Director, Translational Biomarker Lead, Inflammation/IBD
Location: Cambridge
Posted on: June 23, 2025
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Job Description:
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that all information I submit in my employment application is true
to the best of my knowledge. Job Description OBJECTIVES/PURPOSE
This position requires an acknowledged scientific and strategic
leadership with managerial experience. The primary role is to
provide scientific and strategic leadership in developing the
translational biomarker strategy, and plans to secure
implementation for Inflammatory diseases and IBD (Fibrostenotic
CD), in the preclinical and clinical stages. This is a highly
visible, strategic, and matrixed role, responsible for leading the
Translational sub team (TST) partnering with Gastro-Intestinal &
Inflammation drug discovery unit (GI2-DDU) research scientists,
Gastro-Intestinal & Inflammation Therapeutic Area Unit (GI2-TAU)
physician-scientists, clinical sciences, and relevant partner lines
and functions to identify and validate biomarkers relevant to
patients in clinical studies. Responsible for independently
developing translational biomarker plans, aligned with functional
leadership, as part of the overall Asset Strategy in the Discovery,
Global Product Teams, and Medical sub-teams through all stages of
discovery, clinical development, and post-market activities. Secure
implementation and delivery of data and interpretation.
ACCOUNTABILITIES Partner with GI² DDU research scientists and GI²
TAU physician-scientists in designing and executing Translational
Research to discover and validate targeted pathways based on human
data and define candidate biomarkers for mechanisms of action and
drug response. Lead Translational Biomarker strategy development
and execution to support the pre-clinical and clinical stage
portfolio, including biomarker-driven clinical study design,
implementation of novel technologies, and incorporation of
biomarker endpoints for decision-making in early-stage clinical
trials. Lead Translational subteam (TST) and provide matrix
leadership and enhance collaboration across multiple functional
areas, working closely with physician-scientists, clinical leads,
clinical pharmacologists, BST, discovery research scientists,
regulatory, non-clinical and other functions 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 strategies and
support translational medicine goals of the assigned programs in
all phases of clinical development. Contribute as a key member of
the project teams that provide strategic, technical, and scientific
leadership for the progression of the 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 with BST and ensure high scientific quality of target
engagement/pharmacodynamics, prognostic and predictive biomarker
data to drive program decision-making. Evaluate and utilize
state-of-the-art scientific tools and ensure implementation of
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 translational biomarker research. Responsible for the
preparation and review of biomarker sections of candidate
nomination, PRC documents, CDP, clinical protocols, ICFs 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, consortia, consultants, university representatives,
NIH, and Regulatory Agencies, as required. Establish and maintain a
scientific dialog with KOLs and clinical translational experts in
medical, academic, and regulatory communities. Technical/Functional
(Line) Expertise Outstanding expertise and depth of knowledge
within fibrotic diseases in Inflammatory Disease (Dermatology) and
IBD (Fibrostenotic CD) and translational biomarkers applications
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 leading
the TST and representing Translational Biomarker aspects on project
teams. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS PhD and/or MD
degree in relevant field with 10 years of experience At least 7
years of experience in translational biomarker research. Managerial
experience desired. Experience in any combination of the following
areas is required: Inflammatory disease (Dermatology, Respiratory,
Atopic diseases), IBD (Fibrostenotic CD) biomarkers research
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 This position is currently
classified as “hybrid” by Takeda’s Hybrid and Remote Work policy
Takeda Compensation and Benefits Summary We understand compensation
is an important factor as you consider the next step in your
career. We are committed to equitable pay for all employees, and we
strive to be more transparent with our pay practices. For Location:
USA - MA - Cambridge - Binney St U.S. Base Salary Range:
$174,500.00 - $274,230.00 The estimated salary range reflects an
anticipated range for this position. The actual base salary offered
may depend on a variety of factors, including the qualifications of
the individual applicant for the position, years of relevant
experience, specific and unique skills, level of education
attained, certifications or other professional licenses held, and
the location in which the applicant lives and/or from which they
will be performing the job.The actual base salary offered will be
in accordance with state or local minimum wage requirements for the
job location. U.S. based employees may be eligible for short-term
and/or long-termincentives. U.S.based employees may be eligible to
participate in medical, dental, vision insurance, a 401(k) plan and
company match, short-term and long-term disability coverage, basic
life insurance, a tuition reimbursement program, paid volunteer
time off, company holidays, and well-being benefits, among others.
U.S.based employees are also eligible to receive, per calendar
year, up to 80 hours of sick time, and new hires are eligible to
accrue up to 120 hours of paid vacation. 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 USA - MA - Cambridge - Binney St Worker Type Employee
Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is
unlawful in Massachusetts to require or administer a lie detector
test as a condition of employment or continued employment. An
employer who violates this law shall be subject to criminal
penalties and civil liability.
Keywords: , Marthas Vineyard , Director, Translational Biomarker Lead, Inflammation/IBD, Science, Research & Development , Cambridge, Massachusetts
