Director, Program Operations Leader - Ophthalmology/Renal

About the role

The Program Operations Leader (POL) is responsible for leading and implementing the operational strategy for clinical trial management programs. This includes overseeing clinical operations, managing budgets, and interacting with various stakeholders.

Responsibilities

• Maintain an overview of clinical program status and communicate progress, risks, and issues to stakeholders.
• Provide operational insight into feasibility, timeline, and cost estimates during clinical program/study development.
• Oversee clinical study timelines within a clinical program.
• Develop and implement operational strategy, drive early study planning budget and timelines from Clinical Study Concept through Final Protocol Review.
• Ensure consistency within the program and develop best practices within CTM.
• Manage clinical study budgets within a program, ensuring review, presentation, and approval of initial study budget, and manage the budget through the lifecycle of the program.
• Drive decision-making and integrate all operational considerations for studies within a clinical program to ensure goals are attainable before implementation.
• Review key metrics and KPIs across studies and within clinical program to track study progress.
• Create and implement risk mitigation strategies.
• Provide innovative and flexible operational solutions and options to cross-functional and development teams.
• Manage vendor selection and relationships within a clinical program.
• Manage the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts.

Requirements

• Bachelor's degree
• Minimum 12 years of related in-house sponsor-side pharmaceutical experience
• Minimum 8 years in clinical operations

Qualifications

• Proven leadership experience in clinical operations
• Strong understanding of clinical trial management processes and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to manage multiple projects simultaneously
• Experience with budgeting and financial management
• Knowledge of clinical research organization (CRO) and vendor management

Skills

• Strong organizational and project management skills
• Excellent communication and interpersonal skills
• Ability to manage multiple projects simultaneously
• Strong understanding of clinical trial management processes and regulatory requirements
• Experience with budgeting and financial management
• Knowledge of clinical research organization (CRO) and vendor management

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

Pay

$205,000.00 - $341,600.00 annually

Schedule

This position is on-site 4 days per week and 1 day from home. A fully remote role is not possible for this position.