Director, Nonclinical Development
Position Overview: Lead nonclinical development for a global pharmaceutical company committed to improving healthcare access through innovative solutions. This role combines strategic leadership, scientific expertise, and regulatory insight to advance product development.
Key Responsibilities:
- Direct nonclinical development activities including team management and strategic planning
- Develop regulatory strategies and oversee experimental design
- Review and approve preclinical protocols and study reports
- Communicate findings to stakeholders and regulatory authorities
- Oversee regulatory documentation for product development
- Provide scientific expertise across departments
- Conduct toxicological risk assessments
- Manage departmental resources and budget
Required Qualifications: Education & Experience (one of the following):
- Bachelor's degree with 15+ years relevant experience
- Advanced degree (PhD, DVM, PharmD preferred) with 10+ years pharmaceutical experience
Technical Requirements:
- Expert knowledge of pharmaceutical development and regulatory requirements
- In-depth understanding of GMP, GLP, GCP
- Experience with global regulatory processes
- Strong background in product development and analytical sciences
Leadership Requirements:
- Proven team management experience
- Strategic planning and execution abilities
- Strong project leadership skills
- Budget management experience
Core Competencies:
- Scientific writing and technical communication
- Problem-solving and analytical thinking
- Cross-functional collaboration
- Regulatory strategy development
- Strategic planning