Director, Clinical Pharmacology

Location
Basking Ridge, New Jersey, United States
Posted
Oct 02, 2020
Ref
10230BR
Hotbed
Pharm Country
Required Education
Masters Degree/MBA
Position Type
Full time
Join a Legacy of Innovation 110 Years & Counting!

With over 100 years of scientific expertise & a presence in more than 20 countries, Daiichi Sankyo & its 15,000 employees around the world draw upon a rich legacy of innovation & a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension & thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research & development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart & kidney diseases, & other rare diseases.

Job Summary:

The primary responsibilities of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 studies, support Phase 2/3 studies, represent function on study and project teams, and participate in and contribute to regulatory and KOL meetings. This position requires significant understanding of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of the drug. This position effectively works independently for all phases of studies and participates in KOL and regulatory interactions at project level, and interacts with regional and global project team members, senior management, and outside vendors.

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

Mentors direct reports and department; responsible for performance management and development of a limited number of employees

Responsible for all aspects of all 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

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

Bachelor's degree and Master's degree, PhD or PharmD

7+ years industry experience

Daiichi 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.

Job Title
Director, Clinical Pharmacology

City
Basking Ridge

Functional Area
QCP

State
New Jersey