Executive Director - Multiple Teams
$265k - $331k+ Equity awards
Expert
Master's, PhD
Redwood City, CA, USA
HybridOnsite at the Redwood City headquarters; occasional travel up to 15% may be required.
Biology & BiotechRegulatory & Quality (Life Sciences)
About the job
Requirements
- An advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred).
- At least 15 years of experience in the pharmaceutical or biotechnology industry, including at least 10 years in GCP QA or clinical quality leadership roles, with demonstrated experience leading and hosting regulatory inspections such as FDA BIMO, EMA, MHRA, and PMDA.
- Demonstrated experience interacting directly with global health authorities and leading inspection strategy and execution.
- Experience supporting late-stage clinical development and regulatory submissions such as NDA and MAA, preferably in oncology.
- A proven track record and relevant industry experience leading GCP QA functions within a global organization, preferably in oncology.
- Strong knowledge of global GCP regulations, ICH guidelines, and clinical trial processes.
- Experience working within outsourced clinical trial models and managing global CRO/vendor networks is highly desirable.
- Excellent leadership, communication, team building, and people skills, with the ability to influence stakeholders at all levels.
- Analytical thinking focused on continuous improvement and innovation.
- Flexibility to work in a fast-paced, dynamic environment with evolving priorities.
- Occasional travel of up to 15% may be required for audits, inspections, and meetings.
Responsibilities
- Develop and execute the global GCP QA strategy aligned with corporate objectives, regulatory requirements, and company SOPs.
- Serve as the Clinical QA Lead for global Phase 2/3 oncology studies, representing QA in governance forums and providing decision-making oversight on GCP-related matters.
- Establish and maintain GCP QA frameworks, including policies, procedures, systems, and risk-based quality management, to ensure compliance with global regulations including FDA, EMA, and ICH.
- Provide end-to-end QA oversight of clinical studies, including reviewing and approving key study documents such as protocols, monitoring plans, vendor oversight plans, and quality agreements; ensuring Trial Master File quality and inspection readiness; and overseeing GxP computerized systems and data integrity controls.
- Lead and oversee GCP audit and inspection activities, including investigator sites, vendors, internal processes, and regulatory inspections such as BIMO and PV, ensuring timely resolution of findings and CAPAs.
- Serve as the primary QA interface with global regulatory authorities, lead inspection strategy, and represent the organization during health authority interactions.
- Drive global inspection readiness through structured planning, mock inspections, and cross-functional preparedness activities to support successful regulatory submissions and approvals.
- Oversee vendor and CRO quality management, including selection, qualification, governance models, performance monitoring using KPIs, and compliance with quality agreements.
- Identify and mitigate systemic quality risks across the clinical portfolio, influence development strategies, and ensure effective escalation to senior leadership.
- Monitor, trend, and report quality metrics such as KPIs, QTLs, TMF health, and CAPAs, using insights to drive continuous improvement and operational excellence.
- Provide QA oversight of pharmacovigilance activities, ensuring compliance with safety reporting requirements and vendor performance expectations.
- Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, and Pharmacovigilance to drive quality, compliance, and continuous improvement.
- Drive QA innovation through adoption of digital tools, advanced analytics, and modern risk-based quality approaches.
- Build, scale, and lead a high-performing global GCP QA organization, fostering a culture of quality, accountability, and operational excellence.
- Serve as a subject matter expert on GCP, GLP, and PV regulations, advising senior leadership and influencing quality strategy across the organization.
Desired Qualifications
- Experience implementing advanced risk-based quality management frameworks and using analytics-driven approaches, such as centralized monitoring and signal detection, to enhance clinical quality oversight.
- Prior experience in a small-to-mid-size biotech environment, with demonstrated ability to build and scale QA functions within highly outsourced, global clinical development models.
About the company
Revolution Medicines develops targeted therapies for cancers caused by RAS mutations, which are found in about 30% of human cancers. The company’s products are small molecules called RAS(ON) inhibitors that work by blocking the active, cancer-promoting form of the RAS protein to stop tumor growth. Unlike older treatments that could only target a few specific mutations, this platform creates inhibitors that can address a much wider range of RAS-driven cancers. The company's goal is to advance these candidates through clinical trials to provide effective treatment options for patients with previously "undruggable" forms of cancer.
Company Size
1,001-5,000
Company Stage
IPO
Headquarters
Redwood City, California
Founded
2014
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Simplify's Take
What believers are saying
- FDA approved RASONQUE on August 26, 2026, six months ahead of deadline.
- RASolute 302 cut death risk 60% and doubled median overall survival to 13.2 months.
- Royalty Pharma's June 2025 $2 billion package funds commercialization and global expansion through 2027.
What critics are saying
- RASONQUE costs $39,800 monthly, inviting Medicare and commercial payer restrictions in 2026.
- Revenue still depends overwhelmingly on one launch; any RASONQUE setback crushes the company.
- AstraZeneca, Amgen, and Mirati pressure RAS programs; resistance or safety issues can erase the franchise.
What makes Revolution Medicines unique
- RASONQUE became the first approved broad RAS(ON) inhibitor on August 26, 2026.
- Revolution Medicines avoids companion diagnostics and treats metastatic PDAC with or without RAS mutations.
- Its pipeline spans daraxonrasib, elironrasib, and zoldonrasib across pancreatic, lung, and colorectal cancers.
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Benefits
- Company Equity