Associate Director, Quantitative Clinical Pharmacology (QCP) Lead
Company: Takeda Pharmaceutical
Location: Boston
Posted on: October 22, 2024
Job Description:
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in my employment application is true to the best of my
knowledge.Job DescriptionAre you looking for a patient-focused,
innovation-driven company that will inspire you and empower you to
shine? Join us as an 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.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 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.
- 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.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 & Experience
- 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-PDDesired 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 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.Desired behavioral
competencies:
- 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.This position is currently classified as "
hybrid" in accordance with Takeda's Hybrid and Remote Work
policy.Empowering Our People to ShineDiscover more at
takedajobs.comNo Phone Calls or Recruiters Please.#LI-JV2Takeda
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, Brookline , Associate Director, Quantitative Clinical Pharmacology (QCP) Lead, Healthcare , Boston, Massachusetts
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