Associate Director Translational Biomarker Lead Celiac Disease
Company: Takeda Pharmaceutical
Posted on: May 12, 2022
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Are you looking for a patient-focused, innovation-driven company
that will inspire you and empower you to shine? Join us as a
Associate Director, Translational Biomarker Lead, Celiac Disease in
our Cambridge, MA offices.
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
This position requires an acknowledged technical and strategic
expert whose primary role is to provide scientific leadership,
research planning and decision making in assigned projects in
Celiac disease in the preclinical and clinical stages. This is a
highly visible and matrixed role, responsible for partnering with
Gastro-Intestinal drug discovery unit (GI-DDU) research and
physician scientists and project teams to identify and validate
biomarkers relevant to patients in clinical studies. Work closely
with functional line leadership to develop translational and
biomarker plans as part of the overall Asset Strategy in the Global
Product Teams through all stages of clinical development and
Partner with GI-DDU discovery research and physician scientists in
designing and executing Translational Research to discover and
validate targeted pathways based on human data in the discovery
stages and to define candidate biomarkers for mechanism of action
and surrogates of drug efficacy.
Lead Translational Biomarker strategy development and execution to
support the clinical stage portfolio, including the biomarker
driven clinical study design, implementation of novel technologies
and incorporation of biomarker endpoints for decision making in
early-stage clinical trials.
Collaborate across multiple sites and functional areas, working
closely with physician scientists, medical directors, clinical
pharmacologists and nonclinical and discovery research scientists
to build consensus for a fit-for-purpose biomarker strategy.
Represent Translational and Biomarker Research on Project and
Global Product Teams to provide pharmacodynamic, disease and
predictive biomarker strategy and support translational medicine
goals of the assigned programs in all phases of clinical
Contribute as a key member of the project - teams that provides
strategic, technical and scientific leadership for progression of
program from discovery research through development and contribute
as a subject-matter expert for clinical development and overall
Implement fit-for-purpose validation for all clinical biomarker
assays and ensure high scientific - quality of pharmacodynamic,
prognostic and predictive biomarker data. Evaluate and utilize
state-of-the-art scientific tools and ensure implementation
cutting-edge technology to drive innovation in the execution of
Maintain extensive knowledge of the research and development
efforts from academic institutions, competitor biopharmaceutical
companies and fee-for-service bioanalytical CROs for relevant
Hepatology and Fibrosis translational biomarker research.
Responsible for the preparation and review of biomarker sections of
candidate nomination documents, clinical protocols and documents
submitted to Regulatory Agencies.
Support Business Development efforts by evaluating potential
in-licensing opportunities and serve as a liaison with external
companies, organizations, consultants, university representatives,
NIH, and with Regulatory Agencies, as required.
Establish and maintain scientific dialog with KOLs and clinical
translational experts in medical, academic and regulatory
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
Outstanding expertise and depth of knowledge within Celiac disease
and/or inflammation - and translational biomarker applications
Keeps up with the up-to-date scientific advancement (e.g.
competitive landscape, new technology, new research portfolio, and
Scientific leadership role, setting high standards for
effectiveness of execution, and rigor of thought
Decision-making and Autonomy
Independently manages workload and expectations
Scientific driver for research strategy that impacts group
internally and outside area of function
Initiates and leads external interactions and collaborations
Frequent contact with internal and external personnel at various
Determines methods on new assignments; makes strategic
recommendations on projects
Operate in matrix environment representing Biomarker function on
discovery and development teams
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
PhD and/or MD degree in relevant field with 8+ years of
At least 5 years of experience in translational biomarker
Experience in any combination of the following areas is required: :
Celiac and/or other related diseases (multiple openings at
different levels commensurate with experience).
Recognized expertise in biomarker discovery and development and
translational medicine as demonstrated by publications, regulatory
submissions and/or national or international presentations
Excellent understanding of drug development, regulatory processes
and clinical development
Strong leadership abilities and proven ability to lead a team
within a matrix organization as well as work independently
Strong analytical, oral and written communication, problem solving
and interpersonal skills
Requires approximately 15 - 25% travel. Some international travel
may be required.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health
Generous time off for vacation and the option to purchase
additional vacation days
Community Outreach Programs
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
This job posting excludes CO applicants.
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.
San Diego, CA
Keywords: Takeda Pharmaceutical, Somerville , Associate Director Translational Biomarker Lead Celiac Disease, Executive , Somerville, Massachusetts
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