Director, Companion Diagnostic Program Manager
Genmab
June 24, 2026
Remote friendly (Princeton, NJ)
United States
Clinical Research and Development
Director, Companion Diagnostic Program Manager
Key Responsibilities:
- Provide strategic and operational leadership for planning, development, validation, and execution of companion diagnostic (CDx) assays 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 using predictive biomarkers.
- Lead integrated CDx planning to support patient selection, therapeutic assessment, regulatory approval, and commercial viability.
- Align CDx timelines and deliverables with clinical milestones, regulatory submissions, and commercialization plans.
- Present CDx strategy, progress, and results to senior leadership, governance committees, and external stakeholders.
- Prepare materials for governance decisions, including diagnostic strategy, execution, and vendor selection.
- Oversee external diagnostic partnerships (scope, performance, risk, issues, budget accountability, Joint Steering Committee support).
- Partner with CDTL/compound PM, Clinical Strategy, Precision Medicine, Regulatory Affairs, and Quality to meet protocol, regulatory, and operational needs.
- Support inspection readiness and participate in internal/external audits.
Requirements:
- Bachelor’s degree in Biological Sciences, Bioengineering, or related field; 10+ years in diagnostics/pharmaceuticals/life sciences.
- 7+ years in project management/portfolio strategy or related leadership roles.
- Oncology/immuno-oncology experience; success driving biomarker-based patient selection in hematologic malignancies and/or solid tumors.
- Knowledge of CDx development: analytical/clinical validation, design controls, and global regulatory interactions.
- Ability to lead cross-functional teams and manage external vendors/partners.
- Experience managing program budgets and vendor contracts.
- Proficiency with Microsoft Project and/or Planisware.
- US-based; remote or hybrid from Princeton, NJ or Boston, MA.
Benefits (within first year for regular full-time U.S. employees): 401(k) match, medical/dental/vision, voluntary insurance, paid time off including 12 weeks discretionary parental leave, backup care and wellness resources, commuter benefits, tuition reimbursement, Lifestyle Spending Account.
Key Responsibilities:
- Provide strategic and operational leadership for planning, development, validation, and execution of companion diagnostic (CDx) assays 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 using predictive biomarkers.
- Lead integrated CDx planning to support patient selection, therapeutic assessment, regulatory approval, and commercial viability.
- Align CDx timelines and deliverables with clinical milestones, regulatory submissions, and commercialization plans.
- Present CDx strategy, progress, and results to senior leadership, governance committees, and external stakeholders.
- Prepare materials for governance decisions, including diagnostic strategy, execution, and vendor selection.
- Oversee external diagnostic partnerships (scope, performance, risk, issues, budget accountability, Joint Steering Committee support).
- Partner with CDTL/compound PM, Clinical Strategy, Precision Medicine, Regulatory Affairs, and Quality to meet protocol, regulatory, and operational needs.
- Support inspection readiness and participate in internal/external audits.
Requirements:
- Bachelor’s degree in Biological Sciences, Bioengineering, or related field; 10+ years in diagnostics/pharmaceuticals/life sciences.
- 7+ years in project management/portfolio strategy or related leadership roles.
- Oncology/immuno-oncology experience; success driving biomarker-based patient selection in hematologic malignancies and/or solid tumors.
- Knowledge of CDx development: analytical/clinical validation, design controls, and global regulatory interactions.
- Ability to lead cross-functional teams and manage external vendors/partners.
- Experience managing program budgets and vendor contracts.
- Proficiency with Microsoft Project and/or Planisware.
- US-based; remote or hybrid from Princeton, NJ or Boston, MA.
Benefits (within first year for regular full-time U.S. employees): 401(k) match, medical/dental/vision, voluntary insurance, paid time off including 12 weeks discretionary parental leave, backup care and wellness resources, commuter benefits, tuition reimbursement, Lifestyle Spending Account.