Project Leader

Integrated Resources Inc.; Alpharetta (GA); On-site; USD 100,000 - 160,000; Full time

Job summary

A leading staffing firm seeks a Project Leader of Non-Clinical Development for a growing ophthalmology company in Alpharetta, Georgia. This senior role requires a strong understanding of drug development and regulatory experience, with opportunities for relocation assistance.

Qualifications

• Minimum of Bachelor’s Degree in Life Sciences or related field.
• 2-3 years of biotech or pharmaceutical industry experience.
• Experience interfacing with the FDA a plus.

Responsibilities

• Responsible for all aspects of drug development moving forward into the clinic.
• Oversee design, monitoring, and issue management for drug studies.
• Understand pre-clinical FDA regulatory requirements.

Skills

Hands-on experience with non-clinical drug development

Ability to work and think independently

Education

Bachelor’s Degree in Life Sciences or related field

Tools

Experience designing and handling animal experiments

Experience managing a CRO team

Job description

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.

Job Description

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.