Senior Scientific Director, Modeling and Simulation
Company: Takeda Pharmaceutical
Posted on: November 12, 2021
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Senior Scientific Director, Modeling and Simulation
Are you looking for a patient-focused, innovation-driven company
that will inspire you and empower you to shine? Join us as a Senior
Scientific Director, Modeling and Simulation in our Cambridge, MA
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
As a Senior Scientific Director, Modeling and Simulation working on
the Quantitative Solutions -team, you will be empowered to provides
scientific leadership and high value modelling and simulation
strategies to support Takeda programs as a member of the QS team
and PTS organization by collaborating with DDU functions. - A
typical day will include:
Provides general scientific leadership and high value modelling and
simulation strategies to support Takeda programs as a member of the
QS team and PTS organization by collaborating with DDU functions,
Global Clinical Development Teams (GCDT), Experimental Medicine,
Therapeutic Area teams, and other relevant functional areas.
Responsible for impactful strategic scientific input and modeling
and simulation (M&S) technical expertise throughout the drug
Must possess the scientific, interpersonal, managerial, and strong
communication skills to understand, conduct, and deliver the
outcome of complex translational research, and M&S programs
utilizing both internal and external resources. Serves as a senior
member and mentor for QS, PTS and R&D demonstrating impact and
value of model based approaches during drug development.
Ensures quantitative methodologies are implemented and completed in
a timely manner to enable impactful and high quality decision
Responsible for input on design and incorporation of M&S
components within a scientifically sound quantitative development
plans and clinical study protocols.
Actively participates and provides mechanistic, empirical and
quantitative systems pharmacology (QSP) modelling support in design
of preclinical and clinical studies with M&S components which
may include data analysis and interpretation.
Conducts complex modelling and simulation exercises using
appropriate tools/software for the quantitative analysis task and
maintains in depth knowledge of mechanistic, complex PK-PD
modelling, systems pharmacology, clinical utility index modelling
and model based meta-analysis. Working knowledge of machine
learning and AI is highly desirable.
Manages emerging problems or issues relevant to M&S activities
while keeping leadership informed of critical issues in a timely
Maintains high level of competence as a user of computational
platforms such as NONMEM, MONOLIX, Phoenix, Berkeley Madonna,
GastroPlus, SimCyp and/or MatLab. Maintains competency in use of
data management tools such as R or S-Plus and has working
familiarity with Shiny or R-Studio.
Responsible for preparing, reviewing, and/or approval of sections
of global regulatory filings relevant to preclinical and clinical
modeling and simulation activities of assigned compounds including:
Investigational New Drug Applications (IND), Regulatory Briefing
Documents, Investigational Brochures (IB), Investigational
Medicinal Product Dossiers (IMPD), Common Technical Documents (CTD)
as the basis for New Drug Applications (NDA) in the U.S. and Market
Authorization Applications (MAA) in the EU, IND annual reports,
EMA/CHMP documents, and scientific white papers. Point of contact
for QCP-QS SOP and policy development.
Represents QS and Takeda in meetings with regulatory agencies and
health authorities if needed.
Provides mentoring in modeling and simulation to new staffs and
members of other functional areas and collaboratively interacts
with scientists from other functional areas, divisions, affiliates
and alliance partners.
Represents Takeda at external meetings and conferences as well as
establish the reputation of Takeda with the external experts and
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Ph.D. or equivalent higher degree +15 years of pharmacometrics,
clinical pharmacology, pharmacokinetic, DMPK, relevant engineering
fields, applied biomathematics, bioengineering or other relevant
experience is preferred
Educational degree in a relevant scientific area, e.g.,
Pharmacology, Pharmacokinetics, Pharmacodynamics, Drug Metabolism,
Pharmacy, Bioengineering, Mathematics, etc.
Significant drug development experience from a modelling and
simulation, DMPK, clinical pharmacology, perspective is
In depth, expert knowledge of mechanistic and QSP modelling,
pharmacometrics, pharmacokinetics and pharmacodynamics, -including
PK/PD data analysis and modelling techniques as well as
interpretation of complex data and statistical analyses.
Proficiency in R language and familiarity with scripting is highly
Strong knowledge of allied fields critical for drug development,
such as drug metabolism, pharmacology, toxicology, bioanalytical
chemistry, and pharmaceutical science.
Must have scientific and technical expertise as evidenced by
publications, patents, awards/honors and credibility at
professional societies. - Alternatively, must have evidence of
successful utilization of scientific and technical principles in
negotiation of project goals with internal management and/or
Thorough understanding of drug development and global regulatory
Takeda U.S. Vaccine Requirement:
Absent an approved religious or medical reason, all US office-based
and lab-based Takeda employees who work fully on-site or in a
hybrid model (as determined by Takeda) must be fully vaccinated to
work at a Takeda site or to engage with Takeda colleagues or anyone
else on behalf of Takeda. US field-based employees must be fully
vaccinated as a condition of employment, absent an approved
religious or medical reason. US employees who work at a Takeda
manufacturing facility, and those who work at a BioLife center or
BioLife lab, may be subject to different guidelines. If you are
contacted by a Takeda recruiter about your job application, we
encourage you to seek more information on the applicable guidelines
for the Business Unit/Function to which you have applied.
This job posting exclude Colorado applicants.
Access to transportation to attend various meetings held in
proximity to the Takeda offices.
Able to fly to various meetings at investigator, vendor or
regulatory agency sites.
Some international travel may be required
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health
Generous time off for vacation and the option to purchase
additional vacation days
Community Outreach Programs
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
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.
Keywords: Takeda Pharmaceutical, Hempstead , Senior Scientific Director, Modeling and Simulation, Executive , Hempstead, New York
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