Clinical Scientist, Clinical Science Rare Genetic and Hematology (RGH) Therapeutic Area
Company: Takeda Pharmaceutical
Location: East Brunswick
Posted on: May 12, 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 and . 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 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 ProgramsEmpowering Our People to
ShineDiscover more at takedajobs.comNo 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
Keywords: Takeda Pharmaceutical, East Brunswick , Clinical Scientist, Clinical Science Rare Genetic and Hematology (RGH) Therapeutic Area, Other , East Brunswick, New Jersey
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