Senior Director, Clinical Operations

Overview 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 first‑in‑human and pivotal studies. This role oversees end‑to‑end clinical trial execution ensures compliance with FDAEMEA regulations and ICH‑GCP manages CROs and vendors and partners cross‑functionally to deliver high‑quality clinical programs aligned with corporate objectives. The Director also leads Clinical Operations staff drives operational excellence and contributes to program‑level planning across Incytes Hematology Oncology and InflammationAutoimmunity portfolio. Essential Functions of the Job Key responsibilities Provide strategic operational leadership for assigned clinical programs including feasibility resource forecasting and long‑range planning. Contribute to program‑level strategy timelines budgets and operational deliverables in alignment with corporate goals. Ensure harmonized operational plans and high‑quality data across global trials. Lead end‑to‑end planning implementation and management of global Phase I-III trials including first‑in‑human studies. Oversee day‑to‑day clinical operations to ensure adherence to timelines budgets SOPs ICH‑GCP and country‑specific 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 andor participate in cross‑functional study team meetings ensuring alignment and timely decision‑making. 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 high‑quality 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 Bachelors 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 first‑in‑human experience strongly preferred. Oncology experience preferred rare disease experience desirable. Global clinical development experience preferred. Strong knowledge of FDAEMEA regulations ICH‑GCP 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 high‑performing teams. Strong organizational time‑management and problem‑solving skills. Excellent written and verbal communication skills. Thrives in a collaborative fast‑paced high‑energy 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. We Respect Your Privacy Learn more at httpwww.incyte.comprivacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access delete restrict edit move or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incytes data protection practices here. By accessing this link you can learn about the types of personal data we collect how we use it whether collection and processing is optional sources of the personal data we process how it is shared where it is stored or transferred to how long we keep it and contact information for Incyte Incytes data protection officer and your supervisory authority if applicable. Please contact privacyincyte.com if you have any questions or concerns or would like to exercise your rights. VWD