- Job Type: Full-Time
- Function: Product Mangement
- Industry: Biotechnology
- Post Date: 11/10/2024
- Website: www.revmed.com
- Company Address: 700 Saginaw Dr, Redwood City, California 94063, US
About Revolution Medicines
REVOLUTION Medicines discovers and develops new drugs that harness the therapeutic potential of frontier oncology targets on behalf of cancer patients.Job Description
Revolution Medicines (RevMed) 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.
Required Skills, Experience and Education:
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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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Enable CMC leads and/ or functional leads in implementing comprehensive CMC strategies and development plans and driving the CMC timelines to meet projects ‘needs.
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Develop, Maintain, and track CMC timelines, deliverables and other relevant documents.
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Collaborate with team members in CMC, QA, and Regulatory Affairs, to execute the CMC projects according to established CMC development 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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Collaborating 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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Support and facilitate the CMC portfolio review process to support the growing pipeline.
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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 Harmonization 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-functional 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.
Preferred Skills:
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Small molecule development experience.
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B.S. or M.S. or Ph.D. degree in Pharmaceutics, Chemistry, Chemical engineering or closely related field.
The base salary range for this full-time position is $135,000 to $175,000 for candidates based at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the minimum and maximum salary for the position in Redwood City and will be adjusted for the local market a candidate is based. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that 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 our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.