Associate Director, Clinical Operations
BioSpace
Date: 5 hours ago
City: South San Francisco, CA
Contract type: Full time

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
Responsibilities
- 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 mentoring
- Strong understanding of the cost drivers and accountable for the development, management, reconciliation of overall study budget(s)
- Review/approve invoices, manage monthly accruals, and ensures timely payment processing for vendors including investigative sites (as applicable)
- Demonstrated ability to effectively collaborate with study team members to achieve the established goals within the expected time frames
- Develop, review, update, and add SOPs as required
- Develop and maintain professional relationships with opinion and thought leaders
- Representing the company at meetings with external attendees
- Lead study execution teams in collaboration with clinical development lead
- Highly motivated and enjoys working in a fast-paced environment
- Strong organizational skills and the ability to prioritize and multi-task
- Ability to work independently and under pressure with changing priorities
- Possess strategic thinking and proactive identification of issues
- Excellent judgment and problem-solving skills
- Exceptional verbal and written communication skills
- Flexible as it relates to responsibilities/assignments since Sutro is a small company and job scope/role will inevitably evolve as the company and department matures
- Willingness to travel as necessary, consistent with project needs
- Computer proficiency (Outlook, MS Word, Excel, and PowerPoint)
- Able to interact cross-functionally at all levels within Sutro and externally with consultants/contractors, investigators, and study coordinators
- Ability to operate and cooperate at all levels within a project, from oversight to hands-on management of day-to-day activities
- Bachelors/Master’s (or equivalent) in a health care or other scientifically related field with 15+ years of related industry experience as a CRA/Manager or related function with increasing responsibility and scope
- Previous experience in the management of global Oncology clinical trials, early phase is a plus
- 10+ years of monitoring experience, ideally with a mix of CRO and biopharmaceutical experience
- Strong background in drug development; working knowledge of details and issues involved in different functional areas (i.e. data management, pharmacovigilance, regulatory, biostats, etc.)
- Demonstrated experience in selecting, managing, and overseeing CROs and multiple vendors
- Strong knowledge of FDA/EMA regulatory requirements and ICH/GCP guidelines
- Office based position with some travel (domestic and international), up to 25%.
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resume