Senior Manager, CMC Project Management
1 day ago
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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The OpportunityRevolution 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-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 Associate Director, CMC Project Management.
Responsibilities- Provide project management support to CMC teams for projects ranging from Pre-IND through different phases of clinical development and commercialization.
- Track CMC timelines, deliverables and other relevant documents.
- Collaborate with team members in PDM, QA, clinical and non-clinical development teams to ensure project activities are progressing within established timelines
- 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.
- S with 10+ years/M.S with 5-8 years/Ph.D with 3-5 years experience in Pharma/Biotech industry.
- 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 identification of potential timeline and project risks.
- Small molecule development experience.
- S. or M.S. or Ph.D. degree in Pharmaceutics, Chemistry, Chemical engineering or closely related field is desirable.
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