Associate Director, Clinical Operations

BBOT; United States; On-site; USD 175,000 - 245,000; Full time

Job summary

BridgeBio Oncology Therapeutics is seeking an Associate Director of Clinical Operations to lead global oncology trials. You will serve as the operational lead, overseeing trial management, CRO/vendor relationships, and data delivery across phases.

This role requires leadership of cross-functional teams and strong regulatory knowledge. The position focuses on early-phase oncology, with responsibility for budgets, timelines, and inspection readiness, reporting to the Director of Clinical

Qualifications

• 8–10 years of Clinical Operations experience, globally.
• Lead cross-functional trial teams and vendor management.
• Experience managing early-phase oncology trials preferred.
• Strong knowledge of ICH-GCP and regulatory requirements.
• Experience with eTMF/CTMS/EDC systems.

Responsibilities

• Lead day-to-day trial execution from start-up to close-out.
• Be the main contact for CROs, vendors, and sites.
• Oversee trial budgets, timelines, and risk mitigation.
• Mentor Clinical Trial Managers and ensure quality.
• Support regulatory inspections and TMF readiness.

Skills

Cross-functional leadership

Project management

Communication

Problem-solving

People management

Influence in cross-functional teams

Education

Bachelor’s degree in life sciences

Tools

EDC

CTMS

eTMF

Smartsheet

Microsoft Office

Job description

About BridgeBio Oncology Therapeutics

BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information visit BBOTx.com.

Job Type

Full-time

Description

BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information visit BBOTx.com.

Who You Are

We 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

• 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