Senior Manager, CMC Project Management

Posted Yesterday
Be an Early Applicant
Redwood City, CA, USA
Hybrid
164K-205K Annually
Senior level
Healthtech • Biotech
The Role
Manages cross-functional CMC project activities supporting pharmaceutical development, clinical programs, and commercialization from Pre-IND through later development phases. Tracks timelines, deliverables, regulatory filing milestones, risks, meetings, and action items; coordinates with PDM, QA, clinical, nonclinical, and Regulatory Affairs teams; and oversees outsourced development activities with CDMOs.
Summary Generated by Built In

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.

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 [email protected].

Base Pay Salary Range
$164,000$205,000 USD

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 [email protected] so we can share these impersonations with our IT team for tracking and awareness.


Skills Required

  • B.S. degree with 10+ years, M.S. degree with 5–8 years, or Ph.D. degree with 3–5 years of experience in the pharmaceutical or biotechnology industry
  • Strong CMC project management experience across various phases of pharmaceutical development
  • Understanding of the drug development cycle
  • Knowledge of current ICH guidelines, GMP guidelines, and related industry practices
  • Working experience and knowledge of IND, IMPD, and/or NDA regulatory submissions
  • Experience working in cross-functional teams and communicating across multiple functional areas
  • Effective written, verbal, and interpersonal communication skills
  • Ability to interpret complex project information and identify timeline and project risks
  • Regulatory filing experience
  • Small molecule development experience
  • Degree in Pharmaceutics, Chemistry, Chemical Engineering, or a closely related field
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The Company
HQ: Redwood City, California
548 Employees
Year Founded: 2014

What We Do

We are Revolutionaries – passionate in our singular pursuit of discovering, developing and delivering innovative, targeted medicines for patients living with cancer. To deliver on our vision, we work relentlessly in pursuit of cutting-edge therapeutic approaches to some of the toughest cancers. Our current focus is on RAS-addicted cancers, which account for 30 percent of all new human cancer diagnoses

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