Clinical Scientist, Neuroimmunology & Specialty Care, PDT
Takeda
August 09, 2026
Remote friendly (Boston, MA)
United States
$116,000 - $182,270 USD yearly
Clinical Research and Development
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.
Position Accountabilities:
- 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).
Education/Qualifications & Skills:
- 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.
Work arrangement:
- Hybrid.
Compensation/Benefits:
- US base salary range: $116,000.00–$182,270.00; 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.
Application instructions:
- No Phone Calls or Recruiters Please.
- 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.
Position Accountabilities:
- 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).
Education/Qualifications & Skills:
- 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.
Work arrangement:
- Hybrid.
Compensation/Benefits:
- US base salary range: $116,000.00–$182,270.00; 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.
Application instructions:
- No Phone Calls or Recruiters Please.