Director, Companion Diagnostic Program Manager

Director, Companion Diagnostic Program Manager

Position in Program Management function, responsible for providing strategic and operational leadership for planning, development, validation, and execution of companion diagnostic assays (CDx) projects across our oncology portfolio. The role leads CDx sub-teams, partners with CDx SMEs to ensure CDx strategy is integrated into Compound Development Plan and Target Product Profile. Deliver compliant, high-quality diagnostic solutions aligned with clinical development timelines and regulatory expectations.

Reports to the Head of Program Management and works closely with colleagues from Translational & Quantitative Sciences, Clinical Strategy, Regulatory, Commercial, Market Access and external diagnostic collaborators.

• Lead 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.
• Lead strategic and operational leadership for development and execution of integrated CDx plans supporting patient selection, therapeutic assessment, regulatory approval and commercial viability of CDx assays.
• Ensure CDx timelines and deliverables align with clinical development milestones, regulatory submissions, and commercialization plans.
• Present CDx strategy, progress and results to senior leadership, governance committees and external stakeholders.
• Lead preparation of presentations to governance committee to support decision-making related to diagnostic strategy, execution and vendor selection.
• Oversee external diagnostic partnerships including scope definition, performance oversight, risk management, issue resolution, budget accountability and collaboration with Joint Steering Committee members.
• Collaborate with CDTL/PM, 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.

• Bachelor’s degree in Biological Sciences, Bioengineering or related field, with a minimum of 10 years of experience in diagnostics, pharmaceuticals or 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.
• 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 required. The position offers flexible work arrangement, including remote work or a hybrid presence from Princeton, NJ or Boston, MA offices.

Proposed salary band: $ – $. Actual offer will consider skills, qualifications, experience and location. Certain positions eligible for discretionary bonuses and long-term incentives.

• 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 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