Account Executive, Product Sales
Stripe
Director, Toxicology and Immunology – Therapeutic Area
Kerr Dental
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $185,500 - $344,500 per year
Job Level
Lead
About the role
- Provide nonclinical regulatory toxicology expertise on R&D project teams supporting clinical trial initiation and registration for drug candidates
- Lead cross functional associates to develop and implement integrated nonclinical toxicology study plans
- Draft regulatory responses and required submission documentation
- Manage project communication strategy within PCS and Novartis
- Design, integrate and interpret nonclinical safety assessment programs and assess impact to drug development and timelines
- Represent PCS on cross functional R&D project teams to design compliant and scientifically relevant nonclinical safety packages
- Negotiate with Global Health Authorities regarding safety issues and acceptability of nonclinical safety packages
- Author nonclinical safety sections of internal and regulatory documents
- Evaluate in/out-licensing opportunities and perform technical due diligence upon request
- Participate or lead cross-functional groups and internal initiatives focused on nonclinical safety topics
- Mentor colleagues on drug development strategy and project-related matters
Requirements
- Minimum of 5 years experience as a nonclinical safety Project Team member
- 8+ years experience in a nonclinical drug development scientific discipline
- Demonstrated experience in the preclinical development of small molecule, biotherapeutics and/or gene and cell therapies
- Demonstrated experience in direct or written communication of strategy and data to global health authorities
- Knowledge of drug development strategy for immunomodulatory drugs
- Leadership in cross-industry organizations
- Excellent interpersonal, leadership, organizational, oral and written communication, influencing, planning and time management skills
- Highly efficient, self-motivated, flexible and able to work independently under time constraints
- Ability to focus and work on several projects simultaneously and manage conflicting expectations in a matrix environment
- Ability to mentor and coach
