Director, Translational Biomarker Lead, IBD ()
Company: Takeda Pharmaceutical
Location: North Chelmsford
Posted on: August 7, 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
Director, Translational Biomarker Lead, IBD in our San Diego, CA
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
leader whose primary role is to provide scientific and strategic
leadership in developing the translational biomarker strategy for
the IBD (including fistulizing, stricturing, and fibrostenosing)
pipeline programs in the preclinical and clinical stages. This is a
highly visible, strategic and matrixed role, responsible for
leading a team and 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. Responsible for independently developing
translational and biomarker plans as part of the overall Asset
Strategy in the Global Product Teams through all stages of clinical
development and post-market activities.
- 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 and to define
candidate biomarkers for mechanism of action and surrogates of drug
- 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.
- Manage a team of junior colleagues and collaborate across
multiple sites and functional areas, working closely with physician
scientists, clinical leads, 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 IBD
(including fistulizing, stricturing, and fibrostenosing)
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 IBD,
fistulizing, stricturing, fibrostenosing disease and translational
- Keeps up with the up-to-date scientific advancement (e.g.
competitive landscape, new technology, new research portfolio, and
- Has significant organizational leadership responsibility,
including primary responsibility for representing the Translational
Biomarker Function on project teams and senior management meetings
for a defined function, department, or research area.
- Hires, manages, mentors, motivates, empowers, develops and
retains staff to support assigned activities. Conducts performance
reviews and drive goal setting and development planning.
Decision-making and Autonomy
- Independently manages workload and expectations.
- Scientifically independent.
- Scientific driver for research strategy that impacts group
internally and outside area of function.
- Initiates and leads external interactions and
- Frequent contact with internal and external personnel at
various management levels.
- Determines methods on new assignments; makes strategic
recommendations on projects.
- Operate in matrix environment representing Translational
Biomarker function on discovery and development teams.
- Ability to drive to or fly to various meetings, including
overnight trips. Some international travel may be required.
- Requires approximately 15 - 25% travel.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- PhD and/or MD degree in relevant field with 10+ years of
- At least 5 years of experience in translational biomarker
research. Managerial experience desired.
- Experience in any combination of the following areas is
required: IBD-including fistulizing, stricturing, fibrostenosing
diseases, fibrosis biomarkers research (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.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution
- Tuition reimbursement Company match of charitable
- Health & Wellness programs including onsite flu shots and
- 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.
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, Boston , Director, Translational Biomarker Lead, IBD (), Executive , North Chelmsford, Massachusetts
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