Head of Clinical Pathology, Director, Research
Posted on: November 20, 2023
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About 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 three
therapeutic areas and other targeted investments, we push the
boundaries of what is possible in order to bring life-changing
therapies to patients worldwide.
Are you looking for a patient-focused, innovation-driven company
that will inspire you and empower you to shine? Join us as a Head
of Clinical Pathology, Director, Research in our Cambridge,
- The Bioanalytical and Biomarker Sciences and Technologies (BST)
department at Takeda is seeking a strong scientific and strategic
leader to join the group as a clinical pathology expert and the
Head of the team supporting pathology/IHC biomarkers in clinical
development programs across therapeutic areas and modalities.
- The candidate will work closely with the the BST leadership
team, program-specific translational teams and key stakeholders
across Takeda to support implementation of pathology/IHC biomarkers
and delivery of key assays and data to clinical trials to
facilitate decision making.
- Lead the Clinical Pathology group and provide direction to the
team by serving as a Physician Scientist in Pathology who has
strong knowledge in current clinical practice in the
Gastrointestinal, Hepatobiliary, Dermatology, or other related
How you will contribute:
- Create, communicate and execute upon a clear vision and
strategy for the Clinical Pathology group within BST to support
delivery of key pathology/IHC assays and data to clinical trials to
facilitate decision making across the portfolio
- Oversee the histopathology work for tissue based clinical assay
development including, but not limited to single and multiplex
immunohistochemistry or immunofluorescence, spatial
transcriptomics, digital pathology, and pathology-based image
- Provides leadership and strategic support to other parts of the
Takeda organization, and/or to external collaborators
- Develop organizational culture and capabilities
- Manage resourcing and budget planning for his/her area of
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Outstanding expertise and depth of knowledge within pathology;
molecular and histopathology techniques
- Knowledge of clinical pathology workflows and implementation
into clinical trials.
- Strong scientific background and experience with assay
development and validation across technology platforms in
pathology, especially those that are clinically amenable (e.g. IHC,
ISH, IF, and multiplex assays).
- Up-to-date knowledge of scientific advancement in pathology
including digital pathology and spatial biology
- Lead scientific due diligence to assess cutting-edge
technologies and establish external partnerships as needed, as well
as, actively publishing in the scientific community external to
- Broad recognition for in-depth expertise in a scientific
- Scientific leadership role, setting high standards for
effectiveness of execution, and rigor of thought
- Has significant managerial responsibility and oversees team of
scientists within BST
- Must be able to lead in a matrixed environment and ensure high
quality results from individuals not in direct line of
- Success in this role will be evaluated by the ability to
influence and inspire scientists in the organization, and maintain
a culture that encourages innovation, scientific rigor, and growth
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
- Serve as the BST program lead and coordinate all BST activities
for programs and act as the liaison with the larger
- Frequent contact with internal and external personnel at
various management levels
- Build relationships and collaborate with scientific leaders,
KOLs, academic partners, CROs, and health authorities.
- Collaborate with clinical operations and CRO labs to ensure
high quality data delivery.
- Collaborate with translational medicine scientists,
computational scientists, and statisticians to perform data mining
and interpretation and present the data in project team
- Initiates and leads external interactions and collaborations as
- Determines methods on new assignments; makes strategic
recommendations on projects
- Subject matter expert in the development and validation of
clinical grade assays, as well as, assays using various advanced
technologies that may not be currently in clinical use.
- Perform evaluation and selection of adequate technologies for
establishment of clinical biomarker assays that meet clinical
laboratory standards and regulatory requirements.
- Proposes new processes for the group
- Initiate technology/vendor selection, plan fit-for-purpose
assay validation, oversee/review the validation process and report
from CRO to ensure that the report meets regulatory
- MD or MD/PhD degree in a scientific discipline with at least 10
years of relevant experience beyond post-doctoral training,
including at least 5 years of industry experience.
- Strong experience in inflammatory bowel disease, inflammation,
liver fibrosis and/or psoriasis and strong knowledge in current
disease diagnostic criteria and standard of care in
Hepato-Gastroenterology is a plus
- Several years of experience utilizing technical platforms (e.g.
IHC, PCR, or NGS) for clinical biomarker investigation in drug
- A track record of sustained, significant scientific
contributions as demonstrated by publications, patents, and
presentations is required.
- Extensive drug development experience preferably advancing
several molecules from phase I to approval and supporting
- Experience with outsourcing and working with external partners
to develop/transfer assays and to oversee data generation/analysis
and delivery of high quality data within expected timelines.
- Strong scientific background and experience with assay
development and validation as well as complex image and data
- Familiarity with clinical documents and processes, i.e.
clinical protocols, informed consent forms, laboratory manuals,
central lab logistics, etc.
- Capable of applying the highest scientific and technical
standards for the successful design and execution of clinical
assays implemented from early to late-stage clinical programs.
- Strong communication skills, ability to influence and inspire,
preferably experienced in navigating and influencing large, highly
complex, global matrixed environments.
- Experience in mentoring scientists in the above, and a proven
ability to build an effective organization by attracting, retaining
and developing high-caliber scientists.
- Broad and strong network in the industry, biotech, and health
- Experience with regulatory agency interactions a plus
- Subject matter expert in one of the therapeutic areas,
knowledgeable about Takeda's other therapeutic areas: Neuroscience,
Gastroenterology, and/or Rare Diseases is a plus.
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
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursement
More 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
This position is currently classified as "hybrid" in accordance
with Takeda's Hybrid and Remote Work policy.
- The role is based in Cambridge, MA
- Travel requirements may be 5-10%, primarily within the USA
Base Salary Range: $ 217,000-$310,000 . Employees may also be
eligible for Short Term and Long-Term Incentive benefits. 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.
The final salary offered for this position may take into account a
number of factors including, but not limited to, location, skills,
education, and experience.
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.
USA - MA - Cambridge - Binney St
Keywords: Takeda, Cambridge , Head of Clinical Pathology, Director, Research, Executive , Cambridge, Massachusetts
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