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Associate Director, Clinical Operations
Sutro Biopharma, Inc.South San Francisco, United Statesfull_timeVerifiedPosted 28 May 2025
š° $200,000/yr($186,000/yr ā $200,000/yr)
About the role
Position Overview:Sutro Biopharma, Inc. is looking for a dynamic and experienced Associate Director, Clinical Operations, who will be responsible and accountable for managing the overall clinical operational activities for a study/program and may assume responsibility for additional studies/indications as they become available. The Associate Director, Clinical Operations provides strategic and operational leadership to ensure the study/program milestones are delivered on time, within budget, with high quality, and in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs. The Associate Director, Clinical Operations will provide input to or establish new processes, work instructions, and SOPs to ensure consistent, effective, and efficient execution of clinical operations activities across the department.
Responsibilities:Ā
Responsibilities:Ā
- Manage multi-site clinical trials/programs involving internal and external collaborators such as CROs and various clinical vendors
- Accountable for the tactical implementation of the clinical development plan by managing the timeline, resources, and budget of clinical activities within a study/program
- Work closely with the Clinical Science team to ensure the Operational plans/activities are executed and delivered with quality and on budget from study start-up to Clinical Study Report finalization
- Participate in or accountable for the selection process of CROs and vendors for assigned studies
- Responsible for assisting with strategic planning for site/country selection, contract negotiations with vendors, patient recruitment, ensuring proper study conduct, and budget forecasting
- Responsible for the operational aspects of development and delivery of study protocols, informed consents, study plans, quality initiatives, etc. needed to conduct clinical trials
- Review site contracts and work closely with the Legal department to ensure execution of contracts to planned timelines
- Serve as the escalation point for internal/external team members and clinical sites
- Proactively identify and remediate study issues
- Work with other functions to ensure GCP compliance and inspection readiness is maintained throughout the study
- Conduct Sponsor Oversight visits to assess sites/CRAs in adherence to study plans, protocol, and GCP as needed
- Provide management with timely updates on progress and changes in scope, schedule, and resources within a study(ies), as applicable
- Line management capabilities including providing guidance, performance development, coaching and
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