Associate Director, Clinical Operations jobs in United States
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Revolution Medicines · 1 week ago

Associate Director, Clinical Operations

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The Associate Director of Clinical Operations will oversee the execution and management of clinical trials, ensuring adherence to regulatory guidelines and successful project delivery.

Health CareLife ScienceMedical
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H1B Sponsor Likelynote

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 includes 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 evaluate 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

Qualification

Clinical Operations experienceFDA Regulations knowledgeCRO oversightProject management experienceOncology experienceVendor managementGCP knowledgeAnalytical skillsMicrosoft Office proficiencyInterpersonal skillsCommunication skillsDecision-making skillsOrganizational skillsNegotiation skillsProblem-solving skills

Required

RN or Bachelor's or Master's degree in biological sciences or health-related field required
11+ years direct Clinical Operations experience in the pharmaceutical or biotech industry. Relevant indirect experiences may also meet the requirement
Minimum of 5 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

Proven success working 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

Benefits

Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities

Company

Revolution Medicines

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Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.

H1B Sponsorship

Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$2.25B
Key Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M

Leadership Team

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Luan Wilfong
Chief Human Resources Officer
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Steve Kelsey
President
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Company data provided by crunchbase