Study Responsible Physician- Neuroscience (Pediatric Studies)

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

4d•Hybrid

About The Position

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.

Requirements

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

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

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is 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
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year