Director, Study Responsible Physician, Clinical Development, Neuroscience

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 https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – MD

Job Category:

Scientific/Technology

All Job Posting Locations:

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

Job Description:

JOB DESCRIPTION

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 Alzheimer’s disease, Parkinson’s disease, myasthenia gravis, major depressive disorder, bipolar disorder, and schizophrenia. 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 Study Responsible Physician (SRP) is responsible for design and execution of Ph3 studies in neurologic disorders. The SRP is a critical member of a cross-functional clinical team led by a Clinical Lead, and provides active medical and scientific contribution to the team. The SRP provides input and helps with the clinical development plan, the development of the clinical trial protocol, clinical trial materials including protocol training, content of clinical study reports and relevant documents for regulatory filings. The SRP provides critical oversight of the medical safety of patients in the clinical trial through frequent and detailed medical data reviews, adverse event and medical history codings, review and coding of protocol deviations, and frequent site interactions to ensure protocol compliance, data quality, and patient safety. Team matrix interactions of the SRP include project management, finance, legal, quality assurance & compliance, clinical supplies, regulatory affairs, data management, medical writing, biostatistics, global safety, global medical affairs, clinical operations, and other scientific and business-related disciplines. The SRP may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area.

ESSENTIAL FUNCTIONS:

• 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 research, in concert with senior clinical personnel, in preparation for health authority submissions

• Close interactions with Project Clinical Scientists and Physicians across programs

QUALIFICATIONS:

• MD (or equivalent) is required.

• Board Certification (or equivalent) in Neurology with experience in interpreting neurophysiologic studies (electromyography- EMG, nerve conduction studies - NCS, repetitive nerve studies - RNS) is strongly preferred. Strong experience in neurodegenerative disorders may be considered in place of experience in neurophysiology.

• Two or more years' experience in Pharma (clinical development, medical affairs or pharmacovigilance) is required. Experience with neurology trials in industry setting is preferred.

ADDITIONAL REQUIREMENTS:

• Exceptional interpersonal and communication skills, with the