Study Responsible Physician- Neuroscience (Pediatric Studies)

Study Responsible Physician- Neuroscience (Pediatric Studies)

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.

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 research, in concert with senior clinical personnel, in preparation for health authority submissions
• Close interactions with Project Clinical Scientists and Physicians across programs
• Assists Regulatory Affairs in the Pediatric development regulatory strategy
• Executes medical-related consultation for internal stakeholders to ensure unbiased data interpretation
• May help explore and evaluate new assets (BD) and/or products to support compound value, including review of medical literature related new technologies
• Participates in AdBoards & KOL interactions where required (together with / under supervisor of senior clinical personnel)
• Participates in the development of presentations and publications of study results

EDUCATION AND EXPERIENCE:

• MD (or equivalent) in relevant area; MD/PhD.
• Training or experience in neuroscience (e.g., child & adolescent psychiatry, neurology, neurodevelopmental disorders) and pediatric drug development is strongly preferred.
• 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, with the ability to interpret and leverage data for decision making.
• Strong communication and presentation skills to effectively convey complex ideas and strategic insights to stakeholders.
• Independent decision making and analytical skills are required.
• Ability to navigate complex relationships and resolve conflicts effectively
• Exceptional interpersonal and communication skills, with the ability to build strong relationships and influence without reporting authority.
• Excellent problem-solving and conflict resolution skills, with the ability to navigate complex and challenging situations.
• Proven experience and expertise in leading and managing in a matrix organizational structure.
• Exceptional problem-solving skills with the capacity to anticipate risks, to develop creative solutions and to meet objectives.
• Demonstrated ability to develop deep insights (e.g., big picture thinking) based on data analysis and interpretation.
• Results oriented, able to think creatively, critically, and proactively, to drive innovative solutions.
• Working knowledge of the use of Microsoft suite of software products including Excel and Word
• Fluent in written and spoken English