Pediatric Immunology Clinical Development Lead

Johnson & Johnson Innovative Medicine; Spring House (PA); On-site; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is seeking an Associate Director for Clinical Immunology products with pediatric indications. You will shape strategy, design trials, and contribute to regulatory submissions, influencing development across multiple pediatric immunology domains.

Role involves leading cross-functional teams, ensuring safety and scientific rigor, and advancing INDs and related regulatory documents while collaborating with internal and external partners.

Qualifications

• MD or DO is required.
• Board Certification or Eligibility in Pediatrics or Pediatric subspecialty (Immunology, Rheumatology, Infectious Disease, Dermatology, Gastroenterology, Pulmonology) is highly desirable.
• Experience in pharmaceutical drug development or clinical research is desirable.

Responsibilities

• Provide strategic input to pediatric drug development group.
• Provide scientific and clinical leadership to pediatric clinical trial teams.
• Design, execute, and report Phase 1, 2 and 3 pediatric clinical trials.
• Monitor safety of clinical trials and provide scientific leadership.
• Develop Integrated Study Plans, protocols, and regulatory submissions (INDs, IBs, CTAs, BLAs).
• Present data and scientific information to the organization at all levels.

Skills

Clinical trial leadership

Regulatory submissions

Cross-functional collaboration

Leadership and influence

Education

MD or DO required

Board Certification in Pediatrics or subspecialty desirable

Job description

Johnson & Johnson Innovative Medicine is seeking an Associate Director for Clinical Immunology products with pediatric indications. You will shape strategy, design trials, and contribute to regulatory submissions, influencing development across multiple pediatric immunology domains.

Role involves leading cross-functional teams, ensuring safety and scientific rigor, and advancing INDs and related regulatory documents while collaborating with internal and external partners.