Senior Director, CMC Project Management

Redwood City, CA - USA

Monthly Salary: Not Disclosed

Posted on: 20 hours ago

Vacancies: 1 Vacancy

Job Summary

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys 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 Revolutionariesin a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

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.

Required Skills Experience and Education:

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 Skills:

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.
#LI-Hybrid #LI-CT1

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role level and location. Individual base pay salary is determined by multiple factors including job-related skills experience market dynamics and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed which includes competitive cash compensation robust equity awards strong benefits and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race color religion gender sexual orientation gender identity/expression national origin/ancestry age disability marital status medical condition and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect process and use any personal data that you provide to us in accordance with ourCCPA additional information please contact .

Base Pay Salary Range

$244000$305000 USD

Required Experience:

Exec

The Opportunity:

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.

Required Skills Experience and Education:

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 Skills:

A self-starter with ability to work independently deal with ambiguity and to develop a CMC development strategy in collaboration with other functions.