Senior Director Translational Science

A leading biotechnology company is seeking an experienced Senior Director/Executive Director, Head of Translational Research to join its Research & Development team. This role will lead the translational sciences group, driving biomarker strategies to support the development of an innovative pipeline.

Role Overview

The successful candidate will be responsible for designing, executing, and delivering translational biomarker strategies, including patient selection, pharmacodynamic endpoints, target engagement, and safety biomarkers. This role requires close collaboration with preclinical, CMC, and clinical development teams to define mechanisms of action and key product characteristics.

Key Responsibilities

• Lead the translational research team and provide support for pipeline development.
• Guide and mentor translational representatives in cross-functional teams, working closely with discovery, preclinical, CMC, and clinical teams.
• Develop and implement biomarker strategies aligned with clinical development objectives.
• Conduct translational safety investigations, establish mechanism-of-action hypotheses, and identify key product characteristics relevant to efficacy and treatment response.
• Support clinical and regulatory teams in preparing investigator brochures, IND applications, clinical protocols, and other regulatory documents.
• Oversee patient selection strategies and companion diagnostics (CDx) development, approval, and implementation.
• Manage collaborations with CROs and academic partners.

Requirements

• PhD or MD in biology, immunology, biochemistry, or a related field.
• Minimum 15 years of relevant experience, including at least 10 years in the pharmaceutical or biotech industry.
• Experience in cell or gene therapy clinical development preferred.
• Strong expertise in immunology and tumor biology.
• Deep understanding of clinical biomarker analysis, assay platforms, and research technologies.
• Excellent communication and scientific writing skills.
• Ability to work collaboratively across cross-functional teams.

This is an opportunity to make a significant impact in an innovative and fast-paced biotech environment. If you are a highly motivated leader with a passion for translational research, we encourage you to apply.