Scientific Director, Research
Company: Takeda Pharmaceutical
Location: Boston
Posted on: October 22, 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 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 Scientific
Director, Research, in our Cambridge, Massachusetts office.
- The Bioanalytical and Biomarker Science and Technologies (BST)
department at Takeda is seeking a strong scientific and strategic
leader to join the group as the BST Single Point of Contact (SPoC)
for the Oncology Therapeutic Area to support clinical development
of novel therapeutics across a range of modalities (e.g. small
molecules, antibodies, bi-specifics, nucleic acids, cell therapies,
and more).
- This is a strategic role that reports to the Head of BST and
serves as a single point of contact to the Oncology Precision and
Translational Medicine (PTM), Quantitative Clinical Pharmacology
(QCP), Drug Discovery Unit (DDU), Therapeutic Area Unit (TAU), and
other applicable cross-functional partners.
- The candidate will work closely with the PTM, QCP, TAU and DDU
leadership to define portfolio needs in terms of bioanalytical and
biomarker support, translate the needs into the BST strategy and
plans, monitor execution and ensure timely fit-for-purpose assay
and data delivery to support portfolio progression.How you will
contribute:ACCOUNTABILITIES -
- The BST oncology SPoC will be the face of BST to functions
within PTS (e.g., DMPK, DSRE, Imaging, etc.) and external partners
ensuring a consistent BST strategy is messaged between BST Leads
and stakeholders. Attends applicable meetings for cross-functional
alignment.
- Responsible for strategy and deliverables in collaboration with
BST Leads, Functional Heads and Key Stakeholders (DDU, TAU, PTS,
PTM, QCP, etc.) providing guidance to BST Leads on scientific
strategy and execution relating to all BST deliverables (study
start up, context-of use-based assays and associated regulatory
guidance, clinical development plans, study protocols, testing
strategies, data review and QC, database locks, clinical study
reports, regulatory filings and communications, etc.). They may
assist in issue resolution and escalate issues as needed.
- Maintains portfolio level book of work, ensuring adequate
resourcing and skill alignment, and assist in budget review.
- Reviews relevant content in key reports, governance documents
that contain BST content, and regulatory documentation and
communications (e.g., protocols, CSR, IND, NDA, BLA, PMA, briefing
books, investigator brochures, Health Authority filings and
queries, etc.). They may assist in the writing of Regulatory
Responses to Health Authority Inquiries, Questions, and Requests
for Information and escalate to the BST LT (Leadership Team) and/or
stakeholders as needed.
- Participates in Due Diligence and other alliance opportunities
for corresponding TAU/DDU, delegating to SME (Subject Matter
Expert) as needed.
- Cultivates cross-program efficiencies, learnings, and aligned
practices. Influences and inspires team members, and maintains a
culture of innovation, scientific rigor, operational excellence,
and collaboration.
- Success in this role will be evaluated by the ability to build
effective partnership with relevant colleagues within PTS, PTM,
QCP, DDU, TAU and other collaborators, align and deliver on BST
deliverables with a focus on high-quality, fiscally responsible and
timely delivery of PK, immunogenicity and biomarker data for
clinical trials.
- Develops and mentors junior DMPK team membersDIMENSIONS AND
ASPECTS Leadership
- The BST oncology SPoC will serve as a key member of the BST
leadership team helping drive strategic and tactical operations and
formulating broad, long-ranging goals in support of BST and PTS
goals.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 cross-departmental interactions and
collaborations
- Frequent contact with internal and external personnel at
various management levelsInnovation
- Makes strategic recommendations for BST oncology portfolio in
alignment with stakeholders.Minimum Requirements/Qualifications:
- PhD degree in a scientific discipline with 10+ years'
experience, or MS with 14+ years' experience, or BS with 16+ years'
relevant experience in immunology, oncology and/or immuno-oncology,
new modalities, a deep understanding of bioanalytical and biomarker
strategies, applicable regulatory guidance, clinical trials,
endpoints and deliverables.
- 10+ years in the biotechnology or pharmaceutical industry and
should be able to work with the BST leads and SME to identify and
resolve issues related to drug development and clinical asset
progression and decision making.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:$169,400.00 - $266,200.00The 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, Revere , Scientific Director, Research, Executive , Boston, Massachusetts
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