We are seeking a
Director or Senior Director, Translational Medicine to serve as BBOT's embedded translational medicine lead across its early-phase oncology programs, with a primary focus on RAS and PI3K-driven malignancies. Reporting to the CMO/CDO, this scientist will own translational and biomarker strategies from IND-enabling studies through proof of concept, operating at the intersection of biology, clinical data, and regulatory science. This is a hands-on, execution-oriented role for a deep expert in translational oncology who is energized by the pace and impact of a lean, early-stage biotech. Level of appointment will be commensurate with experience.
Requirements
ResponsibilitiesTranslational Strategy and Program Leadership - Serve as the dedicated translational medicine lead for assigned BBOT programs, defining and owning biomarker and translational strategies, plans, and decision-enabling datasets from preclinical through Phase 1/proof-of-concept
- Provide scientific input into target validation, pharmacology, PK/PD, target engagement, mechanism of action, and patient selection strategies; integrate preclinical findings with clinical development plans to inform dose selection, biomarker endpoints, and go/no-go criteria
- Evaluate emerging data from ongoing studies to generate and test hypotheses, define mechanisms of resistance, and adapt translational strategies in real time to support program advancement and reverse translation efforts
- Serve as the primary translational interface on cross-functional program teams, representing translational perspectives in clinical project teams, program governance, and portfolio reviews; translate complex biomarker evidence into clear risk/benefit and go-to-clinic recommendations
Biomarker Development and Clinical Implementation - Design, develop, and oversee hypothesis-driven biomarker plans including assay strategy (fit-for-purpose), sample collection and handling procedures, and statistical/analysis plans; lead assay selection, qualification/validation strategy, and oversight via internal or external partners
- Oversee clinical biomarker implementation: sample collection strategies, laboratory manuals, biomarker sections of clinical study protocols, informed consent forms, and analysis plans for first-in-human and early-phase studies
- Partner with clinical operations and external CROs, academic labs, and diagnostic partners to ensure robust sample logistics, data generation, documentation, and regulatory/quality readiness of all biomarker deliverables; oversee junior biomarker operations employees as assigned
- Ensure biomarker data and outputs meet quality standards for inclusion in clinical study reports, regulatory filings (INDs, briefing packages, NDAs), and scientific publications; serve as subject matter expert in health authority interactions involving translational and biomarker content
- Identify and incorporate emerging biomarker technologies and scientific advances into BBOT's translational approaches, including ctDNA/liquid biopsy, NGS, IHC/IF, and multi-omic platforms; engage external scientific collaborators and technology partners as needed
Scientific Communication and Team Contribution - Prepare and present translational updates, data reviews, biomarker sections of protocols and investigator brochures, and recommendations to development teams and senior management
- Contribute to resource planning, budgets, and timelines for translational and biomarker activities; manage vendor scopes and deliverables for outsourced translational work
- Represent BBOT at scientific conferences, investigator meetings, and key opinion leader engagements; contribute to publications and external scientific communications relevant to BBOT's programs
RequirementsEducation and Qualifications - Director, Translational Medicine - Ph.D., M.D., or M.D./Ph.D. in oncology, molecular biology, pharmacology, or a related field
- Minimum 7 years of experience in translational medicine, biomarker science, or oncology drug development in the pharmaceutical or biotechnology industry
- Proven track record of designing and executing translational biomarker strategies in early-phase oncology trials, including pharmacodynamic, predictive, and resistance biomarkers, assay development, and clinical deployment
- Solid understanding of RAS, PI3K, or related oncogenic signaling pathways; experience with small molecule targeted therapies strongly preferred
- Hands-on experience with biomarker platforms including NGS, ctDNA/liquid biopsy, IHC/IF, flow cytometry, or equivalent; experience with CRO/vendor management for biomarker assay execution
- Experience contributing to regulatory documents (INDs, briefing packages, clinical study reports) involving biomarker or translational content
- Strong cross-functional collaboration skills; ability to communicate complex scientific concepts clearly to non-specialist audiences and senior stakeholders
- Prior experience in a lean or startup biotech environment is highly desirable
Education and Qualifications - Senior Director, Translational Medicine - Ph.D., M.D., or M.D./Ph.D. in oncology, molecular biology, pharmacology, or a related field
- Minimum 10-12 years of experience in translational medicine, biomarker science, or oncology drug development, with a strong record of independent program ownership
- Demonstrated ability to independently lead translational medicine strategy across multiple programs simultaneously, from IND-enabling research through clinical proof of concept
- Deep expertise in translational biomarker strategy and execution, including assay validation, clinical deployment, CDx pathway considerations, and regulatory interactions involving biomarker-rich submissions
- In-depth knowledge of RAS/PI3K pathways, resistance mechanisms, and the evolving precision oncology landscape; experience with combination strategies and biomarker-driven indication expansion
- Advanced experience with genomic, molecular, and multi-omic profiling platforms; ability to integrate large, complex datasets to generate actionable translational insights
- Proven scientific communication skills including publications, conference presentations, and regulatory/KOL engagement; demonstrated ability to directly manage and/or mentor junior scientists and elevate team scientific capability
- Prior experience in a lean, startup, or high-growth biotech environment is highly desirable; comfort operating with high ambiguity and limited infrastructure
Salary Description
$235,000 - $310,000
