Associate Scientific Director, Pathology
Company: Takeda Pharmaceutical
Location: Boston
Posted on: September 30, 2024
Job Description:
By clicking the "Apply" button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda's and . I further attest 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 a Scientific Director, Pathology in Cambridge, MA, where
you will be responsible for active cross-functional collaboration,
interdisciplinary project team participation, scientific leadership
in the design and implementation of safety assessment strategies to
support program advancement and decision-making, primary evaluation
and peer review of pathology specimens and data, preparation and
review of regulatory documentation, study reports and manuscripts.
You will also be a representation of Takeda at conferences and
meetings with regulatory authorities, manage investigations into
mechanisms of toxicity, proactive management of potential safety
liabilities and communication of impact to teams and governance
committees, and participation in cross-industry consortia and
professional society initiatives.As part of the DSRE, Pathology
team, you will report to the Senior Director DSRE - Pathology and
serve as a project pathologist and/or project toxicology
representative to project teams within the Global Pathology group
in Drug Safety Research and Evaluation (DSRE) through the provision
of anatomic/clinical pathology and toxicology expertise.How you
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- Serve as an integral PTS and DSRE member on project teams to
collaborate with project and cross functional leaders with R&D
to ensure transition of programs into development.
- Serve as a departmental subject matter expert in due diligence
teams supporting external collaborations or licensing
opportunities.
- Perform integrative macroscopic and microscopic primary reads
and peer reviews of animal tissues from toxicology, investigative,
translational and discovery studies; interpret observations and
determine the biologic and toxicologic significance of clinical
pathology, organ weight, necropsy, and histopathology data in the
context of other study data.
- Effectively communicate pathology data and other safety data
along with their implications to a broad audience in study reports,
regulatory documents, and project team meetings and make
recommendations for how these data impact the project team strategy
and decision making.
- Author and review regulatory documents (BB, IND, IB, DSUR, BLA,
MAA, NDA, JNDA) for technical accuracy, regulatory adequacy and
respond to health authorities concerning toxicology issues.
- Lead strategies for investigating and de-risking potential
toxicology issues.
- Provide scientific direction and pathology expertise to project
specific IHC, ISH and spatial endpoints in collaboration with the
DSRE Investigative Pathology and Toxicology labs, DMPK, and Drug
Discovery Unit translational pathology groups.
- Provide mentorship and/or direct oversight of junior
pathologists.
- Participate in local and national toxicology/pathology meetings
and represent Takeda in professional society committees, working
groups and cross industry consortia.Minimum
Requirements/Qualifications:
- DVM (or equivalent) and Ph.D.
- Board certified by the American College of Veterinary
Pathologists (ACVP), European College of Veterinary Pathology
(ECVP) or Japanese College of Veterinary Pathology (JCVP).
- Proficiency in veterinary anatomic and/or clinical
pathology.
- 20+ years pharmaceutical drug development experience including
as a project team representative and due diligence activity.
- Experience with alternative modalities specifically including
RNAi GalNAc, lipid nanoparticles, oligonucleotides, antibodies and
conjugates, small molecules and alternative routes of
administration is desired.
- Strong decision-making, complex problem solving, critical data
analysis and interpretation.
- Excellent communication skills (written and oral).
- Ability and desire to take on leadership roles.
- Proficiency with computer systems such as word processing,
spreadsheets, databases, knowledge of Halo, Visiopharm, Patholytix
or Pristima (or other pathology data capture systems) also
desirable.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 world.This position is currently
classified as "hybrid" by Takeda's Hybrid and Remote Work policy.
This position requires the candidate to come onsite to Cambridge
location minimum 5x/month.Takeda Compensation and Benefits
SummaryWe 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:Boston, MAU.S.
Base Salary Range:$149,100.00 - $234,300.00The 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-term incentives. 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 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, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Boston , Associate Scientific Director, Pathology, Executive , Boston, Massachusetts
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