Associate Director- Clinical Trial Management

3 weeks ago

Cambridge, United Kingdom Regeneron Pharmaceuticals, Inc Full time

We are seeking an Associate Director- Clinical Trial Management to join our Oncology team as a part of our new Regeneron Cell Medicines (RCM) group. You will independently lead our clinical study, including planning, maintaining timelines and budgets, vendor management, relationship management between clinical sites and vendors, management of clinical sites, liaise with internal and external collaborators, and identification of project risks and contingency planning.

As an Associate Director- Clinical Trial Management, a typical day might include:

Leading day to day operations of clinical early phase oncology cell therapy studies, overseeing clinical study team management, and maintaining accuracy of information in trial databases and tracking systems

Overseeing external CROs/vendors, study managers, field clinical monitors, and investigative site staff to ensure trial(s) are managed to the highest quality

Forecasting trial resource needs (external costs), being accountable for the trial level clinical operations budget, management, as well as leading development of SOWs, site budgets, CTAs, etc.

Communicating study status, issues, risks, and mitigations to relevant cross-functional teams and leading trial level interactions with relevant external functions and internal functions

Collaborating closely with internal groups to ensure robust plans for trial level data review including trend evaluation

Developing and reviewing critical study documents including informed consent forms, study conduct documents, as well as participating in the development and amendments of protocols, investigator brochures, informed consents, etc.

Performing research site activities, such as site qualification visits, site initiation visits, trainings, and motivational visits

Providing oversight, training, and support for field clinical monitors

This role might be for you if you:

Can work independently and lead a clinical operations team, managing interactions with and between internal and external team members

Have strong attention to detail and excellent verbal and written communication skills

Are able to flexible and shift with changing priorities

In order to be considered for this role, you must have at least a BS/BA/RN in science or a health-related field and 6-8+ years of relevant clinical study management experience. Biotech/pharmaceutical industry or contract research organization experience preferred. We need someone with operational and managerial experience in planning, driving, reporting, and publishing clinical studies in trial and site startup. Experience with Phases 1-4 Oncology trial management required. Oncology monitoring experience preferred. Must have excellent knowledge of GCP, ICH, and FDA regulations. FIH, early development, and pivotal experience preferred. Cellular therapy experience a plus. Must be able to travel up to 25%, including internationally.

Regeneron Cell Medicines (RCM) has been created to advance the next generation of cell therapies and explore combinations with Regeneron’s proprietary antibodies and bispecifics. We are a group of about 160 research, development, manufacturing and clinical employees based in Seattle, WA and Cambridge, MA.

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