Director / Associate Director Companion Diagnostics Lead, Translational Sciences
Incyte
July 01, 2026
Remote friendly (Wilmington, DE)
United States
Clinical Research and Development
Associate Director, Companion Diagnostics Lead
Responsibilities
- Serve as subject matter expert for companion diagnostics (CDx) development (concept to commercialization)
- Lead selection and management of diagnostic partners; act as alliance and project manager
- Monitor assay analytical/clinical performance evaluation activities
- Author CDx-related sections across documents; ensure CDx representation in cross-functional teams
- Generate/review project agreements
- Manage CDx budgets; track/approve milestones
- Lead Joint Project Team (JPT) meetings with alliance partners
- Supervise validation and clinical trial assay (CTA) implementation at testing laboratories; maintain alignment between partners and testing labs
- Oversee operational aspects of clinical implementation
- Ensure compliance with regulatory/ethical guidelines
- Apply CDx regulatory requirements across regions (e.g., US FDA, EU IVDR)
- Supervise review of CDx documentation (e.g., CPSP, Instructions for Use)
- Ensure informed consent, CPSP, and country submissions/responses are timely and compliant
- Develop/maintain expertise in CDx delivery; maintain relationships with key stakeholders
Qualifications
- Minimum BS in a scientific discipline with 7+ years’ experience in diagnostics and/or pharmaceutical industry (clinical studies)
- Understanding of GCP and relevant regulatory requirements; ability to manage external research activities via CROs/collaborators
- Ability to balance multiple tasks to meet program goals
- High emotional intelligence and collaborative mindset
- Exceptional verbal and written communication skills
Preferred Qualifications
- Advanced degree with extensive experience in CDx development, registration, commercialization, and IVD clinical studies
- Knowledge of assay development using NGS, PCR, and immunohistochemistry
- Experience in CDx/precision medicine, including IVDR
Responsibilities
- Serve as subject matter expert for companion diagnostics (CDx) development (concept to commercialization)
- Lead selection and management of diagnostic partners; act as alliance and project manager
- Monitor assay analytical/clinical performance evaluation activities
- Author CDx-related sections across documents; ensure CDx representation in cross-functional teams
- Generate/review project agreements
- Manage CDx budgets; track/approve milestones
- Lead Joint Project Team (JPT) meetings with alliance partners
- Supervise validation and clinical trial assay (CTA) implementation at testing laboratories; maintain alignment between partners and testing labs
- Oversee operational aspects of clinical implementation
- Ensure compliance with regulatory/ethical guidelines
- Apply CDx regulatory requirements across regions (e.g., US FDA, EU IVDR)
- Supervise review of CDx documentation (e.g., CPSP, Instructions for Use)
- Ensure informed consent, CPSP, and country submissions/responses are timely and compliant
- Develop/maintain expertise in CDx delivery; maintain relationships with key stakeholders
Qualifications
- Minimum BS in a scientific discipline with 7+ years’ experience in diagnostics and/or pharmaceutical industry (clinical studies)
- Understanding of GCP and relevant regulatory requirements; ability to manage external research activities via CROs/collaborators
- Ability to balance multiple tasks to meet program goals
- High emotional intelligence and collaborative mindset
- Exceptional verbal and written communication skills
Preferred Qualifications
- Advanced degree with extensive experience in CDx development, registration, commercialization, and IVD clinical studies
- Knowledge of assay development using NGS, PCR, and immunohistochemistry
- Experience in CDx/precision medicine, including IVDR