Associate Director, Quantitative Clinical Pharmacology (QCP) Lead
Company: Takeda Pharmaceutical
Location: Boston
Posted on: October 29, 2024
Job Description:
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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 an Associate Director, Quantitative Clinical Pharmacology
Lead in Cambridge, MA, where you will lead 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. You will serve 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.Our Data Sciences
Institute (DSI) 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 DSI, 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.How you will contribute: -
- 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.
- Possess 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.
- 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.Minimum Requirements/Qualifications:
- 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.
- 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 difference 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.
- Independently works by delivering, and prioritizing QCP
activities across projects with minimal supervision. -
- Effectively drives and influences project teams towards
objectives while enabling and making decisions.
- Focuses on priorities and delivers on commitments.
- Strong communication skills and ability to translate
effectively across functional lines.
- Possess collaborative mindset, inspire teamwork, and is
effective at building alliance across functions.
- Assess benefit/risk of options.
- Develop understanding of business beyond
QCP/Pharmacometrics.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 "remote" by Takeda's Hybrid and Remote Work policy.
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, Providence , Associate Director, Quantitative Clinical Pharmacology (QCP) Lead, Executive , Boston, Rhode Island
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