Senior Scientific Director/Scientific Director, Quantitative
Company: Takeda Pharmaceuticals International GmbH
Posted on: January 15, 2021
The health and safety of our employees and candidates is very
important to us. Due to the current situation related to the
Coronavirus (COVID-19), we're leveraging our digital capabilities
to ensure we can continue to recruit top talent at Takeda. As your
application progresses, you may be asked to use one of our digital
tools to help you through your recruitment journey. If so, one of
our colleagues will explain how these tools will be used during the
recruitment process. Thank you. *Please be aware of an Identity
Theft Scheme targeting individuals seeking jobs with Takeda and
other employers. See below or here for more info. Senior Scientific
Director/Scientific Director, Quantitative Clinical Pharmacology
Takeda fosters a collaborative and stimulating work environment
filled with opportunity and the chance to make a difference in
people's lives. It is a workplace driven by integrity, one of
Takeda's long-held values that extends to both the patients we
serve and our employees who develop and deliver medicines. Across
our company, Takeda employees bring together diverse strengths that
together create a stronger whole. As one of the world's leading
biopharmaceutical companies, Takeda is committed to bringing Better
Health and a Brighter future to people worldwide. We aspire to
bring our leadership in translating science into life-changing
medicines to the next level, in our core focus areas; oncology,
gastroenterology, neuroscience, rare diseases, plasma-derived
therapies, and vaccines. The Greater Boston Area is headquarters to
many of our Global and US business units. We are a passionate team
doing important work that impacts patients' lives. If you are
driven to create better health and a brighter future, join us!
Success What makes a successful member of our team? Check out the
traits we're looking for and see if you have the right mix. Life at
Takeda A Global Top Employer Recognized for our culture and way of
working, we're one of only select companies to receive Top Global
Employer -- status for 2020. Senior Scientific Director/Scientific
Director, Quantitative Clinical Pharmacology Job ID R0019346 Date
posted 05/04/2020 Location Boston, Massachusetts 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/Scientific Director, Quantitative Clinical Pharmacology 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
- The Senior Scientific Director/Scientific Director manages
strategic, scientific and operational aspects of multiple drug
development programs from the clinical pharmacology perspective
with a high level of technical and strategic independence.
- Serves as the Global Clinical Pharmacology Lead for assets
across phases 1-4 of development with a high level of technical and
strategic independence. Works closely with functional experts
across the R&D organization, such QS, Research, Biostatistics,
Regulatory Affairs, DMPK, Pharm Sci, and Clinical Science providing
leadership and guidance in clinical pharmacology activities.
- Contributes to departmental management through program reviews
and collaborative decision-making, and leads infrastructure / best
- Supervises and mentors junior staff providing professional and
career development. ACCOUNTABILITIES
- Provides scientific and strategic leadership as the Clinical
Pharmacology Lead for multiple programs on Global Program Teams and
associated scientific and operational sub-teams.
- Responsible for drafting and executing clinical pharmacology
plans, including integration of M&S, in collaboration with key
partner functions (e.g., QS and DMPK). Ensures that M&S plans
are fully integrated with the overall clinical pharmacology plans
to enable Model-Informed Drug Development (MIDD).
- Works closely with colleagues in QS to ensure strategic
integration of advanced modeling and simulation approaches (e.g.,
QSP, MBMA) across the development continuum to inform internal
decisions and external regulatory interactions.
- Creates or assists in the preparation of protocol synopses,
oversees program execution including protocol conduct, data
analysis and reporting.
- Responsible for clinical pharmacology summary documents (such
as IB, CTA, CTD Module 2 documents, product labeling).
- Oversee and/or independently perform PK/PD analyses including
the interpretation of PK/PD data and associated statistical
analyses in close partnership with external CRO partners.
- Maintains a high standard for good clinical practice,
compliance and ethics.
- Mentors junior staff to ensure they value scientific
- Represents Clinical Pharmacology in meetings with global
regulatory agencies for his/her assigned programs.
- Participates as a member of Business Development due diligence,
- Leads infrastructure initiatives and/ or cross-functional best
practice initiatives. CORE ELEMENTS RELATED TO THIS ROLE
- This role will be expected to be the primary point of
accountability in QCP at the asset level for high complexity
programs across multiple therapeutic modalities with a high level
of technical and strategic independence as the Clinical
Pharmacology Lead on the respective Global Program Teams and
associated scientific and operational sub-teams.
- Senior Scientific Director, QCP has extensive experience and is
an acknowledged technical expert and thought leader within Takeda
who provides strategic scientific leadership, project planning, and
decision making from a clinical pharmacology perspective with a
strong enterprise mindset. S/he will thus be expected to lead
infrastructure and/ or best practice initiatives.
- Externally recognized for scientific leadership in quantitative
clinical pharmacology demonstrating a sustained record of
scientific productivity in the field of clinical pharmacology, as
evidenced by the development and/or implementation of numerous new
technical strategies, methods, processes and publications.
DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise
- Demonstrated expertise in application of PK/PD, modeling and
simulation, and use of clinical biomarkers for decision
- Demonstrated scientific and technical expertise through
publications, patents, awards/honors or credibility at professional
societies. Strong knowledge of allied fields critical for drug
development, such as drug metabolism, pharmacology, toxicology,
bioanalytical chemistry, and pharmaceutical science.
- Demonstrated experience with design and analysis of clinical
pharmacology studies. Leadership
- Demonstrated experience with design and execution of global
clinical pharmacology programs and associated regulatory
- Effective at building alliances across functions.
- Excellent interpersonal communication skills, able to drive
global collaborations in cross-functional, multi-cultural
- Excellent oral and written communication skills, including
writing, reviewing and editing scientific documents.
- Ability to effectively influence colleagues and
multi-disciplinary project teams. Decision-making and Autonomy
- High level of technical and strategic independence in driving
all clinical pharmacology aspects of program strategy and
associated trial designs, analysis plans and regulatory
documentation, and interpretation and communication of
- Accountable for planning, budgeting/ resourcing and
prioritization decisions related to all QCP deliverables for
programs in the assigned section of the portfolio.
- Serves as the sole representative of QCP both internally at
GPT/ CST meetings and externally at worldwide meetings with
regulatory agencies and Advisory Board Meetings. EDUCATION,
BEHAVIORAL COMPETENCIES AND SKILLS:
- Ph.D or Pharm D. w/ +10-15 years or M.S. w/ +15-20 years or
B.S. w/ +20-25 years of pharmacometrics, clinical pharmacology,
pharmacokinetic, or other relevant experience. WHAT TAKEDA CAN
- 401(k) with company match and Annual Retirement Contribution
- Tuition reimbursement Company match of charitable
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days Check out where you could be
working if you apply. Job Seekers: Protect yourself against
identity theft Please be aware there are instances of identity
thieves posting Takeda-branded jobs and posing as employees to
steal personal information. They visit job-related websites and
invite candidates to online chats. During the chat, they press job
seekers to provide bank account information and Social Security
numbers. Copyright 1995-2019 Takeda Pharmaceutical Company Limited.
All rights reserved.
Keywords: Takeda Pharmaceuticals International GmbH, Boston , Senior Scientific Director/Scientific Director, Quantitative, Executive , Boston, Massachusetts
Didn't find what you're looking for? Search again!