Study Responsible Physician- Neuroscience (Pediatric Studies)

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Johnson & Johnson is recruiting for a Study Responsible Physician- Neuroscience (Pediatric Studies) to be based in Beerse Belgium.

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 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.

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

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

• Belgium- Requisition Number: R-066431

• Switzerland- Requisition Number: R-066780

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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