Senior Director, Clinical Operations

Overview A global biopharmaceutical company on a mission to solve unmet medical needs. Incyte follows science to find solutions for patients with unmet medical needs. Through discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first‑in‑class medicines and a strong pipeline 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 Senior Director, Clinical Operations is responsible for strategic planning, tactical implementation, and reporting of clinical investigations involving human subjects. The role manages clinical studies to ensure compliance with corporate objectives, regulatory requirements, and appropriate guidance. Responsibilities include direction of clinical operations personnel, contract research organizations, consultants, core laboratories, and other study support organizations for assigned trials. The position is accountable for day‑to‑day clinical development operational plans in accordance with budget, timelines, SOP, ICH Good Clinical Practice, and country regulations. Essential Functions (Key Responsibilities) Provide clear objectives, ongoing feedback and end‑of‑performance review for direct reports. Maintain and develop investigator site and key opinion leader relationships. Collaborate closely with clinical development, other internal departments, and external vendors. Contribute to hiring plan and staffing activities, including on‑boarding, training, and mentoring of new employees. Resource studies across the compound, provide updates and status reports to senior management. Align Clinical Trial Heads. Assist in clinical program/trials implementation, including operational feasibility, resource forecast, and management across the compound. Collaborate with senior management to determine clinical supply requirements. Participate in strategy, design, development, and review of clinical trial protocols, amendments, informed consent forms, study guides, case report forms, and other clinical research documents. Prepare clinical contributions to INDs, Investigational Brochure, regulatory briefing documents, and other relevant documentation. Plan, implement and manage Phase I–III clinical trials in collaboration with CRO partners. Prepare clinical trials program timelines, budgets, and key deliverables consistent with departmental and corporate objectives. Assist in preparation of RFP documents and financial analysis of CRO proposal costs and negotiation. Oversee strategic oversight of CRO and other vendors. Develop and write clinical trial program documents and manuals as appropriate. Ensure accurate operational development plans, harmonization, and high data quality across trials. Qualifications Bachelor of Science degree or a degree in a field relevant to a profession in the biopharmaceutical industry. Minimum 8 years of experience in project management and/or clinical operations within biopharmaceutical or CRO environments, with at least 3 years in a primary clinical trial design, execution and management role. Good knowledge of GCPs, clinical trial design, statistics, regulatory processes, and drug development. Proven ability to lead multi‑disciplinary teams. Ability to develop and administer budgets, schedules, performance requirements, and direct resources effectively. Experience developing effective relationships with key investigators. Experience in a relevant therapeutic area; preference in Oncology. Program management experience preferred. Operational and direct managerial experience in planning, executing, and reporting global clinical development trials. Willingness to travel (domestic and international) up to 10%. Disclaimer The above statements describe the general nature and level of work performed by employees assigned to this job and are not an exhaustive list of duties, responsibilities, and qualifications. Management reserves the right to change or modify duties as required. Equal Opportunity Employment Incyte Corporation is committed to creating a diverse environment and is an equal opportunity employer. #J-18808-Ljbffr