Executive Director, Global CMC Lead
ExecutiveManufacturingOncologySmall Molecule
From $265K/yr(estimated)
Description
<p>Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.&nbsp; The company’s R&amp;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&nbsp;in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.</p>
<p><strong>The Opportunity:</strong></p>
<p>We are seeking an accomplished, strategic and execution-oriented leaders, Executive Director, Global CMC Lead, reporting to SVP of Pharmaceutical Development and Manufacturing (PDM).&nbsp; The Executive Director, Global CMC Lead provides enterprise-level leadership and accountability for defining and executing the global CMC strategy across the development and commercialization lifecycle. This role sets technical and regulatory direction for late stage and commercial programs, ensures supply continuity, and partners closely with Development, Regulatory, Quality, and Commercial leadership to enable rapid, compliant, and scalable product advancement globally.&nbsp;&nbsp; The role combines deep technical credibility in small molecule development with strong strategic judgment, people leadership, and external influence.&nbsp; The role requires expertise in small molecule pharmaceutical development and manufacturing, an understanding of the oncology development lifecycle, and the ability to thrive in a dynamic, fast-paced environment.</p>
<p>Responsibilities<strong>:</strong></p>
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<p>Own the integrated global CMC strategy across assigned development and commercial programs</p>
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<p>Serve as the senior CMC leader on program and portfolio teams, accountable for CMC timelines, risks, and deliverables.</p>
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<p>Drive clear, risk-based CMC decision-making that balances speed, quality, and long-term product robustness.</p>
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<p>Anticipate and proactively manage CMC risks impacting development speed, regulatory success, or supply robustness.</p>
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<p>Provide strategic oversight of drug substance development and manufacturing, drug product development and manufacturing, specification and control strategy development, and lifecycle optimization.</p>
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<p>Partner with PDM cross-functional team / leadership to ensure technical readiness for late-stage development, PPQ, validation, and commercial supply, capacity planning, risk mitigation, dual sourcing as needed, and launch readiness, as well as life cycle development.</p>
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<p>Partner with PDM cross-functional team / leadership to define global CMC regulatory strategy for IND/CTA, NDA/MAA, JNDA and post-approval lifecycle activities.</p>
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<p>Provide senior-level review and approval of CMC content for global submissions and health authority interactions.</p>
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<p>Ensure all CMC activities meet global GMP, ICH, and regulatory expectations.</p>
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<p>Act as a strategic partner to Clinical Development, Regulatory, Quality, Nonclinical, and Commercial leadership.</p>
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<p>Clearly communicate CMC risks, trade-offs, timelines, and investment needs to executive leadership.</p>
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<p>Support business development due diligence and integration from a CMC perspective.</p>
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<p><strong>Required Skills, Experience and Education:</strong></p>
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<p>PhD (strongly preferred), MS, or equivalent in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline.</p>
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<p>15+ years of progressive CMC experience in the pharmaceutical or biotechnology industry, with a strong focus on small molecules.</p>
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<p>Demonstrated leadership of CMC activities from early development through commercialization life cycle.</p>
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<p>Proven experience leading global regulatory submissions and interacting with major health authorities (FDA, EMA, PMDA).</p>
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<p>Deep expertise in small molecule API and drug product development, manufacturing, and control strategies.</p>
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<p>Strong understanding of external manufacturing models and CDMO governance.</p>
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<p>Broad knowledge of global CMC regulatory requirements and lifecycle management.</p>
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<p>Strategic, enterprise-minded leader with strong decision-making and risk management capabilities.</p>
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<p>Proven ability to lead through influence in highly matrixed environments.</p>
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<p>Clear, decisive leadership style with strong scientific and regulatory judgment.</p>
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<p>Ability to operate effectively in a fast-paced, highly collaborative, and data-driven environment.</p>
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<p><strong>Preferred Skills:</strong></p>
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<p>Oncology drug development, particularly targeted therapies.</p>
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<p>Experience supporting accelerated development timelines and first-in-class programs.</p>
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<p>Experience with commercial launch and post-approval lifecycle management.&nbsp;</p>
<p class="p1"><span style="color: rgb(255, 255, 255);">#LI-Hybrid&nbsp; #LI-GL1</span></p>
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</ul><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>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.</p>
<p>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.</p>
<p>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.</p>
<p>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&nbsp;<a href="https://www.revmed.com/ccpa-notice">CCPA Notice</a>&nbsp;and&nbsp;<a href="https://www.revmed.com/privacy-policy">Privacy Policy</a>.&nbsp;For additional information, please contact&nbsp;<a href="mailto:privacy@revmed.com">privacy@revmed.com</a>.</p></div><div class="title">Base Pay Salary Range</div><div class="pay-range"><span>$265,000</span><span class="divider">&mdash;</span><span>$331,000 USD</span></div></div></div><div class="content-conclusion"><hr>
<p><em>We 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.</em><br><em>&nbsp;</em><br><em>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 <strong>@revmed.com</strong> email address.</em><br><em>&nbsp;</em><br><em>If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to <span style="color: rgb(35, 111, 161);"><strong>careers@revmed.com</strong></span> so we can share these impersonations with our IT team for tracking and awareness.</em></p>
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<p>&nbsp;</p></div>
REVOLUTION Medicines
BIOTECHNOLOGY
Small Molecules
LocationREDWOOD CITY, CA
Open Jobs268
OncologyNeurologyGastroenterologyRespiratory
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