Associate Director, Translational Sciences

Role Summary

We are seeking an experienced Associate Director of Translational Sciences to lead translational and biomarker efforts across early-phase clinical trials for cell-based therapies, with a focus on Type 1 Diabetes (T1D) and CAR-T cell programs. This role develops and executes clinical translational strategies, oversees assay development and validation for treated patient samples, and ensures high-quality biomarker data to support early clinical decision-making. Reporting to the Head of Immunology and Translational Sciences, the role collaborates with the Early Clinical Development team, Computational Biology, and external CRO partners to ensure translational readiness and scientific rigor across first-in-human and early-phase trials. The role includes direct management of a small team of translational scientists, while maintaining hands-on ownership of translational strategy and execution.

Responsibilities

• Clinical Translational Strategy
  • Develop and execute translational and biomarker strategies to support early clinical trials.
  • Define clinical biomarker objectives, context of use, and analysis plans aligned with program mechanisms of action.
  • Partner with Development and Clinical Operations to ensure biomarker integration into clinical protocols, sample collection plans, and trial timelines.
  • Enable clinical decision-making through data-driven interpretation of patient-derived translational datasets.
• Clinical Assay Development & Validation
  • Lead the development, qualification, and validation of translational assays for treated patient samples.
  • Oversee assays including (but not limited to):
  • Immune phenotyping (flow cytometry)
  • Cytokine and soluble biomarker assays
  • Functional immune and cell therapy–related assays
  • ADA-related assays
  • Molecular biomarkers relevant to T1D and CAR-T therapies
  • Ensure assays are fit-for-purpose, robust, and compliant with GCP/GLP expectations for clinical trials.
• CRO & Vendor Management
  • Serve as the primary scientific lead for clinical biomarker and translational CROs.
  • Lead CRO selection, scope definition, assay transfer, and ongoing oversight.
  • Manage CRO communications, timelines, and deliverables to ensure high-quality, interpretable clinical data.
  • Critically review CRO-generated data and reports, identifying trends, limitations, and implications for clinical programs.
• Data Integration, Interpretation & Communication
  • Partner closely with Computational Biology and Data Science team to define translational data pipelines, support analysis and visualization of clinical biomarker datasets, and ensure high-quality, integrated interpretation that informs program strategy and clinical development decisions.
  • Present translational findings to internal program teams, governance committees, and senior leadership.
  • Contribute to clinical study reports, regulatory documents, and external scientific communications as needed.
• Team Leadership & Development
  • Lead, mentor, and develop a small team of translational scientists, providing scientific direction, prioritization, and performance feedback to ensure high-quality execution across programs.
  • Balance people management responsibilities with direct ownership of translational strategy, CRO oversight, and cross-functional leadership.

Qualifications

• Required: 8+ years of relevant industry experience in clinical translational science, biomarker development, or bioanalysis, with a strong focus on early clinical development.
• Required: Demonstrated experience supporting clinical trials using patient-derived samples.
• Preferred: Prior experience in Type 1 Diabetes (T1D) and CAR-T cell or other cell therapy programs.

Education

• PhD or other advanced degree in Immunology, Translational Medicine, Cell & Gene Therapy, or a related field.

Skills

• Deep understanding of clinical biomarker development, immune monitoring, and translational data interpretation in a clinical trial setting.
• Hands-on experience with clinical assay development, qualification, and validation, including execution through external CROs.
• Strong working knowledge of GCP, GLP, and regulatory expectations for clinical biomarker data.
• Proven ability to work effectively in a cross-functional, matrixed environment, partnering with development, operations, regulatory, and computational teams.
• Strong experience managing external CROs and vendors, including scientific oversight and data review.
• Excellent written and verbal communication skills, with the ability to translate complex clinical biomarker data into clear, actionable insights.