Associate Director, Quantitative Clinical Pharmacology (QCP) Lead
Company: Takeda
Location: Boston
Posted on: April 2, 2026
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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 Are you looking for a
patient-focused, innovation-driven company that will inspire you
and empower you to shine? Join us as Associate Director,
Quantitative Clinical Pharmacology Lead in our Cambridge, MA
office. At Takeda, we are transforming the pharmaceutical industry
through our R&D-driven market leadership and being a values-led
company. To do this, we empower our people to realize their
potential through life-changing work. Certified as a Global Top
Employer, we offer stimulating careers, encourage innovation, and
strive for excellence in everything we do. We foster an inclusive,
collaborative workplace, in which our global teams are united by an
unwavering commitment to deliver Better Health and a Brighter
Future to people around the world. Here, you will be a vital
contributor to our inspiring, bold mission. POSITION OBJECTIVES:
Takeda is a global, values-based, R&D-driven, top 10
biopharmaceutical leader committed to discover and deliver
life-transforming treatments, guided by our commitment to patients,
our people and the planet. Our Data and Quantitative Sciences group
(DQS) is made up of more than 500 quantitative scientists who
harness the insight of data and digital to speed the development of
highly innovative treatments to patients. These scientists (from
quantitative clinical pharmacology, statistics, programming,
outcomes research and epidemiology, patient safety &
pharmacovigilance, digital strategy, library sciences and data
architecture/governance) bring their expertise to our global
program teams and reimagine our disciplines. They work with novel
data streams, including real-world data and digital tools, and
apply advanced analytics including artificial intelligence and
automation. As part of DQS, the Quantitative Clinical Pharmacology
(QCP) Team at Takeda consists of therapeutically aligned teams who
drive the clinical pharmacology strategy from pre-FIH through
life-cycle management within the global project team. The QCP role
works in partnership with the pharmacometrics lead to drive a MIDD
path within each project. Leads strategic, scientific, and
operational aspects of multiple drug development projects with a
high level of technical and strategic independence from first in
human dosing through life cycle management. Possesses primary
responsibility for dosage selection and generation of causality
evidence. Provides additional portfolio support through program
reviews, collaborative decision-making, infrastructure and best
practice initiatives. Explores and excels in synergistic
relationships with experts in digital health, global
outcomes/epidemiology, biostatistics, and other key data science
disciplines. Serves as an ambassador of Quantitative Clinical
Pharmacology (QCP) and Data Sciences Institute (DSI) to the R&D
organization and the external scientific community through
high-value participation at scientific meetings and impactful
publications. POSITION ACCOUNTABILITIES: Provides scientific and
strategic leadership as the Global or Regional Clinical
Pharmacology Lead for multiple projects on Global Program Teams and
associated scientific and operational sub-teams. Be charged with
integrating pharmacokinetic, pharmacodynamic, efficacy and safety
data from multiple sources to optimize dosing for different
populations across the development continuum. Be responsible for
drafting and executing clinical pharmacology plans, including
integration of M&S, in close collaboration with key partner
functions (e.g., pharmacometrics, statistics, and DMPK). Enables
impactful Model-Informed Drug Development (MIDD) practices and
advanced modeling and simulation approaches (e.g., QSP, MBMA) to
inform internal decisions and external regulatory interactions.
Represents Clinical Pharmacology in meetings with global or
regional regulatory agencies and be responsible for clinical
pharmacology summary documents for regulatory submissions. Oversees
and/or independently performs PK, PD, and pharmacometric analyses
including the interpretation of PK/PD data in close partnership
with DSI and external partners. Maintains a high standard for good
clinical practice, compliance, and ethics. Mentors junior staff to
promote scientific excellence and individual achievement.
Participates as a member of Business Development due diligence,
when requested. Contributes to infrastructure initiatives and/ or
cross-functional best practice initiatives. Has scientific
influence outside QCP and Takeda through presentations and
publications and active contribution to scientific societies and
cross-industry consortiums related to the clinical pharmacology
discipline such as ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Education: Pharm D.
or PhD with 5 years of working experience in a quantitative field
with some exposure to clinical pharmacology /PK-PD MS with 8 years'
working experience in a quantitative field with some exposure to
clinical pharmacology/PK-PD Technical Skills: Advanced knowledge
and experience in clinical pharmacology responsibilities in early &
late stage and post-marketing studies. Formulates and executes
clinical pharmacology plans including integration of MIDD
principles. Advanced knowledge of pharmaceutical industry, overall
drug development process with expertise in the cross-functional
interfaces with key partners such as Pharmacometrics, Statistics,
Drug Safety, Clinical Sciences, Outcomes, Digital Health,
Pharmaceutical Sciences/Device, and Global Regulatory Affairs.
Advanced knowledge of regulatory guidance for industry applicable
to the design, analysis of clinical trials and process for
regulatory submissions across different regions (ICH, FDA, EMA and
others). Advanced knowledge and/or hands-on applications in
integration of PK, PD, efficacy, and safety data from multiple
sources for dose selection and decision-making. Subject matter
expertise in several clinical pharmacology areas and establishes
oneself as a go-to colleague on a few topics. Scientific
understanding of biological translation, drug development and its
integration into the clinical pharmacology/pharmacometrics
strategy. This position is currently classified as “ hybrid” in
accordance with Takeda’s Hybrid and Remote Work policy. Empowering
Our People to Shine Discover more at takedajobs.com No Phone Calls
or Recruiters Please. LI-JV2 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: Boston, MA U.S.
Base Salary Range: $153,600.00 - $241,340.00 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-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 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 Boston, MA 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: Takeda, Boston , Associate Director, Quantitative Clinical Pharmacology (QCP) Lead, Science, Research & Development , Boston, Massachusetts