Clinical Pharmacology Lead - Cell Therapies
Company: Takeda Pharmaceuticals International GmbH
Location: Cambridge
Posted on: February 20, 2021
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Job Description:
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. Clinical
Pharmacology Lead - Cell Therapies 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.
Clinical Pharmacology Lead - Cell Therapies Job ID R0025311 Date
posted 12/10/2020 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 Clinical Pharmacology
Lead - Cell Therapy 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:
As a Clinical Pharmacology Lead for Cell Therapies, you will
support the development of these novel therapeutic modalities from
early phase to late phase and regulatory submission. You will also
be charged with characterization and integration of knowledge
related to the kinetics of human cellular distribution, expansion,
persistence, and measures related to efficacy and safety. You will
be responsible for supporting dose level and regimen
recommendations, identification of genetic and demographic factors
that impact efficacy and safety, and other clinical and regulatory
support for Takeda's cell therapy programs. You will develop
clinical pharmacology strategies, execute clinical pharmacology
studies, and perform dose-exposure-response analyses within the
context of multi-scale, physiologic systems in the cell therapy
context. The position's objectives also include comprehensive
understanding and interpretation of preclinical packages, protocol
development, data interpretation, study report completion, and
communication of results with recommendations on future development
decisions.
This position will report to Head of Cell Therapy Clinical
Pharmacology & Modeling, with 100% of efforts devoted to cell
therapy development. All efforts will be directed toward
progression of cell therapies into and through clinical development
with the ultimate objective of global regulatory approval.
ACCOUNTABILITIES: This role will be expected to be the primary
point of accountability at the asset level for assigned programs
and will provide scientific, and quantitative input as the Clinical
Pharmacology Lead on the Global Program Teams, and associated
scientific and operational sub-teams. Responsible for the design
and implementation of the Clinical Pharmacology plans using
traditional and model informed drug development approaches and will
manage the clinical study process from protocol development to
final study reporting. L eads dose justification, reinfusion
strategy, CKPD based assessments, immunogenicity by integrating
cellular kinetics, pharmacodynamics, product and patient
characteristics throughout clinical development in close
collaboration with key functions. Conduct or oversee
non-compartmental analysis (NCA), cellular kinetic
(CK)/pharmacodynamic (PD) and dose-exposure-response analyses to
support dose selection and trial design at all stages of drug
development, internal go/no decision-making, regulatory submission
documents, and publications. Responsible for clinical pharmacology
contributions to all regulatory documents including Investigator
Brochures, protocols, pre IND, EOP1/2 and BLA meetings. Takes a
lead role in writing and reviewing responses to pharmacology
queries from regulatory agencies. During the pre-clinical stages of
product development works with research teams to ensure
quantitative mechanistic understanding and preclinical PK-PD
knowledge to justify human dose and route of administration.
Provide input to optimize in vitro & preclinical CKPD data
supporting the dose & advancement of programs into clinical
development and the submission of Investigational New Drug
applications. Accountable for ensuring that there are valid methods
for measuring cellular kinetics and immunogenicity in the clinic.
Manage program timelines for clinical pharmacology components and
related matters; manage budgets to meet or exceed time, quality,
and fiscal objectives. Assure cross-functional alignment for
Clinical Pharmacology activities with other functional areas
involved in clinical development programs, within Takeda,
intercompany interfaces, and partnerships. Initiate and manage
external collaborations with leaders in clinical development and
Key Opinion Leaders. Mentors and coaches junior staff, promoting
Takeda's values and behaviors EDUCATION, EXPERIENCE, KNOWLEDGE AND
SKILLS: Education: PhD in Clinical Pharmacology, Pharmacokinetics,
Pharmacometrics, Engineering or other disciplines related to
quantitative pharmacology Required: Minimum of 8 years of clinical
pharmacology/modeling experience in the pharmaceutical/
biotechnology industry covering early to late phase clinical
development Experience with and/or strong interest in Cell Therapy,
Oncology or Immunooncology Ability to apply pharmacokinetic and
pharmacokinetic-pharmacodynamic concepts, including modeling and
simulation to clinical trial design, and address clinical & product
related questions. . Demonstrated expertise in the design, analysis
and reporting of clinical pharmacology studies. The candidate must
be competent in the use of industry-standard computational software
for noncompartmental, physiological and multi-scale modeling, and
Bayesian analyses and simulation. Track record of publications and
contributions to INDs, NDAs/BLAs, with various regulatory agencies
& defending clinical pharmacology packages. Strong technical
proficiency in pharmacokinetic software (e.g WinNonlin, NONMEM,
Monolix, R, etc.) and modeling. Ability in managing multiple
programs Knowledge and Skills: Excellent written and verbal
communication, organizational and interpersonal skills, be a strong
team player and fully at ease in a matrix environment. Ability to
advance multiple projects in a fast paced "biotech like"
environment; drive initiatives, lessons learned, and best practices
Ability to work in a demanding environment with aggressive project
timelines Demonstrates a breadth of diverse leadership experiences
and capabilities including: the ability to influence and
collaborate with peers, develop and coach others, oversee and guide
the work of other colleagues to achieve meaningful outcomes and
create business impact. TRAVEL REQUIREMENTS: Willingness to travel
to various meetings or client sites, including overnight trips.
Some international travel may be required Requires approximately
10% travel WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and
Annual Retirement Contribution Plan Tuition reimbursement Company
match of charitable contributions Health & Wellness programs
including onsite flu shots and health screenings 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, Cambridge , Clinical Pharmacology Lead - Cell Therapies, Healthcare , Cambridge, Massachusetts
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