Director, Translational Biomarker Lead, Liver Diseases
Company: Takeda Pharmaceutical
Location: La Mesa
Posted on: May 9, 2022
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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 Director, Translational Biomarker Lead, Liver
Diseases in our Cambridge, MA or San Diego, CA 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 mission.POSITION OBJECTIVES: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 NASH, liver fibrosis and other liver diseases 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.POSITION ACCOUNTABILITIES:
- 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
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
communities.DIMENSIONS AND ASPECTS:Technical/Functional (Line)
- Outstanding expertise and depth of knowledge within liver
fibrosis, other liver diseases and translational biomarkers
- Keeps up with the up-to-date scientific advancement (e.g.
competitive landscape, new technology, new research portfolio, and
new partnership).Leadership -
- Has significant organizational leadership responsibility,
including primary responsibility 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.Interaction -
- Initiates and leads external interactions and
- Frequent contact with internal and external personnel at
various management levels.Innovation -
- Determines methods on new assignments; makes strategic
recommendations on projects.Complexity -
- Operate in matrix environment representing Translational
Biomarker function on discovery and development teams.TRAVEL
- Requires approximately 15 - 25% travel.
- Some international travel may be required.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: NASH, liver fibrosis, and/or other liver 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 ProgramsEmpowering Our People to
ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters
Please.This job posting excludes CO applicants.#LI-KL1EEO
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, MASan Diego, CAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, La Mesa , Director, Translational Biomarker Lead, Liver Diseases, Executive , La Mesa, California
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