Sobre este puesto de Senior Director, Analytical Development en Revolution 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:
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Playing a critical role as the analytical development technical lead, the position will be responsible for analytical development activities, 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.
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Lead the development and implementation of analytical strategies to advance new chemical entities (NCE) from preclinical lead optimization stage through commercialization.
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Drive analytical method development, optimization, validation, and troubleshooting, and characterization activities for both drug substances (DS) and drug products (DP).
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Develop and oversee specifications development, analytical package for DS and DP registration, validation, and commercial readiness.
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Author and review technical documents, analytical sections of regulatory documents (INDs, IMPDs, NDAs, MAAs, J-NDA, etc.), and responses to regulatory agencies.
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Stay current with emerging analytical technologies and regulatory trends, drive innovation and continuous improvement across analytical workflows.
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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.
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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:
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PhD in Chemistry, Pharmaceutical Sciences, or related discipline with 18+ years of industry experience; or MS with 20+ years.
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Deep expertise in small molecule analytical method development and characterization in the pharmaceutical/biotech industry.
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Proven track record of leading analytical development through all phases of drug development, including NDA/MAA submissions.
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Strong knowledge of GMP regulations, quality systems, ICH guidelines, and regulatory expectations (FDA, EMA, etc.)
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Extensive experience managing CROs and working in a virtual development model.
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Excellent leadership, project management, and cross-functional collaboration skills.
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Strong problem-solving skills with strategic and technically sound decision-making ability.
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Excellent written and verbal communication skills and interpersonal skills.
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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.
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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.
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