Global Clinical Trial Operations Lead

Incyte Corporation; Wilmington (DE); On-site; USD 110,000 - 170,000; Full time

Job summary

Incyte Corporation seeks a Senior Clinical Operations Lead to support the Clinical Trial Manager and operational teams in trial execution. The role involves liaison with CROs and vendors to manage operational tasks and maintain timely communications and status reports with the study team.

Responsibilities include developing trial documents, overseeing site feasibility, coordinating monitoring and deadlines, and contributing to data review and safety coordination.

Qualifications

• BS/BA degree in science or a related field.
• Minimum of five years of experience in biopharma or clinical research.
• Working knowledge of ICH GCP and regulatory requirements.
• Ability to manage multiple priorities across protocols and therapeutic areas.
• Experience in multinational trials is a plus.

Responsibilities

• Assist in reviewing and writing clinical trial documents and manuals.
• Develop and review Master ICF templates and site amendment updates.
• Support feasibility and site evaluations with Clinical Trial Logistics.
• Coordinate monitoring activities and support US monitoring organization.
• Contribute to study timelines, recruitment tools, and patient retention plans.
• Plan investigator meetings, safety calls, and DMC/SMC coordination.
• Assist in IP and co-medication strategies with cross‑functional teams.
• Participate in data review and discrepancy resolution.
• Coordinate with Pharmacovigilance for safety signals.
• Oversee external vendors (monitoring, sample mgmt, IVRS, labs).
• Collaborate with multi-disciplinary trial teams and sites.

Skills

Clinical operations

Project management

Communication

Regulatory knowledge

Education

BS/BA degree in science

Job description

Incyte Corporation seeks a Senior Clinical Operations Lead to support the Clinical Trial Manager and operational teams in trial execution. The role involves liaison with CROs and vendors to manage operational tasks and maintain timely communications and status reports with the study team.

Responsibilities include developing trial documents, overseeing site feasibility, coordinating monitoring and deadlines, and contributing to data review and safety coordination.