The Director of Pharmacology and Toxicology is an experienced drug development scientist who will oversee the development and execution of nonclinical programs from research to late stage development including regulatory meetings, IND, market applications and post marketing commitments. Responsibilities include design and oversight of nonclinical programs for regulatory submission. Experience in integrated strategic regulatory writing and ability to work in cross functional and departmental teams is required. Development experience with different drug modalities including new molecular entities and gene therapy is a plus.
Essential Duties and responsibilities
- Scientific coordination of nonclinical study programs to support development
- Portfolio management of development programs with Nonclinical Operations
- Provide strategic nonclinical expertise to cross-functional teams.
- Scientifically design, manage and finalize the nonclinical portfolio of studies, both exploratory and GLP-compliant while coordinating with Nonclinical Operations and Study Monitors
- Provide analysis and interpretation of nonclinical results and integrate with the development program
- Communicate nonclinical safety findings to cross-functional teams, with appropriate perspective
- Author and review the nonclinical component of regulatory submissions with cross functional data integration
- Prepare for and participate in regulatory agency interactions
- Potential management of departmental scientists.
Core Competencies, Knowledge and Skill Requirements
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
- GLP compliance
- SEND database
- Knowledge and integration of international nonclinical guidance
- FDA, EU, MHRA, PMDA and ROW regulatory experience is a plus
Communication & Interpersonal Skills
- Excellent verbal and written communication skills
- Ability to effectively collaborate in a dynamic environment
- PhD in Pharmacology and Toxicology or equivalent degree
- 10+ years of experience in the pharmaceutical industry with experience in Pharmacology and Toxicology.
Licenses or Certifications
- Diplomate of American Board of Toxicology is not required but will be considered
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)
- Ability to work on a computer for extended periods of time.
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds.
- Travel requirements may include travel to study sites, regulatory meetings, conferences or other job-related visits.