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Associate Director/Director, Clinical Operations

3 months ago

Hartford, United States Atlas Search Full time

We are currently partnered with a fast growing pharmaceutical company that is seeking an Associate Director/Director of Clinical Operations. This is a great opportunity to become part of a company at the forefront of advancing CAR-T cellular therapy through innovative platforms engineered to offer superior safety, effectiveness, and accessibility when compared to traditional autologous CAR T therapies. Responsibilities The AD/Director, Clinical Operations will manage clinical trial(s) in coordination with the clinical study team and venders. As a member of the Clinical Operations Team, the AD/Director, Clinical Operations is responsible for operational planning and oversight of all study activities and escalates issues when needed from study concept through finalization of clinical study reports. The candidate will ensure clinical study/studies are executed within projected budget, on time, and with high quality and is expected to: Manage/oversee the conduct and execution of an assigned clinical trial(s) and associated activities in accordance with Good Clinical Practices (GCP), Cell Therapy (CT) regulations and relevant national and international requirements. Manage complex CAR-T clinical trial(s) Prepare clinical research budgets and timelines Responsible for the identification, review and selection of appropriate vendors and investigational sites. Responsible for management and oversight of CROs, and selected study vendors; ensuring all vendors meet the predetermined program milestones according to budget and time Works closely with study team to prepare and maintain manuals, forms, plans and documents, and participates in internal cross-functional study team meetings. Contribute to the writing and review of clinical documents such as protocols, informed consents, investigator brochures, and clinical study reports. Lead study start up process and cross functional planning in support of study start up Qualifications: Bachelor’s degree (or equivalent) in a relevant scientific field preferred. Minimum of 10 years of clinical trial experience including clinical trial management, in pharmaceutical, biotech or CRO setting CAR-T (Oncology/Hematology) experience required

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