Associate Director, Translational Sciences
Scorpion Therapeutics, Watertown, Massachusetts, us, 02472
Role Summary
Lead translational sciences for early-phase cell therapy programs with a focus on Type 1 Diabetes (T1D) and CAR-T cell therapies. Develop and execute clinical translational strategies, own oversight of assay development and validation for treated patient samples, and ensure high-quality biomarker data to support early clinical decision-making. Report to the Head of Immunology and Translational Sciences, collaborating with the Early Clinical Development team, Computational Biology, and external CROs to ensure translational readiness and scientific rigor across first-in-human and early-phase trials. This role includes direct management of a small team of translational scientists and 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 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
8+ years of relevant industry experience in clinical translational science, biomarker development, or bioanalysis, with a strong focus on early clinical development.
Demonstrated experience supporting clinical trials using patient-derived samples.
Prior experience in Type 1 Diabetes (T1D) and CAR-T cell or other cell therapy programs is strongly preferred.
Experience supporting first-in-human and/or early-phase cell therapy trials.
Familiarity with immune monitoring in autoimmune disease, including T1D, is a plus.
Experience contributing to INDs, protocol development, amendments, or regulatory responses from a translational science perspective.
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.
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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 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
8+ years of relevant industry experience in clinical translational science, biomarker development, or bioanalysis, with a strong focus on early clinical development.
Demonstrated experience supporting clinical trials using patient-derived samples.
Prior experience in Type 1 Diabetes (T1D) and CAR-T cell or other cell therapy programs is strongly preferred.
Experience supporting first-in-human and/or early-phase cell therapy trials.
Familiarity with immune monitoring in autoimmune disease, including T1D, is a plus.
Experience contributing to INDs, protocol development, amendments, or regulatory responses from a translational science perspective.
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.
#J-18808-Ljbffr