Director of Companion Diagnostics — Oncology Programs

Genmab; Princeton (NJ); Hybride; USD 195 000 - 292 000; Plein temps

Avantages offerts par ce poste

401(k) match

Health benefits

Dental & vision insurance

Paid time off

Parental leave

Commuter benefits

Tuition reimbursement

Lifestyle Spending Account

Résumé du poste

Genmab is seeking a Director, Companion Diagnostic Program Manager to provide strategic and operational leadership for planning, development, validation, and execution of companion diagnostic assays across our oncology portfolio. You will lead CDx sub-teams with SMEs to ensure CDx strategy is integrated into development plans and meets regulatory expectations, reporting to the Head of Program Management.

This role requires building strong collaborations with Regulatory, Clinical Strategy, and

Qualifications

• Bachelor’s degree in Biological Sciences, Bioengineering or a related field.
• 10+ years of experience in diagnostics, pharmaceuticals, or life sciences.
• Seven or more years in project management or portfolio strategy with leadership responsibilities.
• Experience in oncology and immuno-oncology drug development and biomarker-based patient selection.

Responsabilités

• Lead development of CDx strategy for oncology programs from early through late-stage development and global Health Authority approvals.
• Provide strategic guidance and drive cross-functional alignment for programs requiring predictive biomarkers.
• Oversee execution of integrated CDx plans supporting patient selection, regulatory approval and commercial viability of CDx assays.

Connaissances

Project Leadership

Cross-functional Collaboration

Strategic Planning

Biomarker Strategy

Vendor Management

Budget Management

Presentation to Leadership

Formation

Bachelor’s degree in Biological Sciences or Bioengineering

Outils

Microsoft Project

Planisware

Description du poste

Genmab is seeking a Director, Companion Diagnostic Program Manager to provide strategic and operational leadership for planning, development, validation, and execution of companion diagnostic assays across our oncology portfolio. You will lead CDx sub-teams with SMEs to ensure CDx strategy is integrated into development plans and meets regulatory expectations, reporting to the Head of Program Management.

This role requires building strong collaborations with Regulatory, Clinical Strategy, and