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. Qualifications: 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. Technical/Skills: 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. Preferred Experience: 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). Benefits: 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. #J-18808-Ljbffr Scorpion Therapeutics