Senior Director, CMC Project Management

Revolution Medicines•Redwood City, CA

12h•Onsite

About The Position

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. Revolution Medicines is seeking a motivated individual with a scientific background to add to the CMC Project Management (PM) team within the PDM function (Pharmaceutical Development and Manufacturing). This position will be responsible for managing cross-functional CMC project management activities in support of Revolution Medicines’ pipeline compound development and commercial products. This role will have people management responsibilities along with team leadership responsibilities, reporting into the Executive. Director, CMC Project Management. 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.

Requirements

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.
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.

Nice To Haves

Demonstrated experience working with external development partners is a plus.
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.

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.