Director or Senior Director of Translational Medicine

Job Description

Job Description

Description:

About BridgeBio Oncology Therapeutics

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 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:

Responsibilities

Translational 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

Requirements

Education 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