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
Neuroscience Late Development Study Responsible Physician (SRP) to be based at one of our sites in Titusville, NJ or Spring House, PA.
The 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
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):
- United States- Requisition Number: R-066453
- Belgium- Requisition Number: R-092495
- Switzerland- Requisition Number: R-083629
#LI-Hybrid
Required Skills:Preferred Skills:The anticipated base pay range for this position is :$199,000.00 - $343,850.00
Additional Description for Pay Transparency:
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)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
• 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 period10 days
• Volunteer Leave - 32 hours per calendar year
• Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
