Associate Director, Clinical Operations

Revolution Medicines • Redwood City, CA

112d • $180,000 - $225,000

About The Position

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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. 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 an Associate Director, you will be responsible for the Contract Research Organization (CRO) oversight, execution, and management of Revolution Medicines (RevMed) clinical trials.

Requirements

• 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.
• 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.
• Strong analytical, negotiation, and persuasion skills.
• 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.

Nice To Haves

• 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.

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.
• Identify critical path activities and articulate and mitigate risks to clinical trial conduct.
• Responsible for successful planning and deployment of Clinical Operations staff 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.
• Evaluate vendor performance using metrics and KPIs.
• Lead team meetings and collaborate with other functional groups within the company 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.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree