Senior Manager, CMC Project Management

Revolution Medicines, Inc.; Redwood City (CA); On-site; USD 164,000 - 205,000; Full time

Job summary

Revolution Medicines is seeking a motivated individual with a scientific background and project management experience to join the CMC Project Management team within the PDM function (Pharmaceutical Development and Manufacturing).

This role is responsible for managing cross-functional CMC project management activities in support of Revolution Medicines’ pipeline compound development and clinical programs, reporting to the Associate Director, CMC Project Management.

Qualifications

• BS with 10+ years/MSc 5-8 years/PhD 3-5 years in pharma/biotech.
• Strong CMC project management experience across development phases.
• Knowledge of ICH guidelines, GMP and related industry practices.
• Experience with regulatory submissions (IND, IMPD, NDA).
• Experience working in cross-functional teams and strong communication.

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.

Skills

CMC project management

Regulatory filings experience

ICH GMP guidelines

Cross-functional collaboration

Regulatory submissions

Education

Pharma/Biotech degree (BS/MS/PhD)

Job description

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.

The Opportunity:

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.

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.

Required Skills, Experience and Education:

• B.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-fuctional 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.

Preferred Skills:

• Small molecule development experience.

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

#LI-CT1 #LI-Hybrid

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range 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.

Base Pay Salary Range

$164,000—$205,000 USD

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.

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