Biology, Biotech and Pharmaceutical, Clinical Practices/Protocols, Contract Research Organization (CRO), Drug Development, FDA (Food and Drug Administration), FDA Requirements, Management Consulting, Ophthalmology, Pre-Clinical, Research & Development (R&D), Safety Pharmacology, Team Lead/Manager, Toxicology Research
LOCATION
Alpharetta, Georgia
POSTED
Today
Project LeaderThis position will be based in Alpharetta Georgia for a growing ophthalmology company. It is a Sr. Manager, Director, or Sr. Director level role reporting to the Vice President of R&D. The client will offer relocation assistance if necessary.The Project Leader of Non-Clinical Development will be responsible for all aspects of drug development that involve moving a drug forward into the clinic (e.g. IND). Candidate should have a broad experience and hands-on drug development expertise with respect to design, monitoring, issue management and overall consultancy for PK/TK, metabolism, safety pharmacology and toxicology studies. The ideal candidate will understand pre-clinical FDA regulatory requirements.QualificationsMinimum of Bachelor's Degree in Life Sciences or related fieldExcellent understanding of (hands-on experience with) non-clinical drug developmentAt least 2-3 years of biotech or pharmaceutical industry experienceExperience designing and handling animal experimentsAbility to work and think independentlyExperience interfacing with the FDA a plus but not requiredExperience in ophthalmology a plus but not requiredExperience managing a CRO team a plusAll your information will be kept confidential according to EEO guidelines.