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Vice President, Analytical Development & QC

Revolution Medicines

Redwood City, CA, US
  • Job Type: Full-Time
  • Function: Life Sciences R&D/Engineering
  • Industry: Biotechnology
  • Post Date: 07/08/2024
  • 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 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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

Playing a senior leadership role within Pharmaceutical Development and Manufacturing (PDM) organization, the position will be accountable for analytical development and operations in support of clinical development and commercialization of the Revolution Medicines pipeline compounds. The individual will provide technical, organizational and strategic leadership, and work closely with cross-functional stakeholders to ensure end-to-end drug development and manufacturing activities are executed seamlessly and in alignment with the integrated development plan and program timelines. The individual will also play a critical role in, and participate in, the overall CMC strategy planning and execution.

  • Lead analytical development and operations from early to late development through commercialization

  • Be accountable for analytical related development strategies, overseeing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals and commercialization

  • Author/review/approve the relevant CMC sections to enable global regulatory filings

  • Lead cross-functional CMC team for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed

  • Serve as a project core team member and communicate CMC strategy and project status to the key stakeholder cross-functionally and assist in driving decision-making

  • Collaborate with cross functional teams (drug substance, drug product, supply chain, quality, CMC regulatory, CMC PM, Clinical, DMPK and tox, as well as program management) to ensure CMC and program goals are met

  • Lead the efforts to assess / identify potential suppliers for analytical development and QC activities in support of drug substance and drug product development and manufacturing with adequate risk assessment

  • Travel to CDMOs and/or CTLs for the vendor assessment and qualification, as well as analytical activities oversight as needed

Required Skills, Experience and Education:

  • Minimum MSc degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field

  • 18 + years of experience in the pharmaceutical/biotech industry with a sound track record of technical expertise and organizational leadership, early and late phase analytical development and operations experience of small molecules with commercial experience a plus

  • Extensive experience in late phase innovative drug development and commercial launch with global CMC regulatory filings (IND/NDA/MAA, etc.)

  • Proven track record of strategic leadership and management with at least 10 years on the management role

  • Demonstrated strong project and cross-functional team leadership, as well as people management skills

  • Thorough understanding and working experience of innovative drug development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA and associated regulatory requirements

  • Extensive working experience with management and oversight of the analytical activities at CDMOs and/or CTLs

  • Strong problem-solving skills with strategic and sound technically driven decision-making ability

  • Effective written and verbal communication skills and interpersonal skills

  • Innovative team-player with high energy for our dynamic company environment

Preferred Skills, Experience and Education:

  • Preferably a PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field is desirable.

The expected salary range for this role is $265,000 to $350,000. An individual’s position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. Base salary is one part of the overall total rewards program at Revolution Medicines, 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.

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