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About Culture & Careers Toxicologist

Toxicologist

Location: Durham, NC

Type: Full Time

Minimum Experience: Mid Level

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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.

Requirements:

  • 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.

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About Camargo Pharmaceutical Services

We are a fast growing, global organization with a small company feel, comprised of high performing, multi-disciplinary, collaborative teams. We value independent thinking, learning and development (both personally and professionally), and provide the needed resources for you to reach your potential and goals. Camargo partners with companies in more than 25 countries worldwide and has led the largest percentage of 505(b)(2) submissions of any team submitting to the FDA—Camargo is the industry authority in 505(b)(2). Routinely holding three to six pre-IND meetings a month, Camargo has guided more than 200 FDA approvals and works with product developers across more than 25 countries.


Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.


Contact
Headquarters
9825 Kenwood Road,
Suite 203
Cincinnati, OH 45242
Durham Office
2505 Meridian Parkway,
Suite 150
Durham, NC 27713
Phone 513.561.3329
Toll Free 888.451.5708
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