Clinical Scientist, Neuroimmunology & Specialty Care, PDT
Takeda
June 27, 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 new therapeutic approaches for people with rare and complex diseases.
- Work within the Neuroimmunology and Specialty Care team to develop clinical assets across the US, EU, and Japan (protocol concept/development, study start-up/execution, data cleaning, clinical study reports, and regulatory filing contributions).
- Integrate medical, scientific, regulatory, and commercial perspectives to support regulatory approval and clinical use of immunoglobulin products.
POSITION ACCOUNTABILITIES:
- Develop and execute clinical trials across the portfolio; contribute/represent clinical science with study clinical lead.
- Support protocol concept; write protocols; develop/coordinate protocol amendments.
- Develop key clinical documents (Investigator’s Brochure, CRFs, 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 submissions (IND/NDA clinical sections).
- Support study start-up/execution (site interactions, monitoring plans, data quality, issue resolution).
- Collaborate with clinical operations, biostatistics, regulatory, and medical affairs.
- Prepare budgets/forecasts, timelines, and project status reports.
- Design/recommend recruitment and feasibility strategies.
- Prepare literature reviews; present clinical data internally and to investigators.
- Provide immunoglobulin scientific support; lead training sessions.
- Mentor junior staff; review deliverables; improve trial systems (CTMS, eDC).
QUALIFICATIONS:
- Master’s or advanced degree (PharmD, DVM, or PhD) or equivalent.
- 5+ years clinical development experience (clinical trials).
- GCP and ICH guideline knowledge.
- Experience in neuroimmunology/hematology/immunology or related specialty areas.
- Experience preparing protocols, CSR/integrated statistical reports, and regulatory clinical sections (IND/NDA).
- Clinical trial operations experience (start-up, monitoring, data cleaning, quality oversight).
- CTMS/eDC experience; familiarity with CRF design.
- Budget/timeline/status report and clinical supply forecasting experience.
- Recruitment/site engagement and feasibility assessment capability.
- Ability to lead/influence multidisciplinary, multi-regional teams.
- Strong communication; experience presenting/training.
- Comfort with digital/AI tools where permitted.
- Inclusive, collaborative working style.
This role is hybrid per Takeda’s Hybrid and Remote Work policy.
APPLICATION INSTRUCTIONS:
- Apply via Takeda’s “Apply” button (acknowledging Privacy Notice/Terms of Use).
- Support Plasma-Derived Therapies R&D in advancing new therapeutic approaches for people with rare and complex diseases.
- Work within the Neuroimmunology and Specialty Care team to develop clinical assets across the US, EU, and Japan (protocol concept/development, study start-up/execution, data cleaning, clinical study reports, and regulatory filing contributions).
- Integrate medical, scientific, regulatory, and commercial perspectives to support regulatory approval and clinical use of immunoglobulin products.
POSITION ACCOUNTABILITIES:
- Develop and execute clinical trials across the portfolio; contribute/represent clinical science with study clinical lead.
- Support protocol concept; write protocols; develop/coordinate protocol amendments.
- Develop key clinical documents (Investigator’s Brochure, CRFs, 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 submissions (IND/NDA clinical sections).
- Support study start-up/execution (site interactions, monitoring plans, data quality, issue resolution).
- Collaborate with clinical operations, biostatistics, regulatory, and medical affairs.
- Prepare budgets/forecasts, timelines, and project status reports.
- Design/recommend recruitment and feasibility strategies.
- Prepare literature reviews; present clinical data internally and to investigators.
- Provide immunoglobulin scientific support; lead training sessions.
- Mentor junior staff; review deliverables; improve trial systems (CTMS, eDC).
QUALIFICATIONS:
- Master’s or advanced degree (PharmD, DVM, or PhD) or equivalent.
- 5+ years clinical development experience (clinical trials).
- GCP and ICH guideline knowledge.
- Experience in neuroimmunology/hematology/immunology or related specialty areas.
- Experience preparing protocols, CSR/integrated statistical reports, and regulatory clinical sections (IND/NDA).
- Clinical trial operations experience (start-up, monitoring, data cleaning, quality oversight).
- CTMS/eDC experience; familiarity with CRF design.
- Budget/timeline/status report and clinical supply forecasting experience.
- Recruitment/site engagement and feasibility assessment capability.
- Ability to lead/influence multidisciplinary, multi-regional teams.
- Strong communication; experience presenting/training.
- Comfort with digital/AI tools where permitted.
- Inclusive, collaborative working style.
This role is hybrid per Takeda’s Hybrid and Remote Work policy.
APPLICATION INSTRUCTIONS:
- Apply via Takeda’s “Apply” button (acknowledging Privacy Notice/Terms of Use).