Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.
Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.
Revolution Medicines is seeking a motivated individual with a scientific background and project management experience to add to the CMC Project Management team within the PDM function (Pharmaceutical Development and Manufacturing). This position will be responsible for managing cross-fuctional 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 Associate Director, CMC Project Management.
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Provide project management support to CMC teams for projects ranging from Pre-IND through different phases of clinical development and commercialization.
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Track CMC timelines, deliverables and other relevant documents.
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Collaborate with team members in PDM, QA, clinical and non-clinical development teams to ensure project activities are progressing within established timelines
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Coordinate with the Regulatory Affairs team to track, coordinate, and communicate CMC regulatory filing timelines as needed.
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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.
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Proactively identify potential key issues and communicate with key stakeholders and management in a timely manner.
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Provide project management support to enable oversight of the development activities outsourced to CDMO(s) as needed.
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B.S with 10+ years/M.S with 5-8 years/Ph.D with 3-5 years experience in Pharma/Biotech industry.
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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.
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Knowledge of current International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, GMP guidelines, and related industry practices.
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Working experience and knowledge of regulatory submission (Investigational New Drug (IND), Investigational Medicinal Product Dossier (IMPD), and / or New Drug Application (NDA).
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Demonstrated experience working in cross-fuctional teams and effective communication across multiple functional areas.
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Effective written and verbal communication skills and interpersonal skills.
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Ability to interpret complex project information and identification of potential timeline and project risks.
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.
