Director, Translational Sciences

Responsibilities:

• Define and drive translational science strategy across the early clinical pipeline; ensure alignment with corporate objectives and clinical priorities.
• Primary scientific owner of translational strategy across T1D and CAR-T programs; integrate biomarker objectives into clinical protocols, sample collection plans, and trial timelines.
• Contribute to functional area strategy and company-level decision-making.
• Represent translational sciences internally and externally (conferences, regulatory agencies, academic/industry partners).
• Lead development and execution of translational and biomarker strategies for early-phase trials, including first-in-human studies.
• Define clinical biomarker objectives, context of use, and analysis plans aligned with mechanism of action and regulatory expectations.
• Interpret patient-derived translational datasets to inform program strategy.
• Partner with Early Development, Clinical Operations, Regulatory, and Medical to ensure translational readiness.
• Oversee assay development/qualification/validation for treated patient samples: immune phenotyping (flow), cytokine/soluble biomarkers, functional immune/cell-therapy assays, ADA assays, and molecular biomarkers (T1D/CAR-T).
• Ensure assays are fit-for-purpose and compliant with GCP/GLP expectations; set quality/scientific standards across internal/external labs.
• Define and lead clinical biomarker CRO strategy (partner selection, scope, assay transfer, governance); evaluate CRO data critically.
• Define translational data pipelines with Computational Biology/Data Science; drive integrated interpretation and communicate findings.
• Contribute to/lead clinical study reports, INDs, protocol amendments, and external scientific communications.
• Build and lead the Translational Sciences team; manage resources, headcount, and budget; attract and develop talent.

• PhD or advanced degree in Immunology, Translational Medicine, Cell & Gene Therapy, or related field.
• 10+ years industry experience in clinical translational science/biomarker development/bioanalysis with substantial early clinical leadership.
• Track record driving translational strategies through IND, first-in-human, and early-phase milestones.
• Strongly preferred: experience in T1D/autoimmune and/or CAR-T or other cell/gene therapy; prior team leadership/building.

• Expert knowledge of clinical biomarker development, immune monitoring, and translational data interpretation.
• Deep expertise in assay development/qualification/validation, including scale execution through CROs.
• Mastery of GCP/GLP and regulatory expectations for clinical biomarker data; experience contributing to regulatory filings.
• Strategic leadership with cross-functional matrix leadership; strong communication; sound scientific judgment under ambiguity.

• First-in-human cell/gene therapy translational science leadership.
• Immune monitoring in autoimmune disease (incl. T1D).
• Contributions to INDs, clinical protocol/regulatory amendments, or translational responses.
• External scientific contributions (publications, conferences, patents, regulatory interactions).

• Expected salary range: $195,000-$218,000.
• Annual performance-based bonus (prorated by start date).
• Medical, dental, vision insurance; 401K match; 20+ days PTO (prorated by start date).
• Employees not requiring sponsorship are preferred.