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Associate Director, CMC Project Manager

Location: Redwood City
Posted on: September 16, 2023

Job Description:

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. Playing a critical role as a CMC Project Manager within Pharmaceutical Development and Manufacturing (PDM) organization, the position will be responsible for managing cross-functional CMC project activities, timelines, and enabling CMC project leads and/or functional leads in driving the development and execution of the CMC development strategies and plans. The Opportunity: 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. Required Experience, Skills, and Education: 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. Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company's offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law. The expected salary range for this role is $160,000 to $200,000. An individual's position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. Base salary 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 Notice andPrivacy Policy .For additional information, please .

Keywords: THIRD ROCK VENTURES, LLC, Redwood City , Associate Director, CMC Project Manager, Executive , Redwood City, California

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