Study Responsible Physician- Neuroscience (Pediatric Studies)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – MD

Job Category:

People Leader

All Job Posting Locations:

Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson, is recruiting for a Study Responsible Physician- Neuroscience (Pediatric Studies) to be based at one of our sites in Titusville, NJ or Spring House, PA.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Our Neuroscience team tackles the world’s toughest brain health challenges including multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, myasthenia gravis, epilepsy, major depressive disorder, bipolar disorder, schizophrenia, and autism. This patient-focused team helps address some of the most complex diseases of our time.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

The Neuroscience Therapeutic Area (TA) Study Responsible Physician (SRP) is accountable for the medical leadership, design, and execution of pediatric clinical studies within the Neuroscience TA clinical portfolio. The SRP is a core member of the cross functional study team, working in close partnership with the Clinical Lead and providing expert pediatric medical and scientific leadership across all phases of study delivery.

The SRP contributes substantively to the clinical development plan, with a particular focus on pediatric strategy, and leads or supports the development of pediatrics focused clinical trial protocols, associated trial materials, investigator training content, clinical study reports, and key documents supporting regulatory submissions.

A central responsibility of the SRP is the medical oversight of patient safety, including ongoing, in depth review of clinical data, adverse events, medical histories, and protocol deviations. The SRP engages in frequent site interactions to ensure protocol compliance, high quality data, and the protection of pediatric trial participants, while providing medical guidance to address emerging safety or feasibility issues.

The SRP operates within a highly matrixed environment, collaborating closely with project management, regulatory affairs, clinical operations, data management, biostatistics, medical writing, global safety, quality and compliance, clinical supplies, legal, finance, global medical affairs, and other scientific and business partners. As needed, the SRP may also contribute to the evaluation of scientific and clinical development opportunities within the Neuroscience TA.

RESPONSIBILITIES:

• Responsible for medical monitoring/reporting and company safety officer activities

• Works on clinical development plans, trial protocols and takes ownership of clinical study reports

• Evaluates adverse events (pre- and post-marketing) for relationship to treatment

• Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting related to study conduct or outcome

• May act as a medical contact at the company for health authorities concerning clinical/medical issues

• Interprets, reports, and prepares oral and written results of product