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Senior Director, CMC Project Management jobs in United States
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Revolution Medicines · 6 hours ago

Senior Director, CMC Project Management

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies. They are seeking a motivated individual to manage cross-functional CMC project management activities in support of their pipeline compound development and commercial products, with responsibilities including strategic project management support and collaboration with various teams.
Health CareLife ScienceMedical
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H1B Sponsor Likelynote

Responsibilities

Provide strategic project management support to CMC teams for projects in late phase development leading to global commercial launch readiness and commercial life cycle management
Drive creation of integrated CMC launch readiness plans covering PPQ, validation, site readiness, labeling/packaging, launch inventory, and inspection preparedness
Drive CMC readiness for global regulatory submissions and launches including NDA/MAA/JNDA and post approval activities
Partner with Supply Chain and Operations function to define and execute robust CMC strategies ensuring alignment across technical, regulatory, quality, and supply milestones
Work collaboratively with cross-functional team including CMC leads, functional leads, Business Operations, Supply Chain and Quality to develop timelines for PDM activities related to commercial launch
Provide CMC PM support to cross-functional team to plan and facilitate regular and effective launch preparation meetings with structured agendas and accurate meeting minutes; follow up on action items
Provide CMC PM support for interactions with CMOs in support of global launch and commercial supply
Provide CMC PM support for marketed products, including post-approval changes, tech transfers, and capacity expansions
Participate in the CMC portfolio review process to support the growing pipeline, providing input to senior management
Proactively identify potential key issues and communicate with key stakeholders and management in a timely manner

Qualification

CMC project managementSmall molecule developmentRegulatory submissionsICH guidelinesGMP guidelinesStrategic leadershipAgility in project managementCross-functional team leadershipIndependent work

Required

B.S. or M.S. or Ph.D. degree in Pharmaceutics, Chemistry, Chemical engineering or closely related field
A minimum of 12 years CMC project management experience with small molecule development experience
Demonstrated experience of project management for projects that have led to successful regulatory approvals and commercial launch
Demonstrated experience working with external development partners is a plus
Knowledge of current ICH guidelines, GMP guidelines, and related industry practices
Working experience and knowledge of regulatory submissions (IND, IMPD, NDA and MAA)
Demonstrated strong cross-functional team and strategic leadership skills

Preferred

A self-starter with ability to work independently, deal with ambiguity and to develop a CMC development strategy in collaboration with other functions
Ability to interpret complex project information and demonstrate agility in responding to changing project needs

Benefits

Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities

Company

Revolution Medicines

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Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.

H1B Sponsorship

Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$2.25B
Key Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M

Leadership Team

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Luan Wilfong
Chief Human Resources Officer
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Steve Kelsey
President
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Company data provided by crunchbase