Clinical Pharmacologist/Senior Clinical Pharmacologist, Quantitative Clinical Pharmacology
Company: Takeda Pharmaceutical
Posted on: January 19, 2023
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Are you looking for a patient-focused company that will inspire you
and support your career? If so, be empowered to take charge of your
future at Takeda. Join us as a Clinical Pharmacologist/Senior
Clinical Pharmacologist , Quantitative Clinical Pharmacology in our
Here, everyone matters and you will be a vital contributor to our
inspiring, bold mission. As a Clinical Pharmacologist/Senior
Clinical Pharmacologist working on the team, you will be empowered
to manage strategic, scientific and operational aspects of multiple
drug development programs from the clinical pharmacology
perspective, and a typical day will include:
- Leads strategic, scientific and operational aspects of multiple
drug development programs 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
- 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.
- Provides scientific and strategic leadership as the Clinical
Pharmacology Lead for multiple programs on Global Program Teams and
associated scientific and operational sub-teams.
- Charged with integrating pharmacokinetic, pharmacodynamic,
efficacy and safety data from multiple sources to optimize dosing
for different populations across the development continuum.
- Responsible for drafting and executing clinical pharmacology
plans, including integration of M&S, in collaboration with key
partner functions (e.g., SQS, QS and DMPK). Ensures that M&S
(Modeling and Simulation) plans are fully integrated with the
larger program development plans to enable impactful Model-Informed
Drug Development (MIDD) practices.
- Works closely with colleagues in DSI, QS, and with external
partners to ensure advanced modeling and simulation approaches
(e.g., QSP, MBMA) inform internal decisions and external regulatory
- 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 for
regulatory submissions (such as IB, CTA, CTD Module 2 documents,
- Oversees and/or independently performs 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
- Represents Clinical Pharmacology in meetings with global
regulatory agencies for assigned programs.
- Participates as a member of Business Development due diligence,
- Leads infrastructure initiatives and/ or cross-functional best
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Clinical Pharmacologist Level: Ph.D or Pharm D. w/ 0+ years or
M.S. w/ +2 years or B.S. w/ +5 years of pharmacometrics, clinical
pharmacology, pharmacokinetic, or other relevant experience.
- Senior Clinical Pharmacologist Level: Ph.D w/ or Pharm D. w/ 3+
years or M.S. w/ 4+ years or B.S. w/ 6+ years of experience in
pharmacometrics, clinical pharmacology, pharmacokinetic, or other
relevant experience Location and Salary Information:
This position is currently classified as "hybrid" in accordance
with Takeda's Hybrid and Remote Work policy."
Base Salary Range: $130,200 to $186,000, based on candidate
professional experience level. Employees may also be eligible for
Short Term and Long-Term Incentive benefits as well. Employees are
eligible to participate in Medical, Dental, Vision, Life Insurance,
401(k), Charitable Contribution Match, Holidays, Personal Days &
Vacation, Tuition Reimbursement Program and Paid Volunteer Time
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.
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
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs Empowering Our People to Shine
Learn more at .
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.
USA - MA - Cambridge
Keywords: Takeda Pharmaceutical, Cambridge , Clinical Pharmacologist/Senior Clinical Pharmacologist, Quantitative Clinical Pharmacology, Other , Cambridge, Massachusetts
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