Job Type
Full-time
Description
Who You AreWe are seeking an
Associate Director, Clinical Operations to lead execution of BBOT's clinical trials across all phases, with a focus on early-phase oncology. Reporting to the Director of Clinical Operations, the Associate Director will serve as the operational lead for assigned studies, driving day-to-day trial management while providing guidance to Clinical Trial Managers and supporting the Director on cross-functional and portfolio-level priorities. The Associate Director will work closely with CROs, vendors, investigators, and internal stakeholders to ensure high-quality, timely clinical data delivery. Global trial experience is required.
Responsibilities- Lead day-to-day clinical trial execution for assigned studies, with full ownership of site activation, enrollment, monitoring, and closeout activities
- Serve as the primary clinical operations lead for assigned programs, acting as the main point of contact for CROs, vendors, and clinical sites
- Lead cross-functional trial team meetings, driving alignment on deliverables, timelines, and risk mitigation strategies, and escalating portfolio-level issues to the Director as appropriate
- Provide day-to-day direction and mentorship to Clinical Trial Managers, supporting their development and ensuring consistent quality of study execution across the team
- Manage CRO and vendor relationships for assigned studies, overseeing deliverables, performance metrics, and issue resolution in partnership with the Director
- Drive vendor integration strategies to ensure seamless execution between CRO, central labs, and specialty service providers
- Own study budget tracking and forecasting for assigned programs, providing regular reporting and flagging variances to the Director
- Review vendor invoices against scope of work and work completed to date; identify and communicate variances to the Director
- Ensure completeness and inspection-readiness of the trial master file (TMF/eTMF) across assigned studies
- Lead the development and maintenance of key operational documents including study manuals, ICFs, tracking tools, and monitoring plans
- Monitor regulatory and GCP compliance across all trial activities for assigned studies; lead audit and inspection readiness preparation and support the Director during inspections
- Review clinical trial data listings to identify and drive resolution of protocol deviations, data trends, and outstanding queries
- Coordinate timely data review to identify trends and discrepancies; support the Director in contributing to abstracts, presentations, and manuscripts as needed
- Oversee lab sample management processes, including sample tracking, shipment, reconciliation, and vendor coordination to ensure timely and compliant handling of biological specimens
- Coordinate and plan for availability of clinical and non-clinical supplies required for trial execution
- Lead SOP development and implementation for assigned areas; contribute to continuous process improvement initiatives across clinical operations
- Cultivate and maintain strong working relationships with investigators and trial site managers to support site performance
- Represent clinical operations in cross-functional team meetings and contribute to governance discussions, with escalation to the Director for portfolio-level decisions
- Contribute to operational feasibility assessments and support protocol development in collaboration with cross-functional teams and the Director
Requirements
RequirementsEducation and Qualifications - Bachelor's degree in life sciences or related field
- Minimum 8-10 years of experience in Clinical Operations, managing clinical trials within the biopharma industry, including global trial experience
- Demonstrated ability to independently lead clinical trials from start-up through close-out, including financial tracking, reporting, and vendor management
- Experience providing direction or informal management to CTMs or equivalent clinical operations staff; formal people management experience a plus
- Strong understanding of CRO/vendor oversight and clinical development processes, with a proven track record managing complex, multi-vendor programs
- Experience with cross-functional leadership and clinical teams, including data review and study reporting activities
- Early-phase oncology experience preferred
- Prior experience in a lean or startup environment is highly desirable
- Experience in maintenance of a submission-ready eTMF required
- Experience in Quality Assurance, SOP and study plan writing, and audit/inspection readiness
- Strong knowledge of ICH-GCP and global regulatory requirements
- Proficient in clinical trial systems (e.g., EDC, CTMS, eTMF), timeline management tools (e.g., Smartsheet), and Microsoft Office Suite
- Excellent project management, communication, and problem-solving skills; demonstrated ability to lead and influence in a cross-functional environment
Salary Description
$175,000 - 245,000
