Clinical Scientist, Neuroimmunology & Specialty Care, PDT

Takeda•Boston, MA

15h•Hybrid

About The Position

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Clinical Scientist, Neuroimmunology & Specialty Care, PDT in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. As part of the Plasma-Derived Therapies Business - Research and Development group, the Clinical Scientist will support the team in advancing new therapeutic approaches for people with rare and complex diseases. This role will work within the Neuroimmunology and Specialty Care team to support development of clinical assets across the United States, the European Union, and Japan, including protocol concept and protocol development, study start-up and execution, data cleaning, preparation of clinical study reports, and contributions to regulatory filings. The Clinical Scientist will integrate medical, scientific, regulatory, and commercial perspectives to help drive programs toward regulatory approval and support clinical use of immunoglobulin products.

Requirements

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.
Comfort using 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.
Experience in solving various complex problems, sometimes referring to established precedents and policies.
Ability to analyze diverse data and select appropriate methods for solutions, while networking with senior professionals in your field.
Complete understanding of principles, concepts, and industry practices, exerting some influence on organizational objectives.
Ability to work independently under general direction, occasionally leading small project teams.
May represent the organization in contractual or project matters, interacting with senior internal and external personnel.

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.
Support preparation of 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.