Manager, Clinical Project Planning

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

Benefits offered by this job

Annual bonuses

Equity awards

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an accomplished Clinical Project Planning Manager to drive end-to-end planning for global clinical trials from Phase 1 through NDA/BLA submission.

You will develop timelines, perform critical path analyses, and ensure data integrity across Planisware-driven workflows. The role requires leading cross-functional collaboration, presenting to senior management, and mentoring planners in a fast-paced pharma environment.

Qualifications

• BS degree and 8+ years in end-to-end clinical trial planning.

Responsibilities

• Develop end-to-end clinical study timelines from Phase 1 through NDA/BLA using Planisware Enterprise or equivalent.
• Perform critical path, schedule risk, and what-if analyses to identify risks and corrective actions.
• Lead base-lining, change control, and data integrity checks for planning workflows.
• Coordinate with cross-functional stakeholders; lead timeline review meetings and action follow-ups.
• Prepare status reports, critical path summaries, and data visuals for senior management.
• Represent CTM in governance forums and be the Planisware expert for questions.
• Support planning across R&D programs and integrated asset development plans.
• Drive monthly planning close and ensure IPPs capture key activities.
• Train and mentor new planners and drive standardization across the organization.

Skills

Planisware

Cross-functional leadership

Critical path analysis

Schedule risk analysis

Data visualization

Executive communication

Project management

GxP knowledge

Education

BS degree

8 years experience

PMP or equivalent

Tools

Planisware Enterprise

Orchestra

Microsoft Project

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.

Location: Armonk, NY or Remote

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

We are committed to building a workplace with an inclusive culture.

Discover your role:

• 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 hyper‑care‑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

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.

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

• 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
• family support benefits

Regeneron is a leading biotechnology company that invents life‑transforming medicines for people with serious diseases. Founded and led for over 30 years by physician‑scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award‑winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

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.