Clinical Scientist, Neuroimmunology & Specialty Care, PDT

Position Objectives

• Support the Neuroimmunology and Specialty Care team in advancing clinical assets for rare and complex diseases (US, EU, Japan), including protocol concept/development, study start-up/execution, data cleaning, clinical study report preparation, and contributions to regulatory filings.

• Contribute to and represent clinical science for development/execution of clinical trials.
• Develop protocols; coordinate protocol amendments/updates.
• Create trial-related documents (Investigator’s Brochure, case report forms, informed consent forms, clinical development plan).
• Lead/contribute to data cleaning and integrated clinical statistical final study reports; support clinical sections of regulatory submissions (IND/NDA).
• Support study start-up/execution (site interactions, monitoring plans, data quality, issue resolution).
• Collaborate with clinical operations, biostatistics, regulatory, and medical affairs.
• Support clinical budgets/forecasts, timelines, and status reports.
• Advise on recruitment strategies and feasibility.
• Conduct literature reviews; present clinical data.
• Provide immunoglobulin product scientific support; lead training; mentor junior staff and improve trial systems (CTMS, EDC).

• MS/advanced degree (PharmD/DVM/PhD) or equivalent; 5+ years clinical development.
• GCP/ICH knowledge; experience in neuroimmunology/hematology/immunology or relevant specialty.
• Proven protocol/CSR/integrated statistical report and regulatory section (IND/NDA) experience across regions.
• Trial operations experience (start-up, monitoring, data cleaning, quality, issue resolution).
• CTMS/EDC and case report form familiarity.
• Budget/timeline/status report and clinical supply forecasting experience.
• Recruitment/site engagement strategy and feasibility assessment ability.
• Clear communication; ability to lead/influence multidisciplinary multi-regional teams.
• Comfort using digital/AI-enabled tools (where permitted).
• Inclusive, collaborative mindset.

• Hybrid.

• US base salary range: $–$; may be eligible for incentives and benefits including medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time, and paid vacation.