Clinical Scientist, Clinical Science Rare Genetic and ...

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, Clinical Science RGH, 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:Responsible for providing scientific support for the company''s clinical research and product development initiatives under the direction of GCDL POSITION ACCOUNTABILITIES:Provides clinical scientist input into regulatory questions, runs ad hoc searchesAssist in the data review of patient profiles and develop site queries as neededSummarize information relevant for various clinical documents preparation.Assist the Medical Monitor (CDL) in the review of trial data and development and review of clinical study documents, reports etc,Serve as a resource to address medical questions or clarify issues arising during conduct of the studySupport CDL to provide scientific leadership in execution of clinical trialsProvide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, data management, pharmacovigilance to ensure quality processes and deliverablesAssist with ongoing monitoring of safety data and participates in drug safety surveillance for Development projectsCollaborates with CDL, and Global Product Team Lead, to ensure that all development and product support activities for the assigned projects are coordinated and teracts as needed with Clinical Development partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams.Supports the CDL when participating in clinical/medical advisory panels, steering committees and investigator meetings.Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.Assists in the development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy.EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: MD/PharmD/PhD requiredMinimum 2+ years) in clinical research within the pharmaceutical industry CRO or similar organization.Demonstrated ability to collaborate in a matrixed environmentExperience in submissions of IND/CTA/NDA/MAA and interactions with Regulatory authoritiesExperience in designing and conducting clinical trials; and/or significant late-stage development research.Experience in rare diseases a plusAble to work independently, prioritize and meet project timelinesAble to effectively present information Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes; ability to build and support teams of diverse backgroundsGood analytical skills and ability to review emerging data and clinical outputs are required in order to make appropriate decisions and institute measures to ensure quality results and safety.It is expected that incumbent will take initiative and work independently, however, ongoing communication with CDL is a vital part of problem-solving and decision-making. Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution PlanTuition reimbursement Company match of charitable contributionsHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach ProgramsEmpowering Our People to ShineDiscover more at No Phone Calls or Recruiters Please.LI-JV2EEO 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 time

Created: 2025-10-04