Director, Companion Diagnostic Program Manager

About the role

The Director, Companion Diagnostic Program Manager at Genmab is responsible for leading the development and execution of companion diagnostic assays (CDx) projects across the company's oncology portfolio. This role requires strategic and operational leadership, cross-functional alignment, and compliance with regulatory expectations.

Responsibilities

• Lead the development of CDx strategy for oncology programs from early through late-stage development and global Health Authority approvals in partnership with CDx SMEs.
• Provide strategic guidance and drive cross-functional alignment for programs requiring predictive biomarkers.
• 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.
• 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.