Manager, Clinical Project Planning

Regeneron Pharmaceuticals, Inc. • armonk, ny, United States • $140 - $190 / year • 4h ago

Build our future together:

We are seeking an accomplished Clinical Project Planning Manager to join our Clinical Development organization. This role is critical to the successful planning, scheduling, and execution of global clinical trials across our pipeline. The ideal candidate has end-to-end clinical study planning experience, a proven track record managing complex cross-functional programs in pharma or biotech, and proficiency in enterprise planning tools such as Planisware. You will serve as a central planning resource across Clinical Trial Management, partnering with Clinical Operations Project Management, Regulatory, Clinical Supply, and Program Leadership to deliver high-quality data and integrated project plans that drive strategic decisions and milestone delivery.

When & Where:

Location: Armonk, NY or Remote
Work Model: Primarily on site with hybrid flexibility, or Remote

Discover your role:

Clinical Study Planning & Scheduling

Develop, implement, and maintain end-to-end (E2E) cross-functional clinical study timelines from Phase 1 through NDA/BLA submission using Planisware Enterprise or equivalent, including schedule baselines and formal change control
Perform critical path, schedule risk, and scenario ("what-if") analyses to identify risks, assess milestone achievability, and propose corrective actions
Perform system quality and data integrity checks, troubleshoot automated study creation and protocol generation workflows, and lead the FAP baseline and re-baseline process with CDU and Program Leadership

Stakeholder Collaboration & Communication

Influence and align cross-functional stakeholders without direct authority; lead timeline review meetings and follow up on action items
Prepare and present status reports, critical path summaries, and data visualizations to senior management and governance committees, proactively communicating schedule risks, variances, and impacts to timelines, resources, and budget
Represent CTM in North Star governance forums (Navigator Change Agent Forum and Planning Capability Forum) and serve as CTM's primary point of contact for Planisware questions, including office hours and hypercare-style support

Portfolio & Program Management

Support planning activities across R&D programs and clinical studies, including integrated asset development plans spanning clinical, regulatory, CMC, and supply chain
Drive the monthly planning close and ensure Integrated Project Plans (IPPs) accurately capture key activities and milestones through regular audits
Serve as CTM's data steward for planning systems and contribute to program-level resource and FTE forecasting

Process Improvement & Knowledge Sharing

Identify and implement best practices and improvements to planning templates and scheduling processes; manage planning tool administration (Planisware Enterprise and/or Orchestra)
Create and maintain planning guidance, job aids, and self-service resources (e.g., North Star Academy) to sustain adoption
Train and mentor new planners, clinical trial managers, and system users, and drive standardization of planning practices across the organization

This role requires:

A minimum of a BS degree and 8 years of experience; Demonstrated expertise in end-to-end clinical trial planning across Phases 1-4
Proficiency in Planisware Enterprise and/or Orchestra
Strong command of Microsoft Project, MS Office Suite, SharePoint, OnePager, and OneNote
Deep understanding of drug development, including clinical operations, regulatory affairs, and clinical supply management
Proven ability to manage complex, global, cross-functional programs in a fast-paced environment
Exceptional communication and presentation skills; ability to influence without authority
Experience with critical path analysis, schedule risk analysis, and scenario planning
Knowledge of complex clinical programs (e.g., oncology, cell therapies, genetic medicine) and of Regulatory CMC planning or Clinical Supply Management
Familiarity with change control processes and IPP management
PMP or equivalent certification
Experience in both large pharma and biotech/startup environments
Proficiency in data visualization and executive-level presentations

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.

Where required, we will provide reasonable accommod

#J-18808-Ljbffr