Pediatric Immunology Clinical Development Lead

INAAP; Northern (KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson is seeking an Associate Director of Clinical Development, Immunology, to lead pediatric development programs across indications such as Pediatric Immunology, Rheumatology, Infectious Disease, Dermatology, or Gastroenterology. This role supports strategy, protocol design, development, and regulatory interactions.

You will guide trial design, oversee multi-phase studies, and contribute to IND submissions while mentoring trial teams and liaising with cross-functional partners to

Qualifications

• MD or DO is required.
• Board Certification or Eligibility in Pediatrics or Pediatric subspecialty is highly desirable.
• Experience in pharmaceutical drug development or clinical research is highly desirable.
• Ability to work in a matrix environment with cross functional teams is essential.
• Strong leadership skills and the ability to influence is necessary.
• Approximately 10% annual travel may be required (domestic and international).

Responsibilities

• Provides strategic input to pediatric drug development group.
• Provides scientific & clinical leadership to pediatric clinical trial teams.
• Responsible for design, execution, and reporting of Phase 1,2 and 3 pediatric clinical trials.
• Responsible for monitoring safety of clinical trials and providing scientific leadership in the area of responsibility.
• Contributes to the development of the Integrated Study Plans and study summaries, IND submissions, and technical reports.
• Collaborates with early and late development clinical teams and Compound Development Teams to align pediatric strategy.
• Oversees the preparation of clinical portions of Immunology project INDs, IBs, CTAs, BLAs and other regulatory submissions.
• Authorship of abstracts and manuscripts for publication based on clinical trial data.
• Presents data and scientific information to the organization at all levels.
• Builds credible relationships with opinion leaders and External alliances for partnered products when relevant
• Potential for direct line management responsibility

Skills

Clinical leadership

Pediatrics expertise

Regulatory affairs

Team collaboration

Education

MD/DO

Board Certification or Eligibility in Pediatrics

Job description

Johnson & Johnson is seeking an Associate Director of Clinical Development, Immunology, to lead pediatric development programs across indications such as Pediatric Immunology, Rheumatology, Infectious Disease, Dermatology, or Gastroenterology. This role supports strategy, protocol design, development, and regulatory interactions.

You will guide trial design, oversee multi-phase studies, and contribute to IND submissions while mentoring trial teams and liaising with cross-functional partners to