Director, Oncology Clinical Development

BBOT; United States; On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Annual bonus

Equity

Health benefits

Job summary

BBOT is seeking a Director-level Clinical Scientist to lead oncology clinical development for early-phase programs, including first-in-human and Phase 1 studies in RAS- and PI3K-driven solid tumors. You will drive study design, data interpretation, and cross-functional collaboration with Clinical Operations, Regulatory Affairs, and Translational Medicine.

You will translate preclinical findings into clinical hypotheses, oversee key clinical documents, and ensure trials adhere to ICH-GCP and

Qualifications

• Ph.D. or Pharm.D. in a relevant discipline with oncology clinical development experience.
• MD with clinical development experience considered.
• Experience across all aspects of protocol conduct in early-phase oncology, including protocol writing, start-up, execution, analysis, and reporting.

Responsibilities

• Support the Medical Monitor or serve as clinical lead for Phase 1a/1b studies; contribute to start-up, site activation, enrollment, monitoring, data cleaning, analyses, CSR writing.
• Author, review, and maintain key clinical documents including protocols, amendments, investigator brochures, informed consent forms, and CSR writing.
• Partner with investigators and CROs to design and implement studies; provide input on study design, endpoints, inclusion/exclusion, dose escalation, and stopping rules.
• Conduct investigator meetings, safety review committee meetings, and site initiation visits; serve as primary medical contact for site investigators and teams.
• Contribute to development and execution of clinical development plans, contingency plans, and program strategy; provide input to meet milestones and budgets.
• Translate findings from preclinical/non-clinical studies into clinical hypotheses and inform ongoing study strategy; reverse translation.

Skills

Oncology clinical development

Cross-functional collaboration

Scientific writing

Education

PhD or PharmD in relevant field

MD with clinical development experience

Job description

BBOT is seeking a Director-level Clinical Scientist to lead oncology clinical development for early-phase programs, including first-in-human and Phase 1 studies in RAS- and PI3K-driven solid tumors. You will drive study design, data interpretation, and cross-functional collaboration with Clinical Operations, Regulatory Affairs, and Translational Medicine.

You will translate preclinical findings into clinical hypotheses, oversee key clinical documents, and ensure trials adhere to ICH-GCP and