Remote Director, Clinical Ops & Development

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

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.