Director, Development and Clinical Operations

BBOT; United States; Remote; USD 180,000 - 240,000; Full time

Benefits offered by this job

Equity participation

Competitive salary

Job summary

BridgeBio Oncology Therapeutics seeks a Director of Development and Clinical Operations to lead hands-on clinical trial execution and development operations. You will manage study timelines, vendor coordination, TMF quality, and budget tracking in a global, fast-paced biotech setting.

The role combines operational leadership with process improvements, requiring 10+ years in clinical operations and strong GCP compliance expertise. Remote nationwide work options are available.

Qualifications

• Bachelor's degree in life sciences, business, or related field.
• Minimum 10 years of experience in clinical operations or development operations with hands-on trial execution.
• Demonstrated experience as a clinical operations lead on early-phase oncology trials with ownership of timelines and vendor coordination.
• Experience supporting trial budget tracking, accruals, and financial review processes with proficiency in Excel and tracking tools (e.g., Smartsheet).
• Ability to develop or improve operational tools, templates, and process documentation in cross-functional environments.
• Strong knowledge of ICH-GCP, GCP compliance requirements, and regulatory standards.
• Excellent organizational, communication, and problem-solving skills; able to manage multiple workstreams in a lean biotech environment.
• Proficiency in clinical trial systems (EDC, CTMS, eTMF) and Microsoft Office Suite.
• Prior lean/startup biotech experience is highly desirable.

Responsibilities

• Provide program-level delivery oversight for assigned early-phase oncology studies.
• Serve as a senior clinical operations resource supporting CRO, vendor, and site-level activities.
• Participate in cross-functional study team meetings and manage deliverable tracking.
• Support inspection readiness and TMF quality for assigned programs.
• Provide operational support across CRO, vendor, and site activities, including study documents review.
• Contribute to SOPs and process improvements in clinical operations.

Skills

Clinical operations leadership

GCP compliance knowledge

Cross-functional collaboration

EDC/CTMS/eTMF proficiency

Education

Bachelor's degree in life sciences

Tools

EDC

CTMS

eTMF

Smartsheet

Job description

All Jobs > Director, Development and Clinical Operations

Director, Development and Clinical Operations
Fully Remote Remote - Nationwide

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.

Who You Are

We are seeking a Director, Development and Clinical Operations to fill a unique dual-focus role at BBOT, combining hands-on clinical trial execution with broader development operations responsibilities. Reporting to the VP, Development Operations, this individual will serve as the operational lead for assigned studies while also supporting the development organization through financial tracking, budget management, and process improvement initiatives. This role is well-suited for a clinical operations professional who is equally comfortable running trials and building the operational infrastructure that makes them run better. Global trial experience is required.

Responsibilities

Clinical Trial Operations and Study Delivery

• Provide program-level delivery oversight for assigned early-phase oncology studies, ensuring programs are on track against key milestones, timelines, and quality standards in coordination with the designated Global Study Lead and clinical operations point of contact
• Serve as a senior clinical operations resource for assigned programs, supporting CRO, vendor, and site-level activities as needed; contribute to study team discussions and decision-making with cross-functional program perspective
• Participate in cross-functional study team meetings for assigned programs; contribute to tracking of key deliverables and timelines, and help surface and elevate risks or issues to the VP, Development Operations or program lead
• Support inspection readiness and TMF quality for assigned programs in partnership with the study team; contribute to audit readiness activities and ensure study documentation standards are maintained
• Provide operational support across CRO, vendor, and site-level activities as needed, including contributing to review of study documents, tracking tools, monitoring plans, and study manuals for assigned programs
• Contribute to GCP compliance and SOP adherence across assigned clinical activities; support continuous improvement of clinical operations processes in collaboration with the broader Clinical Operations team

Financial Tracking and Budget Support

• Support monthly and quarterly financial reviews across assigned development programs by maintaining accurate and current budget trackers, purchase order logs, accrual schedules, and spend forecasts for outsourced and internal activities
• Review and process vendor invoices for assigned studies, verifying charges against executed contracts and actual deliverables; identify and resolve discrepancies in a timely manner in partnership with Finance and the Development Business Operations function
• Contribute to clinical trial budget development at the program level by providing operational cost inputs, tracking actuals against plan, and flagging variances to senior leadership
• Maintain study-level financial tracking tools and trackers; support portfolio-level budget reporting by ensuring assigned program data is current, accurate, and consistently formatted

Process Improvement and Operational Excellence

• Identify opportunities to improve clinical operations processes and workflows across assigned studies and the broader development organization; contribute to or lead implementation of practical process improvements that increase efficiency and consistency
• Help develop, maintain, and improve operational tools, templates, and reference documents for use across the Clinical Operations and Development teams, including tracking tools, meeting frameworks, and study start-up materials
• Contribute to the development and maintenance of SOPs, work instructions, and process guides for clinical operations activities; support inspection readiness by ensuring operational documentation is current and well-organized
• Participate in cross-functional working groups and operational cadences that support development organization efficiency; contribute to onboarding of new vendors, CROs, or team members as needed

Requirements

Education and Qualifications

• Bachelor's degree in life sciences, business, or a related field
• Minimum 10 years of experience in clinical operations, development operations, or a related function in a pharmaceutical or biotechnology setting, with direct hands‑on experience managing clinical trial execution
• Demonstrated experience as a clinical operations lead or CTM on early-phase oncology trials, with ownership of study timelines, site management, vendor coordination, and TMF quality
• Experience supporting clinical trial budget tracking, accruals, and financial review processes, with proficiency in Excel and operational tracking tools (e.g., Smartsheet)
• Demonstrated ability to develop or improve operational tools, templates, and process documentation in a cross-functional environment
• Strong working knowledge of ICH‑GCP, GCP compliance requirements, and clinical trial regulatory standards
• Excellent organizational, communication, and problem-solving skills; comfortable managing multiple concurrent workstreams in a fast-paced, lean biotech environment
• Proficient in clinical trial systems (e.g., EDC, CTMS, eTMF) and Microsoft Office Suite
• Prior experience in a lean or startup biotech environment is highly desirable

Why Join Us?

• Join a fast-paced, mission-driven biotech team focused on delivering transformational therapies
• Competitive salary, benefits, and meaningful equity participation in a company entering the public market