Companion Diagnostics Operations Assoc. Director/Director, Translational Sciences

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary function)

Companion Diagnostics Operations Director is responsible for overseeing the execution of clinical diagnostic plans for late-stage drug development programs. This involves managing logistics, vendor relationships, and ensuring timely CDx delivery.

Essential Functions of the Job (Key responsibilities)

* Serve as alliance and project manager between key diagnostic partners

o Generate and review new project agreements as needed

o Manage and maintain CDx budget for projects

o Track and approve milestones for each project

o Lead Joint project team (JPT) meetings with alliance partner

o With input from clinical trial managers, maintain projections for GMP kit manufacturing based on patient projections across multiple trials

* Direct validation and implementation of clinical trial assay (CTA) at testing laboratory

o Maintain alignment between diagnostics partner and testing laboratory

o Oversee validation of CTA at testing laboratory

o Ensure timelines for first patient tested are met

o Oversee operational aspects of clinical implementation

* Portal set up, Patient reports, Analytical Plan, Requisition forms, Lab manual, DTA,

* Ensure compliance with regulatory and ethical guidelines

o Develop expertise in regulatory requirements for CDx

o Supervise Incyte review of clinical study performance plans (CPSP)

* Obtain sufficient input from clinical scientists, medical lead, regulatory leads, IVDR consultants

o Ensure regulatory 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

o Translational lead is responsible for strategy, need to align execution with strategy; work closely to maintain alignment

o Clinical trial managers/Clinical asset lead- need to represent CDx execution on study teams. Need to align timelines, countries, regulations

o Project manager- Need to ensure timelines for CDx approval are aligned with therapeutic approval

o Regulatory lead- need to ensure regulations are met and oversee submission timelines and timely responses for each country

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

* Minimum BS Degree in a scientific discipline with 7+ years of experience in clinical studies.

* Understanding of Good Clinical Practices (GCP) and other 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 IVD clinical studies.

* Extensive knowledge of Next Generation Sequencing 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.

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