Incyte · 2 days ago
Companion Diagnostics Operations Assoc. Director/Director, Translational Sciences
Wilmington, DE
Full-time
Onsite
Director/Executive
7+ years expIncyte 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. The Companion Diagnostics Operations Director is responsible for overseeing the execution of clinical diagnostic plans for late-stage drug development programs, including managing logistics and vendor relationships to ensure timely CDx delivery.
BiotechnologyHealth CareMedicalMedical DevicePharmaceutical
Responsibilities
Serve as alliance and project manager between 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
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
Maintain alignment between diagnostics partner and testing laboratory
Oversee validation of CTA at testing laboratory
Ensure timelines for first patient tested are met
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
Develop expertise in regulatory requirements for CDx
Supervise Incyte review of clinical study performance plans (CPSP)
Obtain sufficient input from clinical scientists, medical lead, regulatory leads, IVDR consultants
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
Translational lead is responsible for strategy, need to align execution with strategy; work closely to maintain alignment
Clinical trial managers/Clinical asset lead- need to represent CDx execution on study teams. Need to align timelines, countries, regulations
Project manager- Need to ensure timelines for CDx approval are aligned with therapeutic approval
Regulatory lead- need to ensure regulations are met and oversee submission timelines and timely responses for each country
Qualification
Required
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
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
Company
Incyte
Incyte is a drug discovery and development company which hopes to build a proprietary product pipeline of novel small molecule drugs.
1001-5000 employees
H1B Sponsorship
Incyte has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (34)
2023 (32)
2022 (39)
2021 (36)
2020 (24)
Funding
Current Stage
Public CompanyTotal Funding
unknown1996-01-16IPO
Leadership Team
Bill Meury
President & CEO
Jim Lee
Group Vice President, Head Inflammation and AutoImmunity Group
Recent News
2026-01-06
2026-01-05
Company data provided by crunchbase