Executive Director, Analytical Development & Quality Control

Revolution Medicines; Redwood City (CA); On-site; USD 265,000 - 331,000; Full time

Job summary

Revolution Medicines seeks an accomplished leader to drive Analytical Development & Quality Control across its growing oncology portfolio. You will shape long‑term analytical strategy and build scalable capabilities, partnering with external networks to accelerate development while ensuring regulatory compliance.

The role demands extensive GMP and regulatory experience, and a track record of leading large teams in late‑stage programs.

Qualifications

• PhD in Analytical Chemistry or related field.
• ~18+ years of industry experience with leadership in analytical development and QC.
• Proven track record supporting late-stage development and global regulatory filings (IND/NDA/MAA/JNDA).
• Demonstrated success leading and scaling teams (10+ years in leadership roles preferred).
• Deep expertise in GMP, quality systems, and global regulatory expectations (FDA, EMA, ICH).
• Extensive experience managing external analytical networks (CDMOs, CTLs).
• Strong strategic thinking with data-driven, risk-balanced decisions.
• Excellent communication and stakeholder influence at executive levels.

Responsibilities

• Provide enterprise leadership for analytical development, QC, and CMC analytical strategy across the oncology portfolio.
• Define phase-appropriate analytical control strategies for quality, regulatory compliance and tech transfer.
• Lead external partnerships with CDMOs, CROs, and labs; establish governance and performance metrics.
• Support global regulatory submissions (INDs, NDAs, MAAs, JNDA) and regulatory interactions.
• Drive innovation through advanced analytics, lab digitalization and data-driven approaches.

Skills

Executive leadership

Strategic thinking

Stakeholder management

Communication skills

Regulatory knowledge

Education

PhD in Analytical Chemistry

MSc in Pharmaceutical Sciences

Job description

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’s RAS(ON) inhibitors daraxonrasib (RMC‑6236), a RAS(ON) multi‑selective inhibitor; elironrasib (RMC‑6291), a RAS(ON) G12C‑selective inhibitor; zoldonrasib (RMC‑9805), a RAS(ON) G12D‑selective inhibitor; and RMC‑5127, a RAS(ON) G12V‑selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity

We are seeking an accomplished and visionary Executive Director, Analytical Development & Quality Control (ADQC) to provide enterprise leadership for analytical development, quality control, and CMC analytical strategy across our expanding oncology portfolio.

As a member of the Pharmaceutical Development & Manufacturing (PDM) Extended Leadership Team and the ADQC Leadership Team, this executive will define the long‑term analytical vision, build organizational capabilities, and establish scalable analytical and quality control strategies that enable rapid development while supporting late‑stage development and commercialization.

Responsibilities

Technical, Strategic and Organization Partnerships

• Serve as a key member of the Pharmaceutical Development & Manufacturing (PDM) Extended Leadership Team, influencing enterprise CMC strategy, portfolio prioritization, and cross‑functional business decisions.
• Define and execute the enterprise analytical development and quality control strategy aligned with corporate objectives, portfolio priorities, and commercialization goals.
• Provide scientific and strategic leadership for analytical development across the product lifecycle, including analytical characterization, specification development, impurity profiling, stability, comparability, and analytical method lifecycle management.
• Establish phase‑appropriate analytical control strategies that ensure product quality, process understanding, regulatory compliance, and successful technology transfer from early development through commercialization.
• Partner cross‑functionally to ensure analytical strategies support accelerated development while maintaining scientific rigor, regulatory compliance, and commercial readiness.
• Provide executive analytical leadership for global regulatory submissions, including INDs, IMPDs, NDAs, MAAs, JNDAs, and other international filings, and represent the company during health authority interactions, inspections, and regulatory meetings.
• Champion innovation through implementation of advanced analytical technologies, laboratory digitalization, automation, and data‑driven approaches.
• Build organizational capability by fostering scientific excellence, innovation, continuous improvement, accountability, collaboration, and inclusion across the ADQC organization.
• Foster strategic scientific collaborations with external experts, industry consortia, and technology partners while leveraging emerging analytical technologies and best practices.

External Partnerships

• Define and execute the enterprise strategy for a high‑performing global network of CDMOs, CROs, and contract testing laboratories.
• Build strategic partnerships that enhance technical capabilities, operational scalability, business continuity, and commercialization readiness.
• Provide executive oversight of outsourced analytical development, analytical method validation, technology transfer, and lifecycle management across the external network.
• Establish governance models, performance metrics, and executive business review processes to ensure operational excellence, quality, regulatory compliance, and continuous improvement.
• Develop long‑term strategic partnerships that expand analytical capabilities, improve organizational agility, and support commercialization needs.
• Collaborate with external partners to drive innovation and accelerate product development while maintaining scientific excellence and compliance.

Required Skills, Experience and Education

• PhD (preferred) or MSc in Analytical Chemistry, Pharmaceutical Sciences, or related field.
• ~18+ years of industry experience with significant leadership in analytical development and QC.
• Proven track record supporting late‑stage development and global regulatory filings (IND/NDA/MAA/JNDA).
• Demonstrated success leading and scaling teams (10+ years in leadership roles preferred).
• Deep expertise in GMP, quality systems, and global regulatory expectations (FDA, EMA, ICH).
• Extensive experience managing external analytical networks (CDMOs, CTLs).
• Strong strategic thinking with the ability to make data‑driven, risk‑balanced decisions.
• Excellent communication and stakeholder influence at executive levels.

Preferred Skills

• Experience in oncology or targeted therapies.
• Background in accelerated or expedited development pathways.
• Experience building analytical/QC functions in a high‑growth biotech environment.
• Ability to balance speed, quality, and risk in a dynamic setting.

Base pay salary range: $265,000 – $331,000 USD.

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.

If you have questions, please contact [e-mail].