Manager, Clinical Project Planning

Regeneron Pharmaceuticals; Armonk (NY); Hybrid; USD 115,000 - 187,000; Full time

Job summary

Regeneron Pharmaceuticals in Armonk, NY is seeking an accomplished Clinical Project Planning Manager to lead end-to-end study planning and scheduling for global trials. You will coordinate with Clinical Operations, Regulatory, and Program Leadership to deliver integrated project plans using Planisware Enterprise.

Responsibilities include developing cross-functional timelines, conducting critical path and risk analyses, presenting status updates to senior management, and ensuring data integrity

Qualifications

• End-to-end clinical trial planning experience across Phases 1-4.
• Proficiency with Planisware Enterprise and/or Orchestra.
• Strong command of Microsoft Project, MS Office Suite, SharePoint, OnePager and OneNote.
• Deep understanding of drug development including regulatory affairs and clinical supply management.
• PMP or equivalent certification.

Responsibilities

• Develop, implement, and maintain end-to-end cross-functional timelines from Phase 1 to NDA/BLA using Planisware or equivalent.
• Perform critical path, schedule risk, and scenario analyses to identify risks and drive corrective actions.
• Lead baseline and re-baseline processes with CDU and Program Leadership and ensure data integrity in planning workflows.
• Influence cross-functional stakeholders, lead timeline review meetings, and present status updates to senior management.
• Support planning activities across R&D programs and drive monthly planning close with IPPs.

Skills

End-to-end study planning

Cross-functional collaboration

Executive communication

Education

BS degree

Tools

Planisware Enterprise

Orchestra

Microsoft Project

MS Office Suite

SharePoint

OnePager

OneNote

Job description

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 accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$114,800.00 - $187,400.00