Study Responsible Physician- Neuroscience (Pediatric Studies)

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

1d•$199,000 - $343,850•Hybrid

About The Position

Johnson & Johnson is recruiting for a Study Responsible Physician- Neuroscience (Pediatric Studies) to be based at one of their sites in Titusville, NJ or Spring House, PA. This role is within the Innovative Medicine Neuroscience team, which focuses on tackling brain health challenges such as multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, epilepsy, schizophrenia, and autism, with a commitment to patient-focused advancements. The Neuroscience Therapeutic Area (TA) Study Responsible Physician (SRP) is responsible 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, collaborating closely with the Clinical Lead to provide expert pediatric medical and scientific leadership across all phases of study delivery. Key responsibilities include contributing to the clinical development plan with a focus on pediatric strategy, developing clinical trial protocols and materials, and supporting regulatory submissions. A central aspect of the role is the medical oversight of patient safety, involving in-depth review of clinical data, adverse events, medical histories, and protocol deviations. The SRP will frequently interact with sites to ensure protocol compliance, data quality, and the protection of pediatric trial participants, while offering medical guidance on safety or feasibility issues. The position operates in a highly matrixed environment, requiring collaboration with various departments such as project management, regulatory affairs, clinical operations, data management, biostatistics, global safety, and legal. The SRP may also evaluate scientific and clinical development opportunities within the Neuroscience TA.

Requirements

MD (or equivalent) in relevant area
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

Nice To Haves

MD/PhD.
Training or experience in neuroscience (e.g., child & adolescent psychiatry, neurology, neurodevelopmental disorders) and pediatric drug development is strongly preferred

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

Benefits

Eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
Eligible to participate in the Company’s long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year