Biomarker Sample Manager - Oncology
Company: Takeda Pharmaceutical
Location: Malden
Posted on: May 11, 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?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.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. -JOB DESCRIPTIONAre you
looking for a patient-focused, innovation-driven company that will
inspire you and empower you to shine? Join us as a -Biomarker
Sample Manager in our -Cambridge, MA -office.Takeda is committed to
outsmarting cancer so that more patients may have access to our
transformational medicines - a robust precision and translational
medicine approach thoughtfully and strategically applied in drug
development is of critical importance to achieve this important
objective of our Oncology drug development organization. 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.The
Clinical Biomarker Sample Manager is an exciting, high visibility,
high impact role in the Clinical Biomarker Operations Team within
Precision & Translational Medicine (PTM) function in the Oncology
Therapeutic Area Unit (OTAU) at Takeda. The desired candidate will
work with stakeholders within PTM and cross-functionally with
partners in Clinical Pharmacology, Clinical Biomarker Innovation
and Development, Clinical Operations, Procurement, R&D and IT
Quality, and Clinical Data Solutions to support clinical biomarker
sample management and logistics with external vendors thereby
helping generate high quality Translational biomarker data.
-POSITION ACCOUNTABILITIESClinical Biomarker Sample Manager is
responsible for the life cycle management of clinical bioanalytical
(PK, ADA) and biomarker samples, and maintain sample
chain-of-custody in a GxP-compliant setting. - Responsibilities
include:
- Support the planning and coordination of clinical sample
activities required to manage the lifecycle of biospecimen samples
(e.g., collection, shipping, processing, analysis, data delivery
and cleaning, and final sample disposition).
- Responsible for the development of Biomarker Sample Management
Plans.
- Implement sample tracking systems/databases for new studies. -
Provide centralized support to Takeda sample tracking
systems/databases.
- Support Biomarker Operations Leads with biomarker sample
tracking and management at study level, in close collaboration with
the Translational Team, Clinical Study Team, CRO and Central
Laboratory.
- Support Biomarker Operations Leads with resolution of biosample
related data reconciliation and sample related issues at sites or
analysis labs in collaboration with relevant stakeholders including
Data Management, Clinical Operations and Clinical Biomarker
team.
- Drive a harmonized process to support each study team to
deliver raw bioanalytical and biomarker data to meet study level
timelines and milestone deliverables (e.g. Interim Analysis,
Database Lock).
- Assist Biomarker Operations Leads to ensure that samples are
used and/or stored appropriately per the associated Informed
Consent.
- Support inventory reviews and work with the appropriate
stakeholders to obtain approvals for disposal/transfer of samples
in long-term storage facilities.
- Support biobanking related logistical and operational
activities.EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- BS, MS or PhD in Biochemistry, Biology, Medical Technology,
Immunology, Pharmacy, or related pharmaceutical sciences.
- BS (8+), MS (5+) and PhD (2+) years of relevant work experience
in drug development, sample/biospecimen management or clinical
trial project management.
- Knowledge of clinical trials and understanding of the role of
biomarkers in clinical studies a plus.
- Ability to oversee sample management activities across multiple
projects.
- Demonstrated ability to collaborate with a diverse group of
scientists, clinicians, vendor labs, and a variety of internal and
external team players to support product strategy.
- Excellent written, organizational, and interpersonal
communications skills to update the stakeholders and internal team
members efficiently and succinctly on progress, address questions
and issues as well as interface with external vendors.
- Strong attention to detail, timelines and accuracy.
- Works successfully under pressure with tight timelines.
- Works effectively in a dynamic operational environment with
cross functional stakeholders.
- Working knowledge of FDA & ICH/GCP regulations and clinical
laboratory specimen handling. Knowledge of regulations from other
regions (e.g. China and Brazil) a plus.
- Experience with Labmatrix or equivalent sample management
software is a plus.
- Proven critical reasoning skills including the identification
and resolution of complex problems.
- Eager to grow and develop capabilities.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 ProgramsAbsent 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.Empowering Our People to ShineDiscover more at
takedajobs.comNo Phone Calls or Recruiters Please.#LI-JT1EEO
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, Malden , Biomarker Sample Manager - Oncology, Executive , Malden, Massachusetts
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