Clinical Scientist, Neuroimmunology & Specialty Care, PDT

About the role

Join us as a Clinical Scientist, Neuroimmunology & Specialty Care, PDT in our Cambridge, MA office. At Takeda, we transform the pharmaceutical industry through R&D-driven market leadership and values-led culture. We empower our people to realize their potential through life-changing work.

Responsibilities

• Contribute to and represent the clinical science function along with the study clinical lead in the development and execution of clinical trials across assets within the Neuroimmunology and Specialty Care portfolio.
• Support protocol concept development, write protocol documents, and develop or coordinate protocol amendments and updates.
• Develop and coordinate clinical trial related documents with cross-functional partners, including the Investigator’s Brochure, case report forms, informed consent forms, and the clinical development plan.
• Lead or contribute to data cleaning, integrated clinical statistical final study reports, and preparation of clinical study reports; support clinical sections of regulatory submissions such as Investigational New Drug applications and New Drug Applications.
• Support study start-up and execution activities including site interactions, monitoring plans, data quality, and resolution of unique or complex study issues.
• Collaborate with clinical operations, biostatistics, regulatory affairs, and medical affairs to align study design, deliverables, and regulatory strategy.
• Prepare budgets and clinical project forecasts, develop clinical timelines, and maintain project status reports to track progress across programs.
• Design and advise on recruitment strategies and feasibility assessments to meet enrollment targets for rare and complex disease populations.
• Prepare literature reviews and present clinical data at internal scientific meetings and at investigator meetings.
• Provide scientific support to other functions regarding the use of immunoglobulin products and lead training sessions on therapeutic-area topics and clinical study results for the Product Development Team.
• Mentor and coach junior staff, review work products, and help improve team processes and trial systems, including clinical trial management systems and electronic data capture platforms.

Qualifications

• Masters or other advanced degree (PharmD, DVM or PhD) in medicine, pharmacy, life sciences, or a related field, or equivalent experience.
• At least 5 years of experience in clinical development working on clinical trials.
• Demonstrated knowledge and application of Good Clinical Practice and the International Council for Harmonisation guidelines to clinical trial design and conduct.
• Experience in neuroimmunology, hematology, immunology, or other specialty areas relevant to plasma-derived therapies and rare diseases.
• Proven experience preparing clinical study protocols, Clinical Study Reports, integrated clinical statistical reports, and clinical sections for regulatory submissions across multiple regions, including Investigational New Drug and New Drug Application documentation.
• Clinical trial operations experience including study start-up, monitoring, data cleaning, quality oversight, and resolution of complex study issues.
• Experience with clinical trial systems, including clinical trial management systems and electronic data capture platforms, and familiarity with case report form design.
• Experience preparing clinical budgets, developing timelines, maintaining project status reports, and contributing to clinical supply forecasting.
• Ability to develop recruitment and site engagement strategies for complex or rare disease studies and to assess study feasibility.
• Demonstrated ability to lead or influence multidisciplinary, multi-regional teams and integrate input from diverse functional partners.
• Clear verbal and written communication skills tailored to scientific, clinical, and regulatory audiences; experience presenting data and training internal teams.
• Ability to use digital and artificial intelligence (AI) enabled tools, where permitted, to improve literature review, document drafting, and data review, applying good judgment and complying with applicable policies.
• Commitment to inclusive team practices and to working collaboratively across cultures and locations.

Skills

• Ability to solve various complex problems, sometimes referring to established precedents and policies.
• Experience in analyzing diverse data and selecting appropriate methods for solutions.
• Experience in networking with senior professionals in your field.
• Understanding of principles, concepts, and industry practices, exerting some influence on organizational objectives.
• Experience working independently under general direction, occasionally leading small project teams, and representing the organization in contractual or project matters.

Benefits

U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.

Pay

$116,000.00 - $182,270.00

Schedule

Hybrid