Temp Associate Director, Clinical Operations en Revolution Medicines

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 Revolutionaries 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. As an Associate Director in Clinical Operations, you will be responsible for acting as a central contact for the Clinical Study Team(s) and assist with the execution and management of Revolution Medicines (RevMed) clinical trials.

• Adhere to Clinical Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.

• Be a team leader, providing guidance and oversight for the successful management of all aspects of clinical trials within timelines and designated program budgets.

• Review and comment on the development, management, and execution of the Clinical Development Plan (CDP) 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.

• 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.

• Line management responsibilities 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 key performance indicators (KPIs).

• Able to pivot, be solution-oriented with consideration to long-term impact on clinical trials, responsibilities, and inspection-readiness.

• Participate in team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Regulatory, Quality Assurance, Finance, Legal, etc.) to achieve clinical study goals.

• Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial.

• Partner with Clinical Operations team members and functional peers to improve process that willimpact clinical trial management and deliverables including contingency plans.

Required Skills, Experience, and Education:

• Bachelor’s degree in biological sciences or health-related field required.

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

• Minimum of 4 years of project and line management experience.

• Extensive 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.

• 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:

• RN or Masters degree in biological sciences or health-related field preferred.

• Has familiarity 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.

This is a contract position that will be employed through a third-party recruiting agency. The agency will provide the pay range, which will be based on several factors, including job-related skills, experience, market conditions, and relevant education or training.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Revolution Medicines takes the protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [email protected]. #LI-Hybrid  #LI-AP1