Director, Drug Substance
$211k - $264kRevolution Medicines
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:Playing a critical role as a technical lead within the Drug Substance function, the position will be responsible for process research and development and scale-up of manufacturing in support of Revolution Medicines’ pipeline compound development, clinical programs and commercial readiness. Responsibilities:Responsible for developing chemical processes for the manufacture of drug substance, intermediates and/or starting materials, including route evaluation and process optimization.Conduct process development and optimization studies according to the principles of quality by design (QbD), to enable regulatory starting materials designation, establish control strategy and process characterization studies using tools such as design of experiment (DOE) studies.Lead and/or enable technology transfer, process familiarization, and manufacturing at CDMOs.Participate in identification, selection, and management of CROs and CDMOs including management of redundant supply and geographic diversity.Write, review, and approve protocols, manufacturing batch records, and development and campaign reports.Author, review the relevant CMC sections of regulatory filings and patent applications.Partner with analytical development, pharmaceutical development, and supply chain functions to design overall strategy for programs.Communicate effectively within cross functional project teams.Travel to CRO/CDMO for the oversight of development activities and manufacturing (up to approximately 15%).Required Skills, Experience and Education:PhD (minimum MSc degree) in organic chemistry, chemical engineering or related discipline.10 or more years (15+ years for Master’s degree) of relevant industrial experience in chemical / drug substance process research and development.Strong people management skills.Hands-on proficiency in synthetic organic chemistry.Knowledge of current ICH guidelines, GMP, and relevant industry practices.Working experience and knowledge of regulatory submissions (IND, IMPD, NDA and MAA).Previous experience managing projects at CROs/CDMOs.Strong problem solving skills with sound technically driven decision-making ability.Effective written and verbal communication skills and interpersonal skills.An innovative team-player with high energy for our dynamic company environment. #LI-Hybrid #LI-CT1The 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 View email address on click.appcast.io Pay Salary Range$211,000—$264,000 USDWe 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 View email address on click.appcast.io so we can share these impersonations with our IT team for tracking and awareness.
$210k - $245k
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...discipline (e.g. Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices). Minimum 10 years of experience... ..., EMA, Health Canada and ICH) guidelinesReports to: Executive Director, CMC RegulatoryLocation: San Carlos, CA / US RemoteWork...$177k - $221k
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...regulatory requirements. Responsibilities Author, co-author, critically edit, and format clinical/regulatory documents, including New Drug Applications (NDAs), protocols/protocol amendments, clinical study reports (CSRs), Investigator’s Brochures, and other regulatory...Full timeFor contractors$211k - $264k
...identify and characterize high-priority oncology targets for our tri-complex inhibitor (TCI) platform. We are looking for an experienced drug hunter to lead the Target Biology team, provide hands-on scientific and people leadership, and work cross-functionally to identify...Full timeLocal area- ...right treatments for the right patients, at the right time.The Director of Epidemiology & Methodological Innovation will lead high-impact... ...non-linear data into regulatory-grade insights that accelerate drug development and improve patient outcomes.Key ResponsibilitiesMethodological...Full timeRemote work
$244k - $305k
...informed development decisions and global regulatory filings. The successful candidate will:Lead nonclinical safety strategy for multiple drug development programs spanning both small molecules and biologics.Serve as the toxicology representative on cross-functional Research...Full timeLocal areaWorldwide$211k - $264k
...presentation.Contribute to the development of functional-level standards, SOPs, and templates.Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members.Required Skills,...Full timeLocal area$186k - $233k
...mutations in the RAS signaling pathway.The Opportunity:The Associate Director, Global Regulatory Affairs Project Management is an integral... ...to guide cross-functional teams, supporting planned and ongoing drug marketing applications across RevMed programs. The role partners...Full timeWork at officeLocal area$184.5k - $230k
...was granted Fast Track designation by the United States Food & Drug Administration (FDA) for the HARMONi clinical trial setting.... ...interviewing at Summit Therapeutics, Inc. by 2x. Seniority Level Director Employment Type Full‑time Job Function Strategy/...Full timeInterim roleWork at office$229.3k - $269.8k
...City, California. To learn more, visit As an Associate Medical Director, you will support the ongoing and planned execution of the Oncology... ..., develop and, implement clinical studies for the applicable drug candidate, from Phase I through Phase III Develop and participate...Full time$211k - $264k
...to play a critical role as the supplier management lead for drug substance within the Pharmaceutical Development and Manufacturing (PDM)... ...team leadership responsibilities, reporting into the Senior Director, Head, Supplier Management, Operations & Portfolio Management...Full timeLocal areaWorldwide$167k - $208.75k
Location: Hybrid in San Carlos, CA preferred but US Remote is consideredPosition OverviewWe are seeking a highly experienced Associate Director, CDx Partnership Program Management with a proven track record across a substantial portfolio of CDx pharmaceutical partnerships,...Immediate startRemote workWorldwide$175k - $225k
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...act with urgency and hold ourselves to a high standard of rigor-all in service of patients. The Opportunity: The Associate Director, Business Operations is an internal project manager with a consultant mindset and hands-on approach. This is an execution-focused...Full timeLocal areaWorldwide$186k - $233k
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company...Full timeLocal area$186k - $233k
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...headquartered in Redwood City, California. To learn more, visit As a member of the Statistical Programming team, the Associate Director is responsible for the planning, execution, and quality of SAS programming to conduct statistical analyses in support of clinical...Full time
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