Director, Clinical Operations (Medical Affairs)

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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

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 organizing and overseeing clinical trials, including Medical Affairs studies. As a Director, you will be responsible for the operational design and team structure of, and accountable for the oversight and general execution of, externally sponsored research (including investigator-sponsored, collaborative research and cooperative group trials), post-registrational clinical trial commitments, and overseeing operations of expanded access and other related programs.

• Establish a governance and structured approach to execute a growing portfolio of medical affairs studies and ensure compliance with RevMed Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines, and patient safety standards to maintain inspection readiness.

• Provide strategic operational guidance to ensure that clinical trials are properly defined, planned, and executed across all assigned clinical stage programs.

• Strategic contributor to the development, management, and execution of evidence gathering and Integrated Evidence Plan (IEP) 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.

• 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: hiring, performance management, career development, and mentorship.

• Accountable for the oversight and execution of multiple clinical trials. Member of core team(s) providing strategic direction to study teams to meet corporate goals and timelines.

• Enable clinical programs to be executed within the projected budget and promptly communicate any change in the scope of the budget.

• Participate in and/or lead any vendor governance activities for key CRO/vendor partners.

• Support Medical Affairs teams with long range planning, scenario analysis, and annual budget planning activities.

• Recommend and implement innovative processes to improve and impact clinical trial management and deliverables including contingency plans.

Required Skills, Experience and Education:

• RN or bachelor’s or master’s degree in biological sciences or health-related field required.

• 12+ years direct Clinical Operations experience in the pharmaceutical or biotech industry. Relevant indirect experience may also meet this requirement.

• Minimum of 7 years of managing project teams and line management of multiple employees and managers

• Experience in overseeing post-marketing, investigator sponsored and expanded access programs.

• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP related to late stage or post marketed products.

• Strong strategic/conceptual skills that can bridge the gap between different interdisciplinary departments, (medical affairs, commercial and development) to build a compliant clinical operations structure and team.

• A demonstrable record of strong leadership and teamwork

• Experience in evaluating, negotiating, and managing multiple successful relationships with partners, ability to set up milestones to track progress and collaborating with partners.

• 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, with ability to interact with colleagues and partners at all levels of experience are expected.

• Strong Decision-making skills

• Comfortable in a fast-paced company enviro