Manager, Experimental Medicine at Edison

Job Description

Job Summary:
We are currently seeking a Manager, Experimental Medicine in Edison, NJ. This position will contribute to the design and implementation of early development studies, the submission of documents; regulatory meetings; and KOL interactions. This position demonstrates basic knowledge of standard FIH designs in healthy volunteers and patients; pharmacokinetics, pharmacodynamics, pharmacogenomics, and biomarkers analysis; regulatory guidelines for design and execution of early development studies; and preclinical pharmacology and MOA of drug candidates.

Responsibilities:
In this position, you will contribute to the design and conduct of studies in healthy volunteers or patients of best in class compounds
Contribute to the preparation of various regulatory documents (pre-IND briefing book, IB, protocols/amendments, CSRs etc.) and material for KOL interactions
Take part in meetings with regulatory authorities as observer and in interactions with KOL

Job Requirements

PharmD, PhD, MD, or equivalent
Industry experience not required
Postgraduate training and/or related specialty training (for MD) in TA or past successes, highly desirable

Daiichi Sankyo, Inc. is an Equal Opportunity Employer - M/F/D/V
Country: USA, State: New Jersey, City: Edison, Company: Daiichi Sankyo, Inc..