Director, Clinical Operations

Revolution Medicines•Redwood City, CA

2h•$211,000 - $264,000•Hybrid

About The Position

Revolution Medicines is seeking a Director, Clinical Operations to oversee the CRO oversight, execution, and management of its clinical trials. The role calls for leadership and organizational skills, technical expertise in clinical oncology drug development in an industry setting, and experience overseeing clinical trials. The director will serve as a strategic thought partner on clinical development plans, oversee study management and vendor performance, and lead Clinical Operations staff. This position collaborates with cross-functional teams to achieve study goals and maintains trial inspection readiness throughout the trial lifecycle. Travel may be required, approximately 25%.

Requirements

RN, bachelor's degree, or master's degree in biological sciences or a health-related field.
15 years of direct Clinical Operations experience in the pharmaceutical or biotech industry; relevant indirect experience may also meet the requirement.
At least 9 years of project and first-line management experience.
Experience leading and managing global Phase 1–3 clinical trials within designated timelines, resources, and budgets.
Strong working knowledge of FDA regulations, ICH Guidelines, and GCP.
Experience with vendor management and CRO oversight.
Ability to perform complex analysis, draw relevant conclusions, and implement appropriate solutions.
Ability to pivot and be solution-oriented while considering long-term impacts on clinical trials, responsibilities, and inspection readiness.
Strong analytical, negotiation, and persuasion skills.
Ability to handle time demands, incomplete information, and unexpected events.
Outstanding organizational skills and ability to multitask and prioritize.
Excellent interpersonal, verbal, and written communication skills.
Decision-making skills.
Comfort in a fast-paced company environment and ability to adjust workload as priorities change.
Proficiency in Microsoft Office Suite, including Outlook, Word, Excel, and PowerPoint.
Willingness to travel as required, approximately 25%.

Nice To Haves

Proficiency with MS Project and/or Smartsheet.
Proven success collaborating with vendor systems or portals, such as eTMF, EDC, IRT, and CTMS.
Oncology experience, in early- and/or late-stage development.
Knowledge of or familiarity with clinical trial operations in Ex-US regions.
Experience working with cooperative group studies and investigator-sponsored trials.

Responsibilities

Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) Guidelines.
Oversee successful management of all clinical-trial aspects within timelines and designated program budgets.
Contribute strategically to developing, managing, and executing Clinical Development Plans for assigned programs, including timelines, budgets, resource requirements, critical-path activities, and risk mitigation.
Plan and deploy Clinical Operations staff and consultants for project-related and non-project-related tasks.
Lead line management, including hiring, performance management, career development, and mentorship.
Manage and oversee CROs and selected study vendors, monitoring milestones, budgets, timelines, vendor performance, metrics, and KPIs.
Lead team meetings and collaborate with Clinical Development, Regulatory, Quality Assurance, Finance, Legal, and other functional groups to achieve clinical study goals.
Ensure clinical trials remain inspection-ready throughout their lifecycle.
Improve processes affecting clinical trial management and deliverables, including contingency planning, while maintaining an effective Clinical Operations team and strong relationships with functional leaders.