Director, Pharmaceutical Development

Company: THIRD ROCK VENTURES, LLC
Location: Redwood City
Posted on: March 20, 2023

Job Description:

Director, Pharmaceutical Development at Revolution Medicines 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 scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. Playing a critical role as the drug product technical lead and CMC project lead, the position will be responsible for drug product development activities leading to NDA submission and commercialization, as well as the development and execution of the CMC strategy. The individual will provide technical and project leadership, and work with cross-functional stakeholders to ensure pharmaceutical drug product development and CMC activities are executed seamlessly and in alignment with the integrated product development plan and program timelines. The Opportunity: Lead drug product development activities from early to late development through commercialization. Lead drug product technical transfer, process development, optimization, qualification, and validation of activities related to all manufacturing operations. Design and oversee the execution of QbD and risk-based studies, as well as process development activities in preparation for registration, validation, and commercialization activities. Be responsible for the development of strategies, overseeing the execution of technical activities associated with product development and manufacturing in support of clinical development, regulatory filings (IND/NDA/MAA), and product approvals and commercialization. Author/review 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) to ensure CMC and program goals are met. 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 leadership, early and late phase drug product development experience of small molecules. Demonstrated strong project and cross-functional team leadership, as well as people management Thorough understanding and working experience of the pharmaceutical drug product with respect to GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements. Extensive experience in late-phase drug product development and commercial development with CMC regulatory filings for US (NDA), Europe (MAA), Japan, and China. Strong problem-solving skills with strategic and sound technically driven decision-making ability. Excellent 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. The expected salary range for this role is $195,000 to $245,000. 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 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 ourCCPA Notice andPrivacy Policy .For additional information, please contactprivacy@revmed.com . 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 ourCCPA Notice andPrivacy Policy .For additional information, please contactprivacy@revmed.com .

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