Associate Director, Pediatric Immunology & Clinical Development

jj; Pennsylvania; On-site; USD 170,000 - 240,000; Full time

Job summary

Johnson & Johnson in Spring House, PA seeks an Associate Director for Clinical Immunology development with pediatric indications. You will support strategy, protocol design, development and execution of trials, and contribute to regulatory interactions.

You will provide scientific and clinical leadership to trial teams, oversee Phase 1–3 pediatric studies, monitor safety, and contribute to INDs and regulatory submissions. Travel up to 10% may be required.

Qualifications

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

Responsibilities

• Provides strategic input to pediatric drug development group.
• Provides scientific and clinical leadership to pediatric clinical trial teams.
• Responsible for design, execution, and reporting of Phase 1,2 and 3 pediatric clinical trials.
• Monitors safety of clinical trials and provides scientific leadership in the area of responsibility.
• Contributes to Integrated Study Plans and regulatory submissions.
• Collaborates with development teams to align pediatric strategy.
• Oversees preparation of clinical portions of regulatory submissions.
• Authors abstracts and manuscripts from trial data.
• Presents data to the organization at all levels.

Skills

Clinical Research

Regulatory Affairs

Leadership

Cross-functional teams

Education

MD or DO

Board Certification or Eligibility in Pediatrics or subspecialty

Job description

Johnson & Johnson in Spring House, PA seeks an Associate Director for Clinical Immunology development with pediatric indications. You will support strategy, protocol design, development and execution of trials, and contribute to regulatory interactions.

You will provide scientific and clinical leadership to trial teams, oversee Phase 1–3 pediatric studies, monitor safety, and contribute to INDs and regulatory submissions. Travel up to 10% may be required.