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The Early Development (ED) Project Physician Psychosis Spectrum Illness is a responsible member of a clinical team dedicated to the clinical implementation of compounds’ early phase/translational medicine strategy, including. study design, patient selection and precision approaches, endpoints (including novel endpoints), safety evaluation, dose, pharmacology, and pharmacodynamic biomarkers. This may include Phase 0 and experimental medicine studies as well as Phase 1 through Phase 2b studies. The ED Project Physician provides active medical and scientific contribution to a cross-functional discovery, biomarkers and clinical teams, including development and execution of the precision medicine and biomarkers strategy. The ED Project Physician provides input to translational discovery and the clinical development plans, works on the development of the clinical trial protocol, clinical trial materials, oversees and monitors clinical trial execution (including patient safety and data quality) and takes ownership for the content of clinical study reports and relevant documents for regulatory filings. Team matrix interactions include discovery, biomarkers, data science, clinical operations, project management, quality monitoring & compliance, data management, global medical safety, biostatistics, regulatory affairs, clinical supplies unit, medical writing, clinical pharmacology, legal, finance, quality assurance, strategy and operations, global medical affairs, health economics, epidemiology and other scientific and business-related disciplines. The ED Project Physician may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area

ESSENTIAL FUNCTIONS:

• Responsible for the development and execution of the ED clinical trial protocol(s); ensures quality implementation of study in collaboration with the cross-functional clinical team and CRO/Contractors as needed

• Works closely with discovery, biomarkers, data science and translation teams to align preclinical and clinical biomarker strategies, including the identification and validation of novel endpoints (e.g., biomarkers, intermediate clinical endpoints, digital COAs) to support patient stratification and rapid decision making.

• Close collaboration with Clinical Scientists, Clinical Operations, Medical Monitors, Statistics, Data Management, Biomarkers, Data Science and other functional leaders to ensure data integrity and high-quality trial execution

• Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions

• Primary responsible party for Medical Monitoring, including e valuation of adverse events for relationship to treatment

• Responsible for developing and presenting content for Independent Data Monitoring Committee (IDMC) and adjudication meetings as needed

• Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting

• May act as a medical contact at the company for health authorities concerning clinical/medical issues

OTHER RESPONSIBILITIES / DETAILED DUTIES:

• 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

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

Qualifications

Education:

MD (or equivalent) in relevant area with appropriate post-doctoral training and certification; MD/PhD with background in neuroscience highly preferred.

Required Technical Knowledge and Skills: Experience/ expertise in in experimental medicine-based early human studies that confirm mechanism of action, pharmacology and initial assessments of efficacy or biomarker enabled/guided drug development desirable

Fluent in written and spoken English

• 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

Special Training or Certification: MD or international equivalent; a specialist qualification in psychosis spectrum illnesses or relevant clinical / research experience in this field is highly desired; preference given to those with translational or experimental medicine research experience

Experience Required: Minimum of 1-3 years conducting clinical trials in pharma/biotech/CRO or minimum of 2 years conducting clinical trials in academia

The anticipated base pay range for this position is $187,000 to $334,650 USD.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long term incentives, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com.