Senior Consultant in Toxicology
This position requires prior recent experience within FDA
Aclairo PDG, Inc. consults to the pharmaceutical and biologic product industry in nonclinical (pharmacology and toxicology) clinical pharmacology and related regulatory areas. Our nonclinical consultation consists of strategic advice, overall program design, study placement and monitoring, regulatory document preparation, and position papers. Our consultants are located throughout the US and work virtually from their home offices. Our main office is in the Washington D.C. metro area.
Senior consultants in toxicology have more than 15 years of experience and a doctorate level degree. They are expected to have intimate knowledge of toxicological science, regulatory nonclinical knowledge, as well as extensive knowledge of drug/biologic development.
Aclairo is seeking specifically a senior consultant with FDA CDER or CBER experience. The successful applicant may be a seasoned reviewer, supervisor, or at the office level in the areas of pharmacology, toxicology, or pathology. Experience with other FDA Centers and worldwide health authorities a plus.
Professional Excellence
- Provides scientific and innovative advice with an advanced level of technical skill and insight.
- Provides regulatory insights across CDER divisions
- Demonstrates and clearly articulates an understanding of client needs
- Produces a high-quality work product that is acceptable, on time and within budget
- Effectively manages deadlines, multi-tasks and works well and remains calm under pressure
- Participates in business development activities
- Effectively communicates with clients and manages the client relationship where appropriate
- Engages directly or assists in the publication of relevant articles
- Demonstrates excellent communication skills, written and oral
Teamwork
- Manages assigned projects/tasks providing coordination and thought leadership
- May be responsible to help in the preparation of project plans and determination of task assignment
- Participates in the training and development of junior staff
- Models, promotes and demonstrates collegiality with all company employees
Personal Growth and Development
- Maintains current scientific and regulatory knowledge by initiating the appropriate internal or external educational/learning pursuits
- Ensures personal development goals are in place and carried out in agreed timeframe
Required Education and Skills
- Advanced degree in a life science or related field of study (PhD and/or DVM)
Contact:
Heath Thomas (HThomas@Aclairo.com)
Please include your CV and a cover letter.