Director, Clinical Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist the Medical Monitor or act as the clinical lead for designated Phase 1a/1b studies and upcoming late-stage programs.

• Participate in or supervise study initiation, site activation, enrollment, medical monitoring, data cleaning, data analysis, and clinical study report preparation.

• Write, review, and manage study protocols, protocol amendments, investigator brochures, informed consent forms, and clinical study reports.

• Collaborate with investigators and CROs to design and execute clinical studies.

• Offer scientific and medical insights into study design, endpoints, inclusion/exclusion criteria, dose escalation schemas, and stopping rules.

• Conduct investigator meetings, safety review committee gatherings, and site initiation visits.

• Act as the main medical contact for clinical site investigators and study teams.

• Contribute to clinical development plans, contingency plans, and overall program strategy.

• Provide technical and scientific guidance to achieve program milestones and manage budgets.

• Convert preclinical and non-clinical findings into clinical development hypotheses and opportunities.

• Integrate emerging clinical data to shape ongoing study strategies and reverse translation.

• Engage with clinical investigators, thought leaders, and cooperative groups.

• Represent BBOT at scientific conferences and investigator meetings.

• Ensure compliance of clinical trial activities with ICH-GCP, relevant regulatory guidelines, and BBOT SOPs.

• Assist in audit and inspection readiness.

• Collaborate across various functions, including Clinical Operations, Regulatory Affairs, Clinical Pharmacology, Translational Medicine, Biostatistics, and Safety for cohesive program execution.

⛳️ Requirements

• Ph.D. or Pharm.D. in a relevant scientific or clinical field, with a minimum of 3 years of oncology clinical development experience in the pharmaceutical or biotechnology industry.

• Other scientific or clinical degrees with at least 5-8 years of oncology clinical development experience in a pharmaceutical or biotechnology context, or an M.D. with clinical development experience will also be considered.

• Experience in all facets of protocol conduct in early-phase oncology, including protocol development, study initiation, execution, data analysis, and reporting.

• Ability to collaborate across various functions in a team-oriented environment, including Clinical Operations, Regulatory Affairs, Translational Medicine, and Clinical Pharmacology.

• Excellent written and verbal communication skills, with experience in drafting clinical documents (protocols, IBs, CSRs) and presenting data to both internal and external stakeholders.

• Strong analytical and critical thinking abilities; capable of interpreting and synthesizing complex clinical data and translating findings into clear, actionable recommendations.

• Proven track record of delivering results within tight timelines; adept at prioritizing tasks and maintaining high-performance standards and attention to detail.

• Deep dedication to enhancing patient lives and a passion for developing innovative therapeutics in oncology.

• Willingness to thrive in a fast-paced, high-accountability, small-company setting; demonstrating professionalism, interpersonal skills, intellectual curiosity, initiative, and the ability to challenge assumptions and identify new solutions to complex issues.

• Previous experience in a lean or startup biotech environment is highly preferred.

• Willingness to travel domestically and internationally to attend scientific conferences and clinical study sites as required.

• Adherence to ICH-GCP, applicable regulatory guidelines, and BBOT SOPs.

🏝️ Benefits

• Annual performance bonus.

• Company equity.

• Comprehensive health benefits.