Associate Director, Clinical Operations
New Today
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.
- 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.
The base salary range for this full-time position is $180,000 to $225,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
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 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 privacy@revmed.com.
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- Location:
- Redwood City
- Job Type:
- FullTime