Job: Toxicologist, Camargo Pharmaceutical Services, Durham, NC
Camargo Pharmaceutical Services is excited to announce that we are now seeking a Toxicologist to join our growing nonclinical team. As a Toxicologist, you will provide 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 our clients. You 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 have demonstrated knowledge of the research process and direct research experience.
* You are familiar with FDA regulatory requirements and have written, edited, and formatted submission documentation for PIND packages and CTD nonclinical sections of INDs, NDAs, and other applications.
* 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.
What You’ll Do:
As the Toxicologist, you will work with other members of the project team to analyze the 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. You’ll serve as the lead nonclinical representative on project teams and be the primary nonclinical contact with Clients.
Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway. Drawing on our extensive understanding of the medication development process, we create unique, customized programs matched to specific needs. But we don’t just consult—we also have the resources and expertise to implement solutions. Our scientifically credible, comprehensive approach allows us to take a new product from concept through the full development lifecycle, addressing scientific, medical, commercial and regulatory strategies. Our cross-functional teams are made up of highly trained scientists, including an extensive team of PhDs across key life sciences, and a highly specialized team of pharmacokineticists. This depth, coupled with rigorous scientific literature reviews and access to priority and subscription databases, delivers unequalled technical and market insights.
* 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 (Blue Ash), Durham or Montreal (Quebec) office.