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.

Who You Are

We are seeking a Clinical Trial Manager (CTM) or Senior Clinical Trial Manager (Sr. CTM) (Sr. CTM) to support the execution of BBOT’s clinical trials across all phases, with a focus on early-phase oncology. Reporting to the Director of Clinical Operations, the Sr. CTM will play a critical role in supporting cross-functional planning, day-to-day oversight of trial activities, and ensuring the delivery of high-quality, timely clinical data. The Sr. CTM will work closely with internal and external partners, including CROs, vendors, and clinical sites. Global trial experience a plus. 

Responsibilities

• Support the Director in overseeing global clinical trial execution, including site activation, enrollment, monitoring, and closeout
• Support the Director in leading      cross functional trial team meetings and ensure alignment on key deliverables, timelines, and risk mitigation strategies. 
• Manage day-to-day operational activities for assigned studies, ensuring adherence to timelines, budgets,  and quality standards
• Drive vendor integration strategies to ensure seamless execution between CRO, central labs, and any specialty service providers. 
• Act as the main clinical operations point of contact for assigned study-level tasks, including managing CROs and vendors in collaboration with the Director
• Ensure completeness and inspection-readiness of the trial master file (TMF/eTMF) 
• Support the development and maintenance of key operational documents including study manuals, ICFs, tracking tools, and monitoring plans
• Participates in the conduct of audits and support regulatory inspections related to GCP
• Monitor regulatory and GCP compliance across trial activities and support audit/inspection readiness
• Review clinical trial data listings to support identification and resolution of protocol deviations, data trends, and outstanding queries
• Own CRO and vendor oversight by      tracking deliverables, proactively identifying risks until issue resolution, and performance metrics in partnership with the Program/Study Lead
• Oversee lab sample management processes, including sample tracking, shipment, reconciliation, and vendor coordination to ensure timely and compliant handling of biological specimens
• Contributes to continuous  process improvement and SOP development 
• Participate in team meetings, providing clinical operations insights and updates to internal stakeholders

Additional Responsibilities (Sr. CTM only)

• Lead cross-functional trial team meetings and drive alignment on key deliverables, timelines, and risk mitigation strategies with minimal oversight
• Serve as primary clinical operations lead for assigned programs, representing the function in governance and leadership meetings
• Provide strategic input into study design, operational feasibility, and protocol development in collaboration with cross-functional teams
• Lead SOP development and drive continuous improvement initiatives across clinical operations
• Mentor and develop CTMs and junior team members to build internal operational capabilities and a high-performing team culture

Education and Qualifications – Clinical Trial Manager (CTM) 

• Bachelor’s degree in life sciences or related field
• Minimum 4 years of experience in Clinical Operations, working with CROs and other vendors
• Strong understanding of CRO/vendor oversight and clinical development process
• Early-phase oncology experience  preferred
• Prior experience in a lean or startup environment is highly desirable
• Excellent project management, communication, and problem-solving skills
• Working knowledge of ICH-GCP and global regulatory requirements
• Proficient in clinical trial systems (e.g., EDC, CTMS, eTMF) and Microsoft Office Suite
• Excellent project management,  communication, and problem-solving skills

Education and Qualifications – Senior Clinical Trial Manager (Sr. CTM) 

• Bachelor’s degree in life  sciences or related field
• Minimum 6 years of experience  in Clinical Operations, working with CROs and other vendors
• Strong understanding of CRO/vendor oversight and clinical development process, with demonstrated ability to operate independently across complex, multi-vendor programs
• Early-phase oncology experience  preferred; proven track record managing cross-functional trial teams
• Prior experience in a lean or  startup environment is highly desirable
• Excellent project management, communication, and problem-solving skills; demonstrated ability to lead  and influence without direct authority
• Working knowledge of ICH-GCP and global regulatory requirements

Proficient in clinical trial systems (e.g., EDC, CTMS, eTMF) and Microsoft Office Suite