Remote Position
[Remote] Director, Clinical Scientist
๐ Remote ยท United States
๐ผ Full-time
Note: The job is a remote job and is open to candidates in USA. BridgeBio Oncology Therapeutics (BBOT) is seeking a Director, Clinical Scientist to lead the medical and scientific aspects of assigned early-phase oncology studies, especially first-in-human and Phase 1 programs. The role supports study design and execution, clinical documents and data reporting, and cross-functional clinical development strategy for RAS- and PI3K-driven solid tumors.
Responsibilities
- Support the Medical Monitor or serve as clinical lead for assigned Phase 1a/1b studies and future late-stage programs, including contributing to or overseeing study start-up, site activation, enrollment, medical monitoring, data cleaning, data analyses, and clinical study report (CSR) writing
- Author, review, and maintain key clinical documents including study protocols, protocol amendments, investigator brochures (IBs), informed consent forms (ICFs), and clinical study reports
- Partner with investigators and CROs to design and implement clinical studies; provide scientific and medical input into study design, endpoints, inclusion/exclusion criteria, dose escalation schemas, and stopping rules
- Conduct investigator meetings, safety review committee meetings, and site initiation visits; serve as a primary medical point of contact for clinical site investigators and study teams
- Contribute to the development and execution of clinical development plans, contingency plans, and program strategy; provide technical and scientific input to meet program milestones and budgets
- Translate findings from preclinical and non-clinical studies into clinical development hypotheses and opportunities; integrate emerging clinical data to inform ongoing study strategy and reverse translation
- Interact with clinical investigators, thought leaders, and cooperative groups as appropriate; represent BBOT at scientific conferences and investigator meetings
- Ensure all clinical trial activities are conducted in accordance with ICH-GCP, applicable regulatory guidelines, and BBOT SOPs; support audit and inspection readiness
- Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, Clinical Pharmacology, Translational Medicine, Biostatistics, and Safety to ensure integrated and high-quality program execution
Skills
- Ph.D. or Pharm.D. in a relevant scientific or clinical discipline, with at least 3 years of oncology clinical development experience in a pharmaceutical or biotechnology industry setting; other related scientific or clinical degrees with at least 5-8 years of oncology clinical development experience in a pharmaceutical or biotechnology industry setting, or an M.D. with clinical development experience will also be considered
- Experience across all aspects of protocol conduct in early-phase oncology, including protocol writing, study start-up, execution, data analysis, and reporting
- Demonstrated ability to collaborate across multiple functions in a team environment, including Clinical Operations, Regulatory Affairs, Translational Medicine, and Clinical Pharmacology
- Strong written and oral communication skills, including experience writing clinical documents (protocols, IBs, CSRs) and presenting data to internal and external audiences
- Solid analytical and critical thinking skills; ability to interpret and synthesize complex clinical data and translate findings into clear, actionable recommendations
- Demonstrated record of delivering results in compressed timelines; capable of prioritizing tasks and maintaining high-performance standards and attention to detail
- Deep commitment to improving the lives of patients and a passion for developing novel therapeutics in oncology
- Motivated to work in a fast-paced, high-accountability, small-company environment; a collegial professional who leads through influence and strong interpersonal skills; intellectually curious, with the initiative to challenge assumptions and identify new approaches to complex problems
- Prior experience in a lean or startup biotech environment is highly desirable
Benefits
- Annual performance bonus
- Company equity
- Comprehensive health benefits
Company Overview
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