Pediatric Immunology Clinical Strategy Leader

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

Job summary

Johnson & Johnson Innovation in Spring House, PA is seeking an Associate Director for Clinical Immunology products. This role supports strategy, protocol design, development, and execution across pediatric indications in immunology, rheumatology, infectious disease, dermatology, or gastroenterology.

The position involves input on regulatory interactions and document writing, with potential for direct line management and domestic/international travel.

Qualifications

• MD or DO is required.
• Board Certification or Eligibility in Pediatrics or Pediatric subspecialty (Immunology, Rheumatology, Infectious Disease, Dermatology, Gastroenterology, Pulmonology) is desirable.
• Experience in pharmaceutical drug development or clinical research is desirable.
• Ability to work in a matrix environment with cross functional teams.
• Strong leadership and influential abilities.
• Approximately 10% annual travel may be required.

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.
• Monitoring safety of clinical trials and providing scientific leadership.
• Contributes to Integrated Study Plans, protocols, and submission documents.
• Collaborates with development teams to align pediatric strategy.
• Oversees preparation of regulatory submissions (INDs, IBs, CTAs, BLAs).
• Authors abstracts/manuscripts on trial data.
• Presents data to organization at all levels.
• Builds relationships with opinion leaders and external alliances.
• Potential for direct line management.

Skills

Clinical Research

Regulatory Affairs

Leadership

Drug Development

Pediatrics Immunology

Education

MD or DO

Job description

Johnson & Johnson Innovation in Spring House, PA is seeking an Associate Director for Clinical Immunology products. This role supports strategy, protocol design, development, and execution across pediatric indications in immunology, rheumatology, infectious disease, dermatology, or gastroenterology.

The position involves input on regulatory interactions and document writing, with potential for direct line management and domestic/international travel.