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Director, program operations leader - early phase clinical trials

Cambridge
Regeneron Pharmaceuticals, Inc
Director
Posted: 9 September
Offer description

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Director, Program Operations Leader - Early Phase Clinical Trials, Cambridge

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Client:


Location:

Cambridge, United Kingdom


Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

5a500c4600a0


Job Views:

7


Posted:

25.08.2025


Expiry Date:

09.10.2025

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Job Description:

For US Locations, this position is on-site 4 days per week and 1 day from home. For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position.

The Director Program Operations Leader (POL) is responsible for leadership and overallstrategic management of one or more complex programs in Clinical Trial Management (CTM). This individualis responsible for clinical operations activities and decisions including quality, timelines and budgets related to
the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations andcompany Standard Operating Procedures (SOPs) within assigned program(s). The Dir POL is a member of the
Clinical Trial Management extended leadership team, and as such interacts with senior level management,external vendors, collaboration partners and clinical study personnel for clinical research project and department
initiatives. The Dir POL is responsible for line management of clinical trial management staff, includingresponsibility for staff recruitment, development, coaching, mentoring, and performance management.

In a typical day, you will:
• Be responsible for the overall success of the clinical study team(s) within a program(s)
• Maintain an overview of clinical program(s) status and issues and proactively communicates progress,risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level
updates to stakeholders as requested
• Provide operational insight into feasibility, timeline and cost estimates during clinical program/studydevelopment
• Oversee clinical study timelines within a clinical program(s)
• Provide input and operational insight into Clinical Study Concepts (CSC)
• Review of plans and provision of clinical operations expertise during protocol design, feasibility, studystart up and conduct phases of studies. Ensure consistency within the program and development of best
practices within CTM
• Oversee clinical study budgets within a program: ensures review, presentation and approval of initial
study budget and manages the budget through the lifecycle of the program by communicating changes toTA Operations Leader, as appropriate
• Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency ofprocess and approaches across clinical study teams within the clinical program(s).
• Drives decision making and integrates all operational considerations for studies within a clinicalprogram(s) to ensure goals are attainable prior to implementation
• Be responsible for direct supervision of CTM staff. Line management responsibilities include: workassignments, performance management, staff recruitment, professional development, coaching,mentoring, ongoing training and compliance, and study support/oversight.

To be considered, you must possess:

A Bachelor’s degree and minimum of 12 years relevant in-house sponsor-side industry experience, 8 years within clinical operations.


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