The Opportunity:

We are seeking a strategic, collaborative, and execution-oriented leader for the role of Senior Director, Global CMC Lead. The Senior Director, Global CMC Lead will provide cross-functional leadership and accountability for defining and executing integrated CMC strategies across development-stage and late-stage small molecule programs. This individual will partner closely with CMC cross functional teams, Regulatory, Quality, Clinical Development, and external partners to advance programs efficiently from development through commercialization readiness.

The ideal candidate will bring deep expertise in small molecule pharmaceutical development and manufacturing, a strong understanding of the oncology drug development lifecycle, and the ability to thrive in a dynamic, fast-paced, and highly collaborative environment.

Responsibilities:

• Lead and execute integrated global CMC strategies across assigned development programs from early development through commercialization readiness.
• Serve as the primary CMC lead on cross-functional program teams, accountable for CMC timelines, deliverables, risks, and strategic alignment.
• Drive CMC planning and execution for global regulatory submissions, including INDs, CTAs, NDAs/MAAs, and lifecycle management activities.
• Anticipate, assess, and proactively mitigate CMC risks impacting development timelines, regulatory success, product quality, or supply continuity.
• Provide strategic oversight of drug substance and drug product development, manufacturing, analytical development, specifications, and control strategies.
• Partner closely with PDM functional teams and external CDMOs to ensure technical readiness for late-stage development, PPQ, validation, commercial supply, launch readiness, and lifecycle management activities.
• Support supply planning, capacity management, dual sourcing strategies, and risk mitigation initiatives to ensure robust and reliable supply continuity.
• Ensure all CMC activities are conducted in compliance with applicable GMP, ICH, FDA, EMA, and other global regulatory requirements.
• Collaborate closely with PDM functional leaders to define and execute global CMC regulatory strategies and support health authority interactions.
• Act as a strategic partner to Clinical Development, Regulatory, Nonclinical, and Commercial organizations.
• Communicate CMC risks, trade-offs, timelines, investment needs, and program status clearly to senior and executive leadership.
• Support business development activities, including CMC due diligence evaluations and integration planning as needed.

Required Skills, Experience and Education:

• PhD (strongly preferred), MS, or equivalent degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline.
• 12+ years of progressive CMC experience within the pharmaceutical or biotechnology industry, with significant experience supporting small molecule development programs.
• Demonstrated leadership of CMC activities across multiple stages of development, including late-stage development and commercialization readiness.
• Proven experience supporting global regulatory submissions and interactions with major health authorities, including FDA, EMA, and PMDA.
• Deep technical expertise in small molecule API and drug product development, manufacturing, analytical development, and control strategies.
• Strong understanding of external manufacturing models, CDMO oversight, and cross-functional collaboration in matrixed environments.
• Broad knowledge of global CMC regulatory requirements, GMP expectations, and lifecycle management principles.
• Strategic, enterprise-minded leader with strong decision-making, problem-solving, and risk management capabilities.
• Demonstrated ability to lead through influence and drive alignment across highly collaborative, matrixed organizations.
• Strong scientific and regulatory judgment, with clear and effective communication skills.
• Ability to thrive in a fast-paced, highly collaborative, and data-driven environment.

Preferred Skills:

• Experience in oncology drug development, particularly targeted therapies.
• Experience supporting accelerated development timelines and/or first-in-class programs.
• Experience supporting commercial launch activities and post-approval lifecycle management.
• Experience with late-stage development activities, including validation and commercial manufacturing readiness.
  #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.

Base Pay Salary Range

$244,000-$305,000 USD

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.

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 [email protected] so we can share these impersonations with our IT team for tracking and awareness.