Senior Director, Clinical Operations

Revolution Medicines•Redwood City, CA

2d•$244,000 - $305,000•Hybrid

About The Position

Revolution Medicines is seeking a Senior Director of Clinical Operations to provide operational design and structure for, and lead execution of, early-stage clinical studies. The role oversees development, management, and execution of Clinical Development Plans for clinical programs, including trial timelines, budgets, and resource needs. It also oversees trial execution, including CRO and site selection, and plans and deploys Clinical Operations staff across project and non-project work. The Senior Director establishes team roles and responsibilities, supports skill development and career growth, and carries line-management responsibilities including hiring, performance management, career development, and mentorship. The role works with internal functional groups to achieve clinical study goals in accordance with applicable regulations and ICH/GCP guidelines. It represents Revolution Medicines in interactions with key opinion leaders, scientific advisors, corporate partners, and, where necessary, investors.

Requirements

BS/MS degree in a scientific discipline.
At least 12 years of clinical operations experience in the pharmaceutical or biotechnology industry.
At least 7 years of project and line management experience.
Extensive experience leading and managing global Phase 1–3 clinical trials within designated timelines, resources, and budgets.
Demonstrable record of strong leadership and teamwork.
Extensive experience selecting CROs/vendors and managing external resources.
Working knowledge of data management, data review and analysis, drug safety, pharmacovigilance, and related functions as they pertain to clinical trial conduct.
Strong working knowledge of FDA regulations and ICH guidelines and GCPs governing clinical trials.
Ability to thrive in a collaborative team setting and pursue innovative approaches and technologies in a high-energy environment.
Excellent written and verbal communication skills.
Ability to multitask, prioritize, anticipate challenges, and execute goals as part of an interdisciplinary team.

Nice To Haves

Experience with cooperative group studies and investigator-sponsored trials.
Experience in oncology clinical trials.

Responsibilities

Develop, manage, and execute Clinical Development Plans for clinical programs, including clinical trial timeline estimates, budgets, and resource requirements.
Oversee clinical trial execution, including CRO selection and site selection.
Plan and deploy Clinical Operations staff for project and non-project tasks.
Establish clear roles and responsibilities for team members and provide opportunities for skill development and growth.
Hire, manage performance, support career development, and mentor direct reports.
Participate in or lead team meetings and collaborate with functional groups such as Clinical Development, DMPK, Regulatory, QA, Finance, and Legal to achieve clinical study goals.
Ensure clinical study activities align with applicable regulations and ICH/GCP guidelines.
Represent Revolution Medicines in interactions with key opinion leaders, scientific advisors, corporate partners, and, where necessary, investors.