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Director, Clinical Scientist

Job not on LinkedIn

đź•’ Yesterday

🇺🇸 United States – Remote

đź’µ $225k - $265k / year

⏰ Full Time

đź”´ Lead

👨‍⚕️ Medical Director

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Logo of BBOT

BBOT

51 - 200 employees

🏥 Healthcare

đź’Ľ Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

BBOT is a biotechnology company developing targeted therapies for cancers driven by RAS signaling and PI3Kα. The company focuses on rational drug design to inhibit the active ON state of RAS and to selectively block RAS-driven PI3K activation, aiming at multiple KRAS mutants and novel approaches to maximize target inhibition. BBOT translates decades of RAS biology research into therapeutic candidates intended to improve outcomes for patients with RAS- and PI3Kα-driven tumors.

đź“‹ Description

• Support the Medical Monitor or serve as clinical lead for assigned Phase 1a/1b studies and future late-stage programs • Contribute to or oversee study start-up, site activation, enrollment, medical monitoring, data cleaning, data analyses, and clinical study report writing • Author, review, and maintain study protocols, protocol amendments, investigator brochures, informed consent forms, 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 clinical development plans, contingency plans, and program strategy • Provide technical and scientific input to meet program milestones and budgets • Translate preclinical and non-clinical findings 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 • Represent BBOT at scientific conferences and investigator meetings • Ensure clinical trial activities comply 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

🎯 Requirements

• 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, including Clinical Operations, Regulatory Affairs, Translational Medicine, and Clinical Pharmacology • Strong written and oral communication skills • Experience writing clinical documents, including protocols, IBs, and CSRs • Experience 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 • Ability to prioritize tasks and maintain high-performance standards and attention to detail • Deep commitment to improving patients' lives and passion for developing novel oncology therapeutics • Motivation to work in a fast-paced, high-accountability, small-company environment • Collegial professional who leads through influence and strong interpersonal skills • Intellectual curiosity and 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 • Compliance knowledge of ICH-GCP, applicable regulatory guidelines, and BBOT SOPs

🏖️ Benefits

• Annual performance bonus • Company equity • Comprehensive health benefits • Market-competitive total rewards package

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