Director, Clinical Operations

revolutionmedicines; Redwood City (CA); Hybrid; USD 250,000 - 300,000; Full time

Job summary

Revolution Medicines in Redwood City, CA seeks a Director of Clinical Operations to lead CRO oversight, trial execution, and program management for oncology studies. You will manage timelines, budgets, vendor relationships, and the Clinical Development Plan, while mentoring a team and ensuring GMP/GCP compliance.

Ideal candidates have RN or advanced degree, 15+ years in clinical operations and 9+ years of first-line management, with strong FDA/ICH knowledge and global trial experience; some

Qualifications

• RN or Bachelor's or Master's degree in biological sciences or health-related field.
• 15 years of direct Clinical Operations experience in pharma/biotech.
• Minimum 9 years of project and first-line management experience.
• Experience with global phase 1-3 trials, timelines, budget and resources.
• Strong FDA/ICH/GCP knowledge and vendor/CRO oversight.

Responsibilities

• Oversee CRO management and clinical trial execution within timelines and budgets.
• Lead CDP development, timelines, budget and resource requirements; identify critical path activities.
• Plan and deploy clinical operations staff for project tasks and provide mentorship.
• Lead team meetings and collaborate with Clinical Development, Regulatory, QA, Finance and Legal.
• Maintain inspection readiness and drive process improvements in trial management.

Skills

Leadership

Vendor management

Program management

Budget management

FDA/ICH/GCP knowledge

Strategic thinking

Communication

Mentorship

Education

RN or Bachelor's or Master's in biological sciences

Tools

MS Office Suite

MS Project/Smartsheet

Job description

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor-all in service of patients.

The Opportunity:

This is a unique opportunity for a Clinical Operations Professional who has innate leadership and organizational skills, technical expertise in clinical oncology drug development in an industry setting, and experience in overseeing clinical trials. As a director, you will be responsible for the Contract Research Organization (CRO) oversight, execution, and management of Revolution Medicines (RevMed) clinical trials.

Responsibilities:

• Adhere to Clinical Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.
• Oversee the successful management of all aspects of clinical trials within timelines and designated program budgets.
• Strategic thought partner on the development, management, and execution of the Clinical Development Plan (CDP) for assigned clinical programs which include timelines, budget, and resource requirements. Ability to identify critical path activities and articulate and mitigate risks to clinical trial conduct.
• Responsible for successful planning and deployment of Clinical Operations staff (potentially including Clinical Program Managers/Clinical Trial Managers/Clinical Trial Assistants, and consultants) for project and non-project related tasks.
• Lead line management responsibilities that include hiring, performance management, career development, and mentorship.
• Manage/oversee CROs and selected study vendors; ensuring all vendors strive to achieve the predetermined program milestones according to budget and timeline, as well as evaluating vendor performance using metrics and KPIs.
• Lead team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals.
• Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial.
• Oversee the improvement of processes that will impact clinical trial management and deliverables including contingency plans by maintaining a highly effective Clinical Operations team and building strong relationships with functional leaders.

Required Skills, Experience and Education:

• RN or Bachelor's or Master's degree in biological sciences or health-related field required.
• 15 years direct Clinical Operations experience in the pharmaceutical or biotech industry. Relevant indirect experiences may also meet the requirement.
• Minimum of 9 years of project and first-line management experience.
• Experience in 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, be solution-oriented with consideration to long-term impact on clinical trials, responsibilities, and inspection-readiness.
• Strong analytical, negotiation, and persuasion skills.
• Ability to deal with time demands, incomplete information, or unexpected events.
• Outstanding organizational skills with the ability to multi-task and prioritize.
• Excellent interpersonal, verbal, and written communication skills.
• Decision-making skills.
• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.
• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
• Travel may be required (~25%).

Preferred Skills, Experience and Education:

• Proven success in collaborating with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
• Oncology experience, early and/or late stage, strongly preferred.
• Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.
• Experience in working with cooperative group studies and investigator sponsored trials preferred.

#L1-DN1 #L1-Hybrid

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