Clinical Scientist, Clinical Science Rare Genetic and Hematology (RGH) Therapeutic Area

Company: Takeda Pharmaceutical
Location: Swampscott
Posted on: August 7, 2022

Job Description:

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 Description 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, 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 searches
• Assist in the data review of patient profiles and develop site queries as needed
• Summarize 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 study
• Support CDL to provide scientific leadership in execution of clinical trials
• Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, data management, pharmacovigilance to ensure quality processes and deliverables
• Assist with ongoing monitoring of safety data and participates in drug safety surveillance for Development projects
• Collaborates with CDL, and Global Product Team Lead, to ensure that all development and product support activities for the assigned projects are coordinated and consistent.
• Interacts 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 required
  • Minimum 2+ years) in clinical research within the pharmaceutical industry CRO or similar organization.
  • Demonstrated ability to collaborate in a matrixed environment
  • Experience in submissions of IND/CTA/NDA/MAA and interactions with Regulatory authorities
  • Experience in designing and conducting clinical trials; and/or significant late-stage development research.
  • Experience in rare diseases a plus
  • Able to work independently, prioritize and meet project timelines
  • Able 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 backgrounds
  • Good 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 applied.
    • In 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 Plan
      • Tuition reimbursement Company match of charitable contributions
      • Health & Wellness programs including onsite flu shots and health screenings
      • Generous time off for vacation and the option to purchase additional vacation days
      • Community Outreach Programs Empowering Our People to Shine Discover more at No Phone Calls or Recruiters Please.EEO Statement Takeda 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. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical, Boston , Clinical Scientist, Clinical Science Rare Genetic and Hematology (RGH) Therapeutic Area, Healthcare , Swampscott, Massachusetts