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Senior Director/Vice President, Pharmaceutical Development - CMC

Revolution Medicines

Redwood City, CA, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Industry: Biotechnology
  • Post Date: 11/22/2022
  • Website: www.revmed.com
  • Company Address: 700 Saginaw Drive, Redwood City, CA, 94063

About Revolution Medicines

REVOLUTION Medicines discovers and develops new drugs that harness the therapeutic potential of frontier oncology targets on behalf of cancer patients. Our innovative product engine draws inspiration from nature and evolution, which offer insights into cancer targets, disease mechanisms and therapeutic approaches.

Job Description

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value 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.

Playing a senior leadership role within the CMC function, the position will be accountable for formulation development and drug product manufacturing operations in support of clinical development and commercialization of the RevMed pipeline compounds.   The individual will provide technical, organizational, and strategic leadership, and work closely with cross-functional stakeholders to ensure drug product development and manufacturing activities are executed seamlessly and in alignment with the integrated product development plan and program timelines.  The individual will also play a critical role in, and participate in, the overall CMC strategy planning and execution.    

The Opportunity:

  • Lead formulation development and drug product manufacturing operations from early to late development through commercialization.

  • Be responsible for developing strategies, overseeing execution of functional activities associated with formulation development and drug product manufacturing 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.

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

  • Collaborate with cross-functional teams (process R&D, analytical development, supply chain, quality, clinical, regulatory, 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 drug product development and manufacturing with adequate risk assessment.

  • Travel to CDMOs for vendor assessment and qualification, as well as manufacturing oversight as needed.

 Required Experience, Skills, and Education: 

  • Preferably a Ph.D. (minimum MSc degree) in Pharmaceutics, Chemistry, Chemical Engineering, or a closely related field is desirable.

  • 18 + years of experience in the pharmaceutical/biotech industry with a sound track record of technical expertise and organizational leadership, early and late phase formulation development, and drug product manufacturing experience of small molecules.

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

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

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

  • Thorough understanding and working experience in drug product 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 manufacturing activities at CDMOs.

  • 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.

Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company’s offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law.

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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