Director, Clinical Operations

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 overseeing clinical trials. As a director, you will be responsible for the Contract Research Organization (CRO) oversight, execution, and management of Revolution Medicines (RevMed) clinical trials.

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 include timelines, budget, and resource requirements.
• Ability to identify critical path activities and articulate and mitigate risks to clinical trial conduct.
• Responsible for successful planning and deployment of Clinical Operations staff (potentially including Clinical Program Managers/Clinical Trial Managers/Clinical Trial Assistants, and consultants) 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, as well as evaluating vendor performance using metrics and KPIs.
• Lead team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Regulatory, QA, Finance, Legal, etc.) 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 including contingency plans by maintaining a highly effective Clinical Operations team and building strong relationships with functional leaders.

Required Skills, Experience and Education

• RN or Bachelor's or Master's degree in biological sciences or health-related field required.
• 15 years direct Clinical Operations experience in the pharmaceutical or biotech industry. Relevant indirect experiences may also meet the requirement.
• Minimum of 9 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.
• Ability to pivot, be solution-oriented with consideration to long-term impact on clinical trials, responsibilities, and inspection-readiness.
• Strong analytical, negotiation, and persuasion skills.
• 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.
• 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.
• Travel may be required (~25%).

Preferred Skills, Experience and Education

• Proven success in collaborating 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.