Posted 4 months ago
Project Leader
AI Summary
Leads non-clinical drug development projects for an ophthalmology company, managing IND-enabling studies and pre-clinical regulatory requirements.
About this role
Project Leader
A Few Words About Us
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
This 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.
Qualifications
- ·Minimum of Bachelor’s Degree in Life Sciences or related field
Excellent understanding of (hands-on experience with) non-clinical drug development
- · At least 2-3 years of biotech or pharmaceutical industry experience
- · Experience designing and handling animal experiments
- · Ability to work and think independently
- · Experience interfacing with the FDA a plus but not required
- · Experience in ophthalmology a plus but not required
- · Experience managing a CRO team a plus
Additional Information
All your information will be kept confidential according to EEO guidelines.
Skills
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