Associate 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 an Associate 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.

• Global experience in end-to-end execution of different phases of clinical trials.

• Accountable for study delivery goals. Oversee the successful management of all aspects of clinical trials within timelines and designated program budgets.

• Guide assessment, selection, engagement, management, and oversight of appropriate vendors.

• Responsible for making decisions that balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.

• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness. Lead/contribute to ways of working and process improvement initiatives.

• Provide proactive and consistent oversight of CRO and vendor performance Support Clinical Operations Program and / or Indication Lead with key study level status updates, with a particular focus on delivery to corporate and project level objectives.

• Contributions to the strategy 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 evaluate vendor performance using metrics and KPIs.

• Lead cross functional 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.

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

• Minimum of 5 years of project and first-line management experience.

• Experience in oncology.

• 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%).

• Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change.

• In-depth knowledge of either study management or data management and knowledge of essential global regulatory guidelines and ICH/GCP.

• Proven experience working with investigators, external experts and regulatory agencies and oversight of Contract Research Organizations and third-party vendors including realigning with CRO partners when deliverables are at risk, negotiating solutions and leading After Action Reviews to share lessons learned.

• Excellent project management skills and budget management skills.

Preferred Skills:

• Proven success working 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. 

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