Study Responsible Physician- Neuroscience Late Development

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Johnson & Johnson is recruiting for a Neuroscience Late Development Study Responsible Physician (SRP) 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 worlds toughest brain health challenges including multiple sclerosis Alzheimers disease Parkinsons 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 Neuroscience Late Development Study Responsible Physician (SRP) is responsible for design and execution of Ph 2/3 studies in the Neuroscience TA Late Development portfolio. 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

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 development of drug regulatory strategies

• 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.

• Experience in neuroscience (psychiatry neurology) highly preferred.

• Minimum of 1 year conducting clinical trials in pharma/biotech/CRO or minimum of 2 years conducting clinical trials in academia.

• 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

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

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