Role Summary
The Pediatric Development Lead sits within Clinical Development, serving as the primary partner for asset development teams in shaping pediatric strategy and development plans, focusing on execution including co-authoring pediatric concepts and protocols and leading pediatric health authority submissions. The role is part of the Pediatrics Center of Excellence (CoE).
Responsibilities
- Co-author Pediatric concepts and protocols and drive successful pediatric health authority submissions.
- Partner with asset development teams to shape pediatric strategy and development plans.
- Collaborate across global Clinical Development to support pediatric programs within the Center of Excellence.
Qualifications
- Experience leading pediatric development strategy and regulatory submissions (pediatric populations).
- Strong collaboration across cross-functional teams in a global clinical development environment.
- Ability to navigate complex regulatory landscapes and design adaptive development plans.
Skills
- Pediatric development expertise
- Regulatory submission leadership
- Cross-functional collaboration
- Strategic planning and execution
Education
- Relevant advanced degree in life sciences or related field (e.g., MD, PhD, PharmD) preferred.
Additional Requirements
- Location: Madison, NJ or related location as specified; travel may be required based on program needs.