Biomarker Sample Manager - Oncology
Company: Takeda Pharmaceutical
Location: Mc Sherrystown
Posted on: May 13, 2022
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Job Description:
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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?
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 DESCRIPTION
Are 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 ACCOUNTABILITIES
Clinical 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 Programs
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.
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
#LI-JT1
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, Ellicott City , Biomarker Sample Manager - Oncology, Healthcare , Mc Sherrystown, Maryland
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