REVOLUTION Medicines
Director, Analytical Development
REVOLUTION Medicines, Redwood City, California, United States, 94061
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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Playing a critical role as the analytical development technical lead, the position will be responsible for analytical development activities leading to NDA submission and commercialization, as well as development and execution of the CMC strategy. The individual will provide technical and project leadership, and work with cross-functional stakeholders to ensure analytical development and CMC activities are executed seamlessly and in alignment with the integrated CMC development plan and program timelines.
Lead the development and implementation of analytical strategies to advance new chemical entities (NCE) from preclinical lead optimization stage through commercialization. Drive analytical method development, optimization, validation, and troubleshooting, and characterization activities for both drug substances (DS) and drug products (DP). Develop and oversee quality control strategies, including quality risk management, specifications development, analytical package for DS and DP registration, validation, and commercial readiness. Author and review technical documents, analytical sections of regulatory documents (INDs, IMPDs, NDAs, MAAs, J-NDA, etc.), and responses to regulatory agencies. Stay current with emerging analytical technologies and regulatory trends, drive innovation and continuous improvement across analytical workflows. Build, mentor, and lead a high-performing analytical development team, foster a culture of scientific excellence, collaboration, and accountability both internally and with external partners. Collaborate cross-functionally with teams in drug substance, drug product, supply chain, quality, regulatory, clinical pharmacology, and toxicology to ensure alignment and execution of CMC and program objectives. Required Skills, Experience and Education:
PhD in Chemistry, Pharmaceutical Sciences, or related discipline with 12+ years of industry experience; or MS with 15+ years. Deep expertise in small molecule analytical method development and characterization in the pharmaceutical/biotech industry. Proven track record of leading analytical development through all phases of drug development, including NDA/MAA submissions. Strong knowledge of GMP regulations, quality systems, ICH guidelines, and regulatory expectations (FDA, EMA, etc.) Extensive experience managing CROs and working in a virtual development model. Excellent leadership, people/team management, project management, and cross-functional collaboration skills. Strong problem-solving skills with strategic and technically sound decision-making ability. Excellent written and verbal communication skills and interpersonal skills. Energetic, team-oriented, and adaptable to a fast-paced, dynamic environment. Preferred Skills:
Experience with small molecule oncology drug development. #LI-Hybrid #LI-CT1
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 privacy@revmed.com.
Base Pay Salary Range
$204,000-$255,000 USD
The Opportunity:
Playing a critical role as the analytical development technical lead, the position will be responsible for analytical development activities leading to NDA submission and commercialization, as well as development and execution of the CMC strategy. The individual will provide technical and project leadership, and work with cross-functional stakeholders to ensure analytical development and CMC activities are executed seamlessly and in alignment with the integrated CMC development plan and program timelines.
Lead the development and implementation of analytical strategies to advance new chemical entities (NCE) from preclinical lead optimization stage through commercialization. Drive analytical method development, optimization, validation, and troubleshooting, and characterization activities for both drug substances (DS) and drug products (DP). Develop and oversee quality control strategies, including quality risk management, specifications development, analytical package for DS and DP registration, validation, and commercial readiness. Author and review technical documents, analytical sections of regulatory documents (INDs, IMPDs, NDAs, MAAs, J-NDA, etc.), and responses to regulatory agencies. Stay current with emerging analytical technologies and regulatory trends, drive innovation and continuous improvement across analytical workflows. Build, mentor, and lead a high-performing analytical development team, foster a culture of scientific excellence, collaboration, and accountability both internally and with external partners. Collaborate cross-functionally with teams in drug substance, drug product, supply chain, quality, regulatory, clinical pharmacology, and toxicology to ensure alignment and execution of CMC and program objectives. Required Skills, Experience and Education:
PhD in Chemistry, Pharmaceutical Sciences, or related discipline with 12+ years of industry experience; or MS with 15+ years. Deep expertise in small molecule analytical method development and characterization in the pharmaceutical/biotech industry. Proven track record of leading analytical development through all phases of drug development, including NDA/MAA submissions. Strong knowledge of GMP regulations, quality systems, ICH guidelines, and regulatory expectations (FDA, EMA, etc.) Extensive experience managing CROs and working in a virtual development model. Excellent leadership, people/team management, project management, and cross-functional collaboration skills. Strong problem-solving skills with strategic and technically sound decision-making ability. Excellent written and verbal communication skills and interpersonal skills. Energetic, team-oriented, and adaptable to a fast-paced, dynamic environment. Preferred Skills:
Experience with small molecule oncology drug development. #LI-Hybrid #LI-CT1
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 privacy@revmed.com.
Base Pay Salary Range
$204,000-$255,000 USD