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Assoc Dir Clinical Pharmacology QCP

Employer
Daiichi Sankyo
Location
Basking Ridge, New Jersey, United States
Start date
Sep 8, 2019

View more

Discipline
Clinical, Clinical Research, Science/R&D
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country

Job Details

Job Summary:
The 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:
Education: Bachelor's degree and Master's degree, MD or Ph.D.in pharmacology or pharmaceutical sciences, or a PharmD with a clinical pharmacology research fellowship.

Experience: 5+ years industry experience

Job Title
Assoc Dir Clinical Pharmacology QCP

City
Basking Ridge

Functional Area
QCP

State
New Jersey

Company

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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.

For more information, please visit: www.daiichisankyo.com.

Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com.

STOCK EXCHANGE: Tokyo Stock Exchange

STOCK SYMBOL: 4568

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Company info
Website
Phone
(908) 992-6400
Location
211 Mt. Airy Road
Basking Ridge
New Jersey
07920
United States

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