Director – Translational Medicine

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

📋 Description

• Act as the primary translational medicine lead for designated BBOT programs.

• Establish and oversee biomarker and translational strategies from preclinical phases through Phase 1/proof of concept.

• Offer scientific insights into target validation, pharmacology, PK/PD, target engagement, mechanism of action, and patient selection strategies.

• Combine preclinical findings with clinical development plans to guide dose selection, biomarker endpoints, and go/no-go criteria.

• Assess emerging study data, formulate and evaluate hypotheses, identify resistance mechanisms, and modify translational strategies accordingly.

• Represent translational viewpoints in cross-functional program teams, clinical project teams, program governance, and portfolio assessments.

• Design, develop, and manage hypothesis-driven biomarker plans, assay strategies, sample procedures, and statistical/analysis plans.

• Lead the selection, qualification, and validation strategy for assays, overseeing processes through internal or external partners.

• Supervise clinical biomarker implementation for first-in-human and early-phase studies.

• Collaborate with clinical operations, CROs, academic laboratories, and diagnostic partners on sample logistics, data generation, documentation, and regulatory/quality preparedness.

• Manage junior biomarker operations staff as assigned.

• Ensure that biomarker data meets quality standards for clinical study reports, regulatory submissions, and scientific publications.

• Act as a subject matter expert in health authority interactions regarding translational and biomarker content.

• Integrate ctDNA/liquid biopsy, NGS, IHC/IF, and multi-omic technologies into translational methodologies.

• Prepare and deliver translational updates, data evaluations, protocol sections, investigator brochures, and recommendations.

• Participate in resource planning, budgeting, and timelines; oversee vendor scopes and deliverables.

• Represent BBOT at scientific conferences, investigator meetings, and key opinion leader interactions.

• Contribute to publications and external scientific communications.

⛳️ Requirements

• Ph.D., M.D., or M.D./Ph.D. in oncology, molecular biology, pharmacology, or a related discipline.

• For Director: at least 7 years of experience in translational medicine, biomarker science, or oncology drug development within the pharmaceutical or biotechnology sector.

• For Senior Director: minimum of 10–12 years of experience in translational medicine, biomarker science, or oncology drug development, demonstrating a strong record of independent program leadership.

• Proven success in designing and implementing translational biomarker strategies in early-phase oncology trials.

• Strong understanding of RAS, PI3K, or similar oncogenic signaling pathways.

• Practical experience with NGS, ctDNA/liquid biopsy, IHC/IF, flow cytometry, or comparable biomarker platforms.

• Experience managing CROs/vendors for biomarker assay execution.

• Background in contributing to regulatory documents pertaining to biomarker or translational content.

• Ability to articulate complex scientific concepts clearly to non-specialist audiences and senior stakeholders.

• For Senior Director: capacity to independently guide translational medicine strategy across multiple programs concurrently.

• For Senior Director: expertise in assay validation, clinical deployment, CDx pathway considerations, and regulatory interactions.

• For Senior Director: extensive experience with genomic, molecular, and multi-omic profiling platforms.

• For Senior Director: skill in integrating large, complex datasets into actionable translational insights.

• For Senior Director: a track record of publications, conference presentations, and regulatory/KOL engagement.

• Previous experience in a lean, startup, or high-growth biotech setting is highly preferred.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holiday leave.

• Opportunities for professional development and continuous learning.

• Collaborative and innovative work environment.