Clinical Scientist, Neuroimmunology & Specialty Care, PDT
Takeda
August 30, 2026
Remote friendly (Boston, MA)
United States
$116,000 - $182,270 USD yearly
Clinical Research and Development
Position Objectives:
- Support Plasma-Derived Therapies R&D in advancing therapeutic approaches for rare/complex diseases within Neuroimmunology and Specialty Care.
- Work across US/EU/Japan to support clinical asset development: protocol concept/development, study start-up/execution, data cleaning, clinical study report preparation, and contributions to regulatory filings.
Position Accountabilities:
- Contribute to/represent clinical science in development and execution of clinical trials.
- Develop protocol documents; coordinate protocol amendments/updates.
- Coordinate trial documents (Investigator’s Brochure, case report forms, informed consent forms, clinical development plan).
- Lead/contribute to data cleaning and preparation of integrated clinical statistical final study reports and clinical study reports; support regulatory submission clinical sections (IND/NDA).
- Support study start-up/execution (site interactions, monitoring plans, data quality, issue resolution).
- Collaborate with clinical operations, biostatistics, regulatory affairs, and medical affairs.
- Support budgets/forecasts, clinical timelines, and project status reports.
- Advise on recruitment strategies and feasibility assessments.
- Prepare literature reviews and present clinical data.
- Provide immunoglobulin-related scientific support and lead trainings.
- Mentor junior staff; review deliverables; improve trial systems (CTMS, electronic data capture).
Qualifications / Skills:
- Master’s or advanced degree (PharmD, DVM, or PhD) or equivalent; 5+ years clinical development experience.
- GCP and ICH knowledge applied to trial design/conduct.
- Neuroimmunology/hematology/immunology (or relevant specialty) experience.
- Protocols/CSRs/integrated statistical reports and regulatory clinical sections across regions (IND/NDA).
- Clinical trial operations: start-up, monitoring, data cleaning, quality oversight.
- Clinical trial systems (CTMS, EDC); case report form familiarity.
- Budget/timeline/status reporting; clinical supply forecasting.
- Recruitment/site strategy and feasibility for rare/complex studies.
- Ability to lead/influence multidisciplinary, multi-regional teams; strong scientific/clinical/regulatory communication.
- Comfort using digital/AI tools where permitted.
- Inclusive, collaborative working style.
Application instructions:
- Apply via the “Apply” button.
- Support Plasma-Derived Therapies R&D in advancing therapeutic approaches for rare/complex diseases within Neuroimmunology and Specialty Care.
- Work across US/EU/Japan to support clinical asset development: protocol concept/development, study start-up/execution, data cleaning, clinical study report preparation, and contributions to regulatory filings.
Position Accountabilities:
- Contribute to/represent clinical science in development and execution of clinical trials.
- Develop protocol documents; coordinate protocol amendments/updates.
- Coordinate trial documents (Investigator’s Brochure, case report forms, informed consent forms, clinical development plan).
- Lead/contribute to data cleaning and preparation of integrated clinical statistical final study reports and clinical study reports; support regulatory submission clinical sections (IND/NDA).
- Support study start-up/execution (site interactions, monitoring plans, data quality, issue resolution).
- Collaborate with clinical operations, biostatistics, regulatory affairs, and medical affairs.
- Support budgets/forecasts, clinical timelines, and project status reports.
- Advise on recruitment strategies and feasibility assessments.
- Prepare literature reviews and present clinical data.
- Provide immunoglobulin-related scientific support and lead trainings.
- Mentor junior staff; review deliverables; improve trial systems (CTMS, electronic data capture).
Qualifications / Skills:
- Master’s or advanced degree (PharmD, DVM, or PhD) or equivalent; 5+ years clinical development experience.
- GCP and ICH knowledge applied to trial design/conduct.
- Neuroimmunology/hematology/immunology (or relevant specialty) experience.
- Protocols/CSRs/integrated statistical reports and regulatory clinical sections across regions (IND/NDA).
- Clinical trial operations: start-up, monitoring, data cleaning, quality oversight.
- Clinical trial systems (CTMS, EDC); case report form familiarity.
- Budget/timeline/status reporting; clinical supply forecasting.
- Recruitment/site strategy and feasibility for rare/complex studies.
- Ability to lead/influence multidisciplinary, multi-regional teams; strong scientific/clinical/regulatory communication.
- Comfort using digital/AI tools where permitted.
- Inclusive, collaborative working style.
Application instructions:
- Apply via the “Apply” button.