Vice President/Director,
Preclinical Operations
Position Summary:
- Manage preclinical safety assessment program for a portfolio of NCE's
- Generate and integrate preclinical data to support Investigational New Drug submissions
Location:
Boston Area
Functions:
- Conduct Due Diligence to support the selection of programs for the portfolio
- Interact directly with multidisciplinary teams to bring discovery candidates into development
- Design and conduct Toxicology/ADME/PK studies supporting IND submissions
- Assist in IND submission and the preparation of annual reports
- Ensure regulatory compliance
- Oversee selection/qualification of external vendors. Develop vendor contracts. As necessary monitor all activities of vendors
- Perform data analysis and prepare or review final reports for all preclinical studies
- Ensure scientific integrity of prelicnical studies
- Participate as an integral member of development team
Education:
Requires a PhD in a pharmacology/toxicology
Experience:
Minimum of 7 years experience in a related position in a pharmaceutical or biotech company
Skills:
- Expert knowledge of scientific principles and concepts
- Strong leadership and management skills
- Excellent teamwork and collaboration skills
- Effective process and project management skills
- Outstanding written and verbal communication skills
- Ability to multi-task as needed in a start-up environment
Inquiries for employment
Please direct all inquiries about this position to work@flexiontherapeutics.com.
