Director, Clinical Scientist

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

📋 Description

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

• Participate in or oversee the initiation of studies, site activation, enrollment, medical monitoring, data cleaning, data analysis, and the writing of clinical study reports.

• Draft, review, and uphold study protocols, protocol amendments, investigator brochures, informed consent documents, 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 schemes, and stopping rules.

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

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

• Contribute to clinical development plans, contingency strategies, and program direction.

• Provide technical and scientific input to achieve program milestones and adhere to budgets.

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

• Incorporate emerging clinical data to guide ongoing study strategies and reverse translation.

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

• Represent BBOT at scientific conferences and investigator meetings.

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

• Aid in maintaining audit and inspection readiness.

• Collaborate across functions with Clinical Operations, Regulatory Affairs, Clinical Pharmacology, Translational Medicine, Biostatistics, and Safety.

⛳️ Requirements

• Ph.D. or Pharm.D. in a relevant scientific or clinical discipline, accompanied by a minimum of 3 years of oncology clinical development experience within a pharmaceutical or biotechnology industry setting.

• Alternatively, other related scientific or clinical degrees with 5-8 years of oncology clinical development experience in the pharmaceutical or biotechnology sector, or an M.D. with clinical development experience, will also be considered.

• Proficient experience in all facets of protocol conduct in early-phase oncology, including writing protocols, study initiation, execution, data analysis, and reporting.

• Proven ability to collaborate across various functions, including Clinical Operations, Regulatory Affairs, Translational Medicine, and Clinical Pharmacology.

• Strong written and verbal communication capabilities.

• Experience in creating clinical documents, such as protocols, investigator brochures, and clinical study reports.

• Experience in presenting data to both internal and external audiences.

• Solid analytical abilities and critical thinking skills.

• Capacity to interpret and synthesize complex clinical data and convert findings into clear, actionable recommendations.

• Established track record of achieving results within tight timelines.

• Ability to prioritize tasks while maintaining high-performance standards and meticulous attention to detail.

• Strong commitment to enhancing patients' lives and a passion for developing innovative oncology therapeutics.

• Willingness to thrive in a fast-paced, high-accountability, small-company environment.

• A collegial professional who leads through influence and possesses strong interpersonal skills.

• Intellectual curiosity and the initiative to challenge assumptions and discover new solutions to complex challenges.

• Prior experience in a lean or startup biotech environment is highly desirable.

• Willingness and ability to travel domestically and internationally for scientific conferences and clinical study site visits as required.

• Knowledge of compliance with ICH-GCP, applicable regulatory guidelines, and BBOT SOPs.

🏝️ Benefits

• Annual performance bonus.

• Company equity.

• Comprehensive health benefits.

• Market-competitive total rewards package.