Medical Director, Project Physician, Clinical Development - Neuroscience/Alzheimer's

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. Learn more at https://www.jnj.com

Job Function

Discovery & Pre-Clinical/Clinical Development

Job Sub Function

Clinical Development & Research – MD

Job Category

People Leader

All Job Posting Locations:

Cambridge, Massachusetts, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description

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

Position Summary

The Project Physician is a responsible member of a clinical team dedicated to the development and execution of medical strategies and the clinical and operational implementation of a complex compound program. The Project Physician provides active medical and scientific contribution to a cross-functional clinical team. The Project Physician provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and takes ownership for the content of clinical study reports and relevant documents for regulatory filings. Team matrix interactions include project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs, data management, medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations, health economics, epidemiology and other scientific and business related disciplines. The Project Physician may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area.

Essential Functions

• 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
• 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 Scientists and Physicians across programs
  
  

Other Responsibilities / Detailed Duties

• Assists Regulatory Affairs in the development of drug regulatory strategies
• Helps explore and evaluate new product ideas to assist in identifying new market opportunities
• Support general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance
• Participate on and may lead cross-functional teams for evaluation of new product ideas, implement franchise business strategies, etc.
• Reviews medical literature and related new technologies
• May be asked to assess medical publications emerging from the Team and its affiliates
• May be responsible, with appropriate colleagues, for review of Company advertising and promotional materials.
  
  

Education

MD (or equivalent) in relevant area with appropriate post-doctoral training and certification

Required Technical Knowledge And Skills

• Fluent in written and spoken English
• Working knowledge of the use of Microsoft suite of software products including Excel and Word
• Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
• Exceptional analytical and critical thinking skills, with the ability to translate complex data (scientific/financial/operational) into actionable insights for strategic decision making.
• Exceptional communication and presentation skills, with the ability to clearly articulate complex ideas to cross functional teams and stakeholders