Principal Scientist, Translational Medicine

About the Role As a key contributor to the clinical biomarker strategy, responsible for working with cross‑functional teams on planning, implementation, execution of clinical biomarker testing, and data delivery. Integrate scientific and operational expertise through cross‑functional partnerships, CRO management, strategic project planning, and facilitating key biomarker execution components of clinical trials. Your Contributions (Responsibilities) Collaborate with biomarker scientists and clinical teams to design biomarker strategies (assay platform selection, assay parameters, and protocols). Serve as assay SME in at least one technical area; guide CROs on biomarker validation, experimental design, troubleshooting, and method development. Maintain a network of specialty biomarker vendors; select best CROs and ensure quality standards/certification. Partner with scientific/clinical leads, procurement, contracting, and compliance to negotiate contracts, prepare SOWs, oversee execution status, and ensure deliverables meet requirements. Manage CRO relationships to ensure ethical, high‑quality biomarker data; meet development timelines while ensuring data quality/assay performance. Work with data management to establish data collection, reconciliation, and transfer specifications with CROs. Contribute to clinical documents (lab templates/manuals, informed consent, eCRF, sample/data management plan, early development plans, site training materials). When relevant, oversee collection/handling/storage/shipment of clinical trial samples to external labs. Apply/adhere to ICH/GCP, sample storage procedures, sample management best practices, and ethical guidelines. Maintain biomarker budgets (assay development/validation, in‑study testing, long‑term sample storage). Requirements 10+ years applicable experience/training OR BS/BA in Biology/Chemistry or related + 6+ years OR Master’s in Biology/Chemistry or related + 4+ years OR PharmD/PhD + 2+ years. Strong communication skills; proactive, innovative, strong problem‑solving/analytical skills. Ability to lead and/or work in teams; typically leads and trains junior staff. Working knowledge of FDA biomarker method validation guidance. Background in clinical biomarkers and commonly used methodologies. Deep expertise in at least one biomarker platform (neuroimaging, electrophysiology, or biofluid) and understanding of integrating other modalities. Experience with clinical study operations/clinical research strategic planning. Extensive CRO experience supporting assay development and sample testing. Regulatory filing/interactions experience. Experience in GLP/GMP and/or GCP regulated environments. Benefits Retirement savings plan (company match); paid vacation/holidays/personal days; paid caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision). Annual bonus target: 30% of earned base salary; eligibility for equity-based long‑term incentive. Annual base salary (expected): $130,800.00–$179,000.00. #J-18808-Ljbffr Scorpion Therapeutics