Operations Manager, 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)
The Translational Sciences Operations Lead supports our biology research and clinical biomarker programs by facilitating the execution of biomarker operational plans. This position will work in a collaborative matrix environment focused on delivering impactful translational data in human clinical studies.

Essential Functions of the Job (Key responsibilities)

• Play a key role in the communication and integration of translational sciences objectives with clinical study team members during protocol development and execution.
• Take a leadership role in onboarding, training, and supporting new employees responsible for the tactical execution of biomarker sample collection and analysis during clinical protocol development, study start-up, and amendments, including contributing to and reviewing protocols, lab manuals, and clinical laboratory worksheets (CLW).
• Serve as a member of the Translational Sciences clinical study start team; support the tactical execution of biomarker sample collection and analysis during clinical protocol development, study start-up and amendments, including contribution to and review of protocols, lab manuals, and clinical laboratory worksheets (CLW) and communicate information as required to other departments within the organization and external partners (if appropriate); take part in program meetings with central lab, clinical, operations and data management.
• Contribute to activities involving the Data Management team, including eCRF set-up, database build for sites and sample tracking/reconciliation
• Lead the efforts to standardize nomenclature, pictograms, sample handling instructions, and resources for all central labs to ensure consistency across studies, welcoming diverse perspectives and inclusive practices.
• Aid in the process development and coordination of informed consent form tracking and clinical program sample storage/tracking using in-house and commercial systems
• Participate in vendor meetings to stay informed of current and upcoming projects, new technologies, and vendor offerings. Attending meetings at various locations as needed, with accommodation available for those who require it.
• Solve problems independently, reaching out to internal or external clients as needed, while fostering a collaborative and inclusive environment.
• Must be able to prioritize workload in response to the specific needs of numerous protocols and department.
• Maintain awareness of local and international regulations as pertains to protecting the privacy of personal information that may be associated with clinical samples.
• Participate in process improvement initiatives. Plan and implement procedures and systems to maximize operating efficiency.

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

• Scientific background (BS, RN, Med Tech) with relevant experience in clinical drug development or clinical trial execution, including exposure to biomarkers, pharmacokinetics, or immunogenicity sample activities, sample collection procedures, logistics considerations, and informed consent language specific to the handling of human tissue specimens. We welcome candidates with diverse experiences and encourage those who may not have the exact years of experience to apply.
• An understanding of the drug development process and familiarity with clinical labs
• Experience collaborating with Contract Research Organizations (CROs).
• Demonstrated knowledge of ICH and GCP
• Proficiency in Microsoft Office programs, Smartsheet, and familiarity with electronic data systems and controlled sample management systems.
• Detailed and precise record keeping skills are essential as well as the ability to track and resolve issues
• Excellent teamwork and ability to collaborate with cross functional teams
• Excellent interpersonal, written, and verbal communication skills.
• Strong time management, planning, and organizational skills.
• Able to manage multiple projects at once, effectively organizing tasks to meet deadlines while working both independently and collaboratively to achieve goals.

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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