Location: Durham, NC
Type: Full Time
Minimum Experience: Mid Level
Camargo Pharmaceutical Services is excited to announce that we are now seeking a Toxicologist. The Toxicologist provides scientific and regulatory support in nonclinical/toxicology data review, designing non-GLP and GLP protocols, writing/reviewing nonclinical sections of regulatory submissions (e.g., CTD sections for INDs and NDAs), and contracting/managing/on-site and off-site monitoring/reporting nonclinical studies on behalf of Clients. The Toxicologist will interact with clients on a regular basis to review and discuss projects and will interact with FDA as part of drug development meetings.
Who You Are:
- You love working with people. You are collaborative, upbeat, and optimistic.
- Operational excellence and providing outstanding internal and external customer service are second nature to you.
- You are a problem solver with a can-do, roll-up-your-sleeves spirit.
- You are exceptionally organized, detail-oriented and self-directed.
- You are a proactive and clear communicator.
What You'll Do:
As the Toxicologist you will work with other members of the team and project team scientists to analyze Sponsor’s drug and clinical indication, perform gap analysis on their existing nonclinical data, and develop nonclinical programs to support clinical development, including appropriate pharmacology, pharmacokinetic, and toxicology studies. The Toxicologist will serve as the lead nonclinical representative on project teams and be the primary nonclinical contact with Clients. This position is familiar with FDA regulatory requirements and works with a cross-functional drug development team to write, edit and format submission documentation to ensure high-quality PIND packages, and CTD nonclinical sections of INDs, NDAs, and other applications.
- Knowledge and skills at a level normally acquired through the completion of a Master’s or PhD in Toxicology or related field with at least 3 years of industry experience required, respectively.
- Demonstrated knowledge of FDA drug regulations required.
- FDA drug regulatory submissions experience (eg, writing nonclinical CTD sections) is highly preferred.
- Demonstrated scientific writing and editing skills.
- Ability to work collaboratively in a team environment, including global companies and sponsors.
This position is based in either our Cincinnati or Durham office.