Study Responsible Physician- Neuroscience Late Development

Johnson & Johnson Innovative Medicine; Titusville (NJ); On-site; USD 199,000 - 344,000; Full time

Benefits offered by this job

Vacation time

Parental Leave

401(k) plan

Medical benefits

Job summary

Johnson & Johnson Innovative Medicine is recruiting for a Neuroscience Late Development Study Responsible Physician (SRP) to be based at Titusville, NJ or Spring House, PA. You will design and execute Ph 2/3 studies in the Neuroscience TA Late Development portfolio, providing medical and scientific leadership on development plans, trial protocols, and regulatory documentation.

You will oversee safety reviews, contribute to data interpretation for health authority submissions, and work closely

Qualifications

• MD (or MD/PhD) in relevant area; MD/PhD.
• Experience in neuroscience (psychiatry, neurology) highly preferred.
• Minimum 1 year conducting clinical trials in pharma/biotech/CRO or minimum 2 years in academia.
• Experience with Good Clinical Practices and regulatory requirements.

Responsibilities

• Medical monitoring/reporting and company safety officer activities.
• Develop clinical development plans and trial protocols; own clinical study reports.
• Evaluate adverse events for relation to treatment.
• Assist Regulatory Affairs on regulatory requirements and health authority reporting.
• Act as medical contact for health authorities when required.
• Lead interpretation and presentation of study results for stakeholders.
• Collaborate with cross-functional teams including project scientists and regulatory affairs.
• Contribute to development of drug regulatory strategies and data interpretation.
• Support exploration of new assets and review relevant literature.
• Participate in AdBoards and KOL interactions as needed.

Skills

Medical monitoring

Clinical trial oversight

Adverse event assessment

Regulatory liaison

Scientific communication

Education

MD (or MD/PhD) in Neuroscience

Experience in neuroscience (psychiatry/neurology)

Tools

Excel

Word

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 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 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 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

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 https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

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)).

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