Director, Clinical Scientist

Paylocity; Northern (KY); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Equity

Health benefits

Annual performance bonus

Job summary

BBOT, a clinical-stage biopharmaceutical company, seeks a Director-level Clinical Scientist to lead medical and scientific oversight of early-phase oncology studies (FIH and Phase 1). You will report to the Senior Medical Director and work across Clinical Operations, Regulatory Affairs, and Clinical Pharmacology to design, monitor, and report studies that advance BBOT’s mission.

You will translate preclinical findings to clinical development hypotheses, interact with investigators, and ensure

Qualifications

• Ph.D. or Pharm.D. required with oncology clinical development experience (3+ years); or MD with clinical development experience.
• Experience across protocol conduct in early-phase oncology: protocol writing, start-up, execution, data analysis, reporting.
• Strong written and oral communication skills and ability to present data to diverse audiences.

Responsibilities

• Support the Medical Monitor or serve as clinical lead for Phase 1a/1b studies and future programs; contribute to study start-up, site activation, enrollment, monitoring, data cleaning, analyses, CSR writing
• Author, review, and maintain key clinical documents (protocols, amendments, IBs, ICFs, CSRs)
• Partner with investigators and CROs to design and implement studies; provide input on design, endpoints, inclusion/exclusion, dose escalation, stopping rules
• Conduct investigator meetings and site initiation visits; serve as primary medical contact for sites and study teams
• Contribute to development and execution of clinical development plans, contingency plans, and program strategy; advise on milestones and budgets
• Translate preclinical findings into clinical hypotheses; integrate new data to refine strategy
• Represent BBOT at scientific conferences and investigator meetings; interact with investigators and thought leaders
• Ensure all activities comply with ICH-GCP and regulatory guidelines; support audit readiness
• Collaborate with Clinical Operations, Regulatory Affairs, Clinical Pharmacology, Translational Medicine, Biostatistics, and Safety for integrated execution

Skills

Clinical development

Oncology

Communication

Collaboration

Data analysis

Education

Ph.D. or Pharm.D.

M.D. with clinical development experience

Job description

BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information visit BBOTx.com.

Who You Are

We are seeking a Director-level Clinical Scientist with a proven track record in oncology clinical development to join BBOT’s growing clinical team. Reporting to the Senior Medical Director, Clinical Development, this role will have primary responsibility for the medical and scientific aspects of assigned clinical studies across BBOT’s early-phase oncology pipeline, with an emphasis on first-in-human (FIH) and Phase 1 programs in RAS- and PI3K-driven solid tumors. The Clinical Scientist will work collaboratively across multidisciplinary teams—including Clinical Operations, Regulatory Affairs, and Clinical Pharmacology—to design, implement, monitor, and report studies that advance BBOT’s mission to deliver transformative therapies to patients. This is a high-impact, visible role that actively contributes to BBOT’s dynamic and innovative culture.

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

Requirements

Education and Qualifications

• 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


• Ability and willingness to travel domestically and internationally to attend scientific conferences and clinical study sites as needed

WHAT WE OFFER

At BBOT, we strive to provide a market-competitive total rewards package, including base pay, annual performance bonus, company equity, and comprehensive health benefits. The final compensation package will depend on factors including experience, skills, education, location, and performance throughout the interview process.