (forecasting, financial planning, resource allocation).
- Advanced proficiency with Microsoft Project and/or Planisware.
- US-based; 60% hybrid from Princeton, NJ office.
Benefits:
- 401(k) 100% match on first 6% of contributions; two medical options (incl. HDHP with HSA), dental, vision; critical illness/accident/hospital indemnity; paid vacation/sick leave/holidays; 12 weeks discretionary paid parental leave; child/adult backup care and family support; commuter benefits, tuition reimbursement, Lifestyle Spending Account.
Application instructions:
- None stated.
Responsibilities:
- Provide strategic and operational leadership for planning, development, validation, and execution of companion diagnostic (CDx) assay projects across the oncology portfolio.
- Lead CDx sub-teams with CDx SMEs to integrate CDx strategy into the Compound Development Plan and Target Product Profile.
- Drive cross-functional alignment for programs requiring predictive biomarkers.
- Lead development and execution of integrated CDx plans supporting patient selection, therapeutic assessment, regulatory approval, and commercial viability.
- Ensure CDx timelines and deliverables align with clinical milestones, regulatory submissions, and commercialization plans.
- Present CDx strategy, progress, and results to senior leadership, governance committees, and external stakeholders.
- Prepare governance committee presentations to support diagnostic strategy, execution, and vendor selection decisions.
- Oversee external diagnostic partnerships (scope, performance oversight, risk/issues, budgeting, and Joint Steering Committee activities).
- Partner with CDTL/compound PM, Clinical Strategy, Precision Medicine, Regulatory Affairs, and Quality to meet protocol, regulatory, and operational requirements.
- Support inspection readiness and participate in internal/external audits.
Requirements / Qualifications:
- Bachelor’s degree in Biological Sciences, Bioengineering, or related field; 10+ years in diagnostics, pharmaceuticals, or life sciences.
- 7+ years in project management, portfolio strategy, or related leadership.
- Oncology/immuno-oncology experience; success leading biomarker-based patient selection in hematologic malignancies and/or solid tumors.
- Knowledge of CDx development (analytical/clinical validation, design controls, global regulatory interactions).
- Ability to lead cross-functional teams and manage vendors/partners.
- Experience managing complex budgets and external vendor contracts (forecasting, financial planning, resource allocation).
- Advanced proficiency with Microsoft Project and/or Planisware.
- US-based; 60% hybrid from Princeton, NJ office.
Benefits:
- 401(k) 100% match on first 6% of contributions; two medical options (incl. HDHP with HSA), dental, vision; critical illness/accident/hospital indemnity; paid vacation/sick leave/holidays; 12 weeks discretionary paid parental leave; child/adult backup care and family support; commuter benefits, tuition reimbursement, Lifestyle Spending Account.
Application instructions:
- None stated.