Director / Associate Director Companion Diagnostics Lead, Translational Sciences

Director / Associate Director Companion Diagnostics Lead, Translational Sciences

A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.

Job Description

Associate Director, Companion Diagnostics Lead is a leadership role responsible for the development and implementation of clinical diagnostic plans including companion diagnostics (CDx) requirements within drug development programs. This involves active participation in CDx strategy setup and deployment, managing logistics, vendor selection and relationships, and ensuring timely CDx delivery.

Key duties include:

• Serve as subject matter expert in CDx development process (from concept to commercialization)
• Lead selection and management of diagnostic partners
• Monitor assay analytical and clinical performance evaluation activities
• Author CDx related parts across documents
• Ensure CDx representation in cross-functional teams
• Serve as alliance and project manager between Incyte and key diagnostic partners
• Generate and review new project agreements as needed
• Manage and maintain CDx budget for projects
• Track and approve milestones for each project
• Lead Joint project team (JPT) meetings with alliance partner
• Supervise validation and implementation of clinical trial assay (CTA) at testing laboratory
• Maintain alignment between diagnostics partner and testing laboratory
• Ensure timelines are met
• Oversee operational aspects of clinical implementation
• Ensure compliance with regulatory and ethical guidelines
• Develop and apply expertise in regulatory requirements for CDx across regions (US FDA, EU IVDR etc)
• Supervise Incyte review of CDx documentation such as clinical study performance plans (CPSP), Instructions for Use etc
• Ensure creation and review of informed consent, CPSP and country submissions/responses are timely and compliant
• Develop and Maintain Expertise in Delivery of Companion Diagnostics
• Maintain relationships with key stakeholders

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Minimum BS Degree in a scientific discipline with 7+ years of experience in the diagnostic and/or pharmaceutical industry (clinical studies).
• Understanding of Good Clinical Practices (GCP) and relevant regulatory requirements. Ability to manage external research activities through CROs and collaborators.
• Ability to balance execution of multiple tasks to accomplish program goals.
• A high level of emotional intelligence and willing to work closely and collaboratively with other functional groups internal and external to the company.
• Exceptional verbal and written communication skills.

Preferred Qualifications:

• Advanced degree in a scientific discipline with extensive experience in CDx development, registration and commercialization and IVD clinical studies.
• Extensive knowledge of assay development using Next Generation Sequencing, PCR and Immunohistochemistry.
• Experience in CDx and/or precision medicine including IVDR.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.