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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 Summary (Primary function)

The Director, Clinical Operations provides strategic, operational, and people leadership for global Phase I-III clinical trials, including firstinhuman and pivotal studies. This role oversees endtoend clinical trial execution, ensures compliance with FDA/EMEA regulations and ICHGCP, manages CROs and vendors, and partners crossfunctionally to deliver highquality clinical programs aligned with corporate objectives. The Director also leads Clinical Operations staff, drives operational excellence, and contributes to programlevel planning across Incyte's Hematology, Oncology, and Inflammation/Autoimmunity portfolio.

Essential Functions of the Job (Key responsibilities)

• Provide strategic operational leadership for assigned clinical programs, including feasibility, resource forecasting, and longrange planning.

• Contribute to programlevel strategy, timelines, budgets, and operational deliverables in alignment with corporate goals.

• Ensure harmonized operational plans and highquality data across global trials.

• Lead endtoend planning, implementation, and management of global Phase I-III trials, including firstinhuman studies.

• Oversee daytoday clinical operations to ensure adherence to timelines, budgets, SOPs, ICHGCP, and countryspecific regulations.

• Manage investigational product accountability and reconciliation processes.

• Support preparation of safety updates, interim analyses, and final clinical study reports; resolve data discrepancies.

• Partner closely with Clinical Development, Regulatory, Biometrics, Supply Chain, and other internal teams to achieve study objectives.

• Lead and/or participate in crossfunctional study team meetings, ensuring alignment and timely decisionmaking.

• Collaborate with senior management to determine clinical supply requirements and operational strategy.

• Select, negotiate, and manage CROs and external vendors (central labs, EDC providers, patient recruitment partners, etc.).

• Develop RFPs, conduct cost analyses, and ensure vendor performance meets quality, timeline, and budget expectations.

• Provide strategic oversight of CRO governance and issue resolution.

• Contribute to the development and review of protocols, amendments, ICFs, CRFs, study guides, operational plans, and charters.

• Participate in preparation of INDs, Investigator Brochures, regulatory briefing documents, and other clinical submissions.

• Ensure operational feasibility and highquality clinical data across studies.

• Build and maintain strong relationships with investigator sites, KOLs, patient advocacy groups, and referral networks.

• Support site engagement strategies to ensure enrollment targets and study goals are met.

• Recruit, manage, and mentor Clinical Trial Managers, Clinical Trial Specialists, and other direct reports.

• Provide clear objectives, ongoing coaching, and performance evaluations.

• Foster a culture of engagement, accountability, and collaboration.

• Provide regular updates and status reports to senior leadership.

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

• Bachelor's degree in Life Sciences or related field required.

• 10+ years of clinical operations experience in biopharma or biotech.

• Minimum 5 years of direct clinical study management experience.

• Extensive experience managing global Phase I-III trials; firstinhuman experience strongly preferred.

• Oncology experience preferred; rare disease experience desirable.

• Global clinical development experience preferred.

• Strong knowledge of FDA/EMEA regulations, ICHGCP, and clinical trial methodology.

• Proven ability to manage CROs and external vendors.

• Experience with clinical systems (EDC, CTMS, eTMF) and operational documentation.

• Demonstrated ability to manage budgets, timelines, and complex operational plans.

• Proven ability to lead and develop highperforming teams.

• Strong organizational, timemanagement, and problemsolving skills.

• Excellent written and verbal communication skills.

• Thrives in a collaborative, fastpaced, highenergy environment.

• Ability to travel domestically and internationally (up to 30%).

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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