Regeneron
DirectorProgramOperationsLeader
Neural analysis suggests this role is
optimal for Director candidates.
“Director Program Operations Leader at Regeneron. Skills: Program Operations, Clinical Trials. Lead operational strategy for programs. Implement operational strategy for programs”
What You'll Achieve.
Ensure timely delivery of quality deliverables
Industry & Context.
Risk mitigation; Problem solving
Up to 25% travel
What They're Looking For.
Must Have
Bachelor's degree, 12 years in-house sponsor-side pharmaceutical experience, 8 years in clinical operations
What You'll Do.
Lead operational strategy for programs
Implement operational strategy for programs
Manage clinical operations activities
Ensure quality of clinical research
Ensure timelines of clinical research
Ensure budgets of clinical research
Adhere to regulations and SOPs
Interact with senior management
Interact with external vendors
Interact with collaboration partners
Manage clinical trial staff
Recruit clinical trial staff
Develop clinical trial staff
Coach clinical trial staff
Mentor clinical trial staff
Manage performance of staff
Drive functional strategy
Oversee clinical study team success
Maintain program status overview
Communicate program progress
Communicate program risks
Communicate program issues
Communicate program changes
Provide program updates to stakeholders
Provide operational insight for estimates
Oversee study timelines
Provide operational insight into CSCs
Develop operational strategy
Implement operational strategy
Drive study planning budget
Drive study planning timelines
Review protocol design plans
Provide clinical operations expertise
Ensure consistency within program
Develop best practices within CTM
Oversee study budgets
Present initial study budget
Approve initial study budget
Manage budget through lifecycle
Communicate budget changes
Ensure timely delivery of deliverables
Ensure quality of deliverables
Ensure consistency of process
Ensure consistency of approaches
Drive decision making
Integrate operational considerations
Act as escalation point of contact
Create risk mitigation strategies
Implement risk mitigation strategies
Provide innovative operational solutions
Provide flexible operational solutions
Assist in preparing scenarios
Drive vendor selection strategy
Drive vendor management strategy
Manage CRO relationship
Manage vendor relationship
How You'll Work.
Team & Collaboration
Clinical Trial Management leadership; Cross-functional teams; Development teams
Communication Scope
Stakeholder communication; Program updates
Process & Methodology
Clinical program management, Study planning
Full Job Description
The **Director Program Operations Leader** (POL) is responsible for leadership of and setting and implementation of the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is 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 and company Standard Operating Procedures (SOPs) within assigned program(s). The 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 POL is responsible for line management of clinical trial management staff (including AD POL), and has responsibility for staff recruitment, development, coaching, mentoring and performance management. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership. The Director POL is expected to operate with autonomy and high-degree of independence. **Director Program Operations Leader - Internal Medicines** **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/study development * Oversee clinical study timelines within a clinical program(s) * Provide input and operational insight into Clinical Study Concepts (CSC) * Be responsible for development and implementation of operational strategy, driving early study plannin
Applying for this Director Program Operations Leader role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Regeneron?
Real rants from real employees. Read before you apply.