Associate Director, CMC Project Management

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 scientists in 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 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 clinical programs. This role is an individual contributor with team leadership responsibilities, reporting into the Director, CMC Project Management.

• Provide project management support to CMC teams for projects ranging from Pre-IND through different phases of clinical development and commercialization.

• Enable CMC leads and/or functional leads in implementing comprehensive CMC strategies and development plans and driving the CMC timelines to meet projects’ needs.

• Develop, maintain, and track CMC timelines and other relevant documents.

• Collaborate with team members in CMC, QA, and Regulatory Affairs, to execute the CMC projects according to established CMC development plans.

• Coordinate with the Regulatory Affairs team to track, coordinate, and communicate CMC regulatory filing timelines as needed.

• Collaborate with CMC leads to plan and facilitate regular and effective CMC project meetings with structured agendas and accurate meeting minutes; follow up on action items.

• Proactively identify potential key issues and communicate with key stakeholders and management in a timely manner.

• Provide project management support to enable oversight of the development activities outsourced to CDMO(s) as needed.

• Support and facilitate the CMC portfolio review process to support the growing pipeline.

• B.S. or M.S. or a Ph.D. degree in Pharmaceutics, Chemistry, Chemical Engineering, or a closely related field is desirable.

• 10+ years of experience in the pharmaceutical/biotech industry with CMC drug development experience, small molecule drug development experience is preferred.

• Strong CMC project management experience in early and/or late phase development with a good understanding of the drug development cycle, regulatory filings experience a plus.

• Good understanding and experience of CMC considerations with respect to GMP, quality systems, ICH guidelines, FDA, and associated regulatory requirements.

• Demonstrated strong cross-functional project management skills.

• Ability to translate high-level strategies into actionable items.

• Effective team player with an entrepreneurial spirit and leadership skills

• Ability to communicate effectively with team members with a diverse range of backgrounds.

• Excellent written and verbal communication skills and interpersonal skills

• Innovative team player with high energy for our dynamic company environment

Required Skills, Experience and Education:

• B.S. or M.S. or Ph.D. degree in Pharmaceutics, Chemistry, Chemical engineering or closely related field is desirable

• B.S. with 10+ years/M.S with 5-8 years/Ph.D. with 3-5 years’ experience in Pharma/Biotech industry, small molecule development experience preferred

• Strong CMC project management experience for development projects spanning various phases of development with a good understanding of the drug development cycle, regulatory filings experience a plus.

• Knowledge of current International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, GMP guidelines, and related industry practices.

• Working experience and knowledge of regulatory submission (Investigational New Drug (IND), Investigational Medicinal Product Dossier (IMPD), and / or New Drug Application (NDA).

• Demonstrated experience working in cross-functional teams and effective communication across multiple functional areas

• Effective written and verbal communication skills and interpersonal skills

• Ability to interpret complex project information and i