The Role & Department

As a Director, Companion Diagnostic Program Manager, you will be part of the Program Management function and will be responsible for providing strategic and operational leadership for the planning, development, validation, and execution of companion diagnostic assays (CDx) projects across our oncology portfolio.

The role leads CDx sub-teams, in partnership with CDx SMEs to ensure that the CDx strategy (where applicable) is effectively integrated into Compound Development Plan and Target Product Profile. This position is responsible for delivering compliant, high-quality diagnostic solutions aligned with clinical development timelines and regulatory expectations.

You will report to the Head of Program Management and work closely with colleagues from Translational & Quantitative Sciences (including the Companion Diagnostic expert team), Clinical Strategy, Regulatory, Commercial, Market Access and external diagnostic collaborators.

Key responsibilities include:
• Lead development of CDx strategy for oncology programs from early through late-stage development and global Health Authority approvals in partnership with CDx SMEs, who will represent the CDx sub team on Compound Development Team.
• Providing strategic guidance and driving cross-functional alignment for programs requiring predictive biomarkers.
• Provide strategic and operational leadership for the development and execution of integrated CDx plans supporting patient selection, therapeutic assessment, regulatory approval and commercial viability of CDx assays, in partnership with CDx SMEs.
• Ensure CDx timelines and deliverables are aligned with clinical development milestones, regulatory submissions, and commercialization plans.
• Present CDx strategy, progress and results to senior leadership, governance committees, and external stakeholders in collaboration with CDx SMEs.
• Lead preparation of presentations to governance committee to support decision-making related to diagnostic strategy, execution, and vendor selection.
• Oversee external diagnostic partnerships in collaboration with Alliance Management, including scope definition, performance oversight, risk management, issue resolution, budget accountability, and working with Joint Steering Committee members.
• Partner with CDTL/ PM of the compound, Clinical Strategy, Precision Medicine, Regulatory Affairs, and Quality functions to ensure alignment with protocol, regulatory, and operational requirements.
• Support inspection readiness and participate in internal and external audits, including regulatory inspections and partner audits.

Requirements:
• Bachelor's degree in Biological Sciences, Bioengineering or a related field, with a minimum of 10 years of experience in diagnostics, pharmaceuticals, or the life sciences industry.
• Seven or more years of experience in project management, portfolio strategy or related leadership roles.
• Experience in oncology and immuno-oncology drug development, with demonstrated success in driving biomarker-based patient selection strategies in hematologic malignancies and/or solid tumors.
• Working knowledge of CDx development processes including analytical and clinical validation strategies, design controls, and global regulatory interactions related to CDx submissions.
• Demonstrated ability to lead cross-functional teams and effectively manage external vendors and strategic partners.
• Demonstrated experience managing complex program budgets and external vendor contracts, with accountability for forecasting, financial planning, and resource allocation.
• Advanced proficiency with Microsoft Project and/or enterprise planning platforms such as Planisware.
• US-based candidates are required. This position is a 60% hybrid presence from our Princeton, NJ office.

For US based candidates, the proposed salary band for this position is as follows:

$194,560.00---$291,840.00

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

Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process