Study Responsible Physician- Neuroscience (pediatric Studies)

Johnson & Johnson Johnson & Johnson · Pharma · Beerse, Antwerp, Belgium

This role is for a Study Responsible Physician in Neuroscience (Pediatric Studies) at Johnson & Johnson. The physician will provide medical leadership, design, and execution of pediatric clinical studies, focusing on patient safety, data review, and collaboration with cross-functional teams. Responsibilities include medical monitoring, protocol development, adverse event evaluation, and contributing to regulatory submissions. Experience in neuroscience and pediatric drug development is preferred.

What you'd actually do

  1. Responsible for medical monitoring/reporting and company safety officer activities
  2. Works on clinical development plans, trial protocols and takes ownership of clinical study reports
  3. Evaluates adverse events (pre- and post-marketing) for relationship to treatment
  4. Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting related to study conduct or outcome
  5. May act as a medical contact at the company for health authorities concerning clinical/medical issues

Skills

Required

  • MD (or equivalent) in relevant area
  • Training or experience in neuroscience
  • Experience in pediatric drug development
  • Minimum of 1 year of experience conducting clinical trials in pharmaceutical, biotechnology, or CRO settings, with direct involvement in pediatric populations OR Minimum of 2 years of experience conducting clinical trials in an academic setting, with some focus on pediatric or adolescent patient populations
  • Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
  • Solid analytical and critical thinking skills

Nice to have

  • MD/PhD