Study Responsible Physician- Neuroscience Late Development

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

25d•Hybrid

About The Position

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

Requirements

MD (or equivalent) in relevant area
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

Nice To Haves

MD/PhD
Experience in neuroscience (psychiatry, neurology) highly preferred
Clinical Operations
Clinical Research and Regulations
Clinical Trials
Collaborating
Data Governance
Data Management and Informatics
Developing Others
Drug Discovery Development
Global Market
Inclusive Leadership
Industry Analysis
Innovation
Leadership
Market Research
Program Management
Research Ethics
Scientific Evaluation
Scientific Research
Stakeholder Management

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

Benefits

employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
This position is eligible to participate in the Company’s long-term incentive program
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