Senior Director, Clinical Operations

Revolution Medicines•Redwood City, CA

2d•Hybrid

About The Position

Revolution Medicines is seeking a Senior Director of Clinical Operations to provide operational design and structure for, and oversee execution of, early-stage clinical studies. The role includes developing and managing Clinical Development Plans, including trial timelines, budgets, and resource requirements; overseeing clinical trial execution, CRO and site selection; and planning and deploying Clinical Operations staff. The Senior Director will establish team roles and responsibilities, support skill development, and manage staff through hiring, performance management, career development, and mentorship. The position also participates in or leads team meetings and collaborates with cross-functional groups to achieve clinical study goals in accordance with applicable regulations and ICH/GCP guidelines.

Requirements

BS or MS degree in a scientific discipline.
At least 12 years of clinical operations experience in the pharmaceutical or biotech 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.
Demonstrated strong leadership and teamwork.
Extensive experience selecting CROs and vendors and managing external resources.
Working knowledge of data management, data review and analysis, drug safety, pharmacovigilance, and related functions in clinical trial conduct.
Strong working knowledge of FDA regulations, ICH guidelines, and GCPs governing clinical trials.
Excellent written and verbal communication skills.
Ability to multitask, prioritize options, anticipate challenges, and execute goals as part of an interdisciplinary team.
Ability to thrive in a collaborative, high-energy team setting and a desire to deploy innovative approaches and technologies.

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 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.
Manage staff, including hiring, performance management, career development, and mentorship.
Participate in or lead team meetings.
Collaborate with Clinical Development, DMPK, Regulatory, QA, Finance, Legal, and other functional groups to achieve clinical study goals.
Ensure clinical study conduct complies with regulations and ICH/GCP guidelines.
Represent Revolution Medicines in interactions with key opinion leaders, scientific advisors, corporate partners, and, where necessary, investors.