Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

• Lead the development, enhancement, and implementation of best practices within Clinical Data Science, Analytics, and Systems (CDSAS) concerning quality and compliance by building quality into internal processes, leading to constant inspection readiness.
• Contribute to the development and implementation of standards and guidelines for data monitoring and risk management ensuring a “fit for purpose” approach and consistency/standardization between teams to be deployed within each program team.
• Contribute to the development and implementation of processes to ensure data integrity is maintained for the full data lifecycle and that data acquisition tools are fit for purpose.
• Proactively facilitate risk-based quality management activities with the relevant stakeholders for identification of critical quality factors, and identification, evaluation, control, communication, review, and reporting of risks according to ICH E6(R3).
• Collaborate with stakeholders across Clinical Operations, Clinical Data Science, Clinical Systems, Statistical Programming, and vendors to implement standardized quality metrics, deploy compliance measures, oversee quality risks and events, generate and facilitate action items.
• Lead cross-functional teams, influencing without authority, to develop new strategies and initiatives to establish scalable solutions and standards.
• Drive project teams and functions to comprehensively improve operating process, process simplification, data & technology enablement regarding quality by design, while ensuring quality standards and regulatory compliance.
• Synthesize clear takeaways from complex information into outcomes and recommendations using both qualitative and quantitative methods (i.e. external benchmarks, internal metrics, process performance analyses, etc.)
• Draft and maintain the documentation of risk management activities e.g., risk/issue(s), controls, findings, escalations, tracking and resolution.
• Maintain awareness of existing and new internal and external regulations and guidance pertaining to GCP, ICH, data integrity, system validation etc. assessing impact and providing recommendations where required. Acts as an internal SME for quality-related matters.
• Other relevant duties as assigned.

Required Skills, Experience and Education:

• At least 7-10 years of pharmaceutical industry or related experience
• MS, BS/BA life sciences degree or other suitable qualification with relevance to the pharmaceutical industry.
• Extensive experience in data governance, risk-based quality management, and compliance activities in the pharmaceutical industry. Strong knowledge of the industry’s Research and Development environment, regulations, and best practices.
• Effective, customer focused, responsive, accountable, and possesses excellent written and verbal communication skills.
• Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute is extremely important.

Preferred Skills:

• Experience with early-stage oncology clinical trials
• Understanding of IT systems software lifecycle (SLC), server qualification, data flow, and security, program development life cycle.
• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high energy environment.
• Understanding of CDISC standards and submission guidelines

The base salary range for this full-time position is $180,000 to $225,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base salary 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.