Associate Director, Translational Biomarker Lead, IBD - Entyvio
Company: Takeda Pharmaceuticals
Location: San Diego
Posted on: January 27, 2023
Job Description:
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that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionAbout the role:At
Takeda, we are a forward-looking, world-class R&D organization
that unlocks innovation and delivers transformative therapies to
patients. By focusing R&D efforts on four therapeutic areas and
other targeted investments, we push the boundaries of what is
possible in order to bring life-changing therapies to patients
worldwide.Join Takeda as an Associate Director where you will
provide scientific and strategic leadership in developing the
biomarker strategy for the IBD focused on Entyvio also including
pipeline programs in the preclinical, clinical stages and
post-registration assets. You will also lead 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. As part of the
GI DDU, you will report to the VP & Head of Translational Medicine
& Biomarker Research.How you will contribute:
- Accountable for Translational Biomarker strategy and
implementation in partnership with the Global Medical Affairs
colleagues and cross-functional team working on Global IEP as a
part of the Global IBP for Entyvio.
- 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
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.
- Manage a team of junior colleagues and collaborate across
multiple sites and functional areas, working 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
development.
- Contribute as an important 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 asset strategies.
- 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
biomarker strategy.
- 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.
- Establish and maintain scientific dialog with KOLs and clinical
translational experts in medical, academic and regulatory
communities.Minimum Requirements/Qualifications :
- PhD or MD degree in relevant field with 10+ years of
experience
- 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
CD, UC fibrosis, fibrosis biomarkers research.
- Recognized expertise in biomarker discovery and development and
Translational Medicine documented by publications, regulatory
submissions and/or national or international presentations.
- Excellent understanding of drug development, regulatory
processes and clinical development.What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and
Annual Retirement Contribution Plan
- 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 and company match of charitable
contributions
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursementMore about us:At Takeda, we are
transforming patient care through the development of novel
specialty pharmaceuticals and best in class patient support
programs. Takeda is a patient-focused company that will inspire and
empower you to grow through life-changing work.Certified as a
Global Top Employer, Takeda offers stimulating careers, encourages
innovation, and strives for excellence in everything we do. We
foster an inclusive, collaborative workplace, in which our teams
are united by an unwavering commitment to deliver Better Health and
a Brighter Future to people around the world.This position is
currently classified as "hybrid" in accordance with Takeda's Hybrid
and Remote Work policy.Base Salary Range: $143,500.00 to
$205,000.00, based on candidate professional experience level.
Employees may also be eligible for Short Term and Long-Term
Incentive benefits as well. Employees are eligible to participate
in Medical, Dental, Vision, Life Insurance, 401(k), Charitable
Contribution Match, Holidays, Personal Days & Vacation, Tuition
Reimbursement Program and Paid Volunteer Time
Off.#LI-SGM#LI-HybridEEO 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 Pharmaceuticals, San Diego , Associate Director, Translational Biomarker Lead, IBD - Entyvio, Executive , San Diego, California
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