Senior Director, Clinical Operations

Revolution Medicines • Redwood City, CA

51d • Hybrid

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. The Opportunity: This is a unique opportunity for the right individual who has innate leadership and organizational skills, technical expertise in clinical oncology drug development in an industry setting, and experience in organizing and running clinical trials. As the Senior Director of Clinical Operations, you will be responsible for the operational design and structure of, and accountable for the execution of, Revolution Medicines early-stage clinical studies. Specifically, you will be responsible for:

Requirements

• BS/MS Degree in a scientific discipline with a minimum of 12 years of clinical operations experience in the pharmaceutical or biotech industry.
• Minimum of 7 years project and line management experience.
• Extensive experience in leading and managing global phase 1-3 clinical trials within designated timelines, resources, and budgets.
• A demonstrable record of strong leadership and teamwork.
• Extensive experience in selection of CROs/ vendors and management of external resources.
• Must have a working knowledge of data management, data review and analysis, and drug safety, pharmacovigilance and other related functions as related to clinical trial conduct.
• Strong working knowledge of FDA Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials.
• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high energy environment.
• Excellent written and verbal communication skills.
• Ability to act as an excellent ambassador for Revolution Medicines in interactions with key opinion leaders, scientific advisors, corporate partners and, where necessary, investors.
• Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important.

Nice To Haves

• Experience in working with cooperative group studies and investigator sponsored trials, preferred.
• Experience in oncology clinical trials.

Responsibilities

• The development, management, and execution of the Clinical Development Plan (CDP) for clinical programs which includes clinical trial timeline estimates, budgets, and resource requirements.
• Oversight over the execution of clinical trials, including CRO selection and site selection.
• Successful planning and deployment of Clinical Operations staff for project and non-project related tasks. Establish clear roles and responsibilities for team members and include opportunities to stretch skills and enable growth.
• Line management responsibilities include hiring, performance management, career development and mentorship.
• Participate in or lead team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, DMPK, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals regulations and International Council for Harmonization (ICH)/ GCP guideline.

What This Job Offers

• Job Type: Full-time
• Career Level: Director