Associate Director, Clinical Pharmacology
Company: Daiichi Sankyo, Inc.
Location: Basking Ridge
Posted on: January 24, 2023
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Job Description:
Join a Legacy of Innovation 110 Years and Counting!Daiichi
Sankyo Group is dedicated to the creation and supply of innovative
pharmaceutical therapies to improve standards of care and address
diversified, unmet medical needs of people globally by leveraging
our world-class science and technology. With more than 100 years of
scientific expertise and a presence in more than 20 countries,
Daiichi Sankyo and its 15,000 employees around the world draw upon
a rich legacy of innovation and a robust pipeline of promising new
medicines to help people. Under the Group's 2025 Vision to become a
"Global Pharma Innovator with Competitive Advantage in Oncology,"
Daiichi Sankyo is primarily focused on providing novel therapies in
oncology, as well as other research areas centered around rare
diseases and immune disorders.SummaryThe Associate Director will be
responsible for developing and implementing Clinical Pharmacology
and Modeling & Simulation plans from FIH to post
registration.Responsibilities include the development of Clinical
Pharmacology and Modeling and Simulation plans, design and lead
study teams to execute Clinical Pharmacology studies, conduct hands
on population PK and PKPD analyses and participate in regulatory
interactions and submissions representing the Clinical Pharmacology
and Pharmacometrics/ Quantitative Clinical Pharmacology function.
The incumbent will champion model-based drug development as an
active team member of clinical and development
teams.Responsibilities:Responsible for all aspects of clinical
pharmacology and biopharmaceutics studies; clinical pharmacology
project lead; supports Phase 2/3 clinical pharmacology objectives
with high-level supervision; participates in due diligence
activities and represents global function on study and project
teams.Produces independent writing for publications & regulatory
documents.Serves as a specialist in PK-PD and Pop PK-PD concepts,
phase 1-4 clinical studies, literature, and regulatory guidelines
and can conduct/develop PK-PD and Pop PK-PD analyses.Participates
in KOL and regulatory interactions at project level, interacts with
regional and global study and project team members, and to a
limited extent with senior management, and outside vendors; works
independently for all phases of studies.Qualifications: Successful
candidates will be able to meet the qualifications below with or
without a reasonable accommodation.Education Qualifications: (from
an accredited college or university)PhD in pharmacology or
pharmaceutical sciences required orPharmD with a clinical
pharmacology research fellowship requiredExperience
Qualifications:1 or More Years industry experience requiredDaiichi
Sankyo, Inc. is an equal opportunity/affirmative action employer.
Qualified applicants will receive consideration for employment
without regard to sex, gender identity, sexual orientation, race,
color, religion, national origin, disability, protected veteran
status, age, or any other characteristic protected by law.
Keywords: Daiichi Sankyo, Inc., Newark , Associate Director, Clinical Pharmacology, Executive , Basking Ridge, New Jersey
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