Clinical Scientist, Neuroimmunology & Specialty Care, PDT

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre 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.POSITION OBJECTIVES: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.POSITION ACCOUNTABILITIES: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.EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Expected: 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.This role requires experience in solving various complex problems, sometimes referring to established precedents and policies. The work involves analyzing diverse data and selecting appropriate methods for solutions, while networking with senior professionals in your field. Also, this role requires a person who possesses a complete understanding of principles, concepts, and industry practices, exerting some influence on organizational objectives. You often work independently under general direction, occasionally leading small project teams, and may represent the organization in contractual or project matters, interacting with senior internal and external personnel.This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.Empowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.#LI-JV2Takeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location:Boston, MAU.S. Base Salary Range:$116,000.00 - $182,270.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 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. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Reference: R0179022