Director, Study Responsible Physician - Milvexian (Neurology)

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Director, Study Responsible Physician - Milvexian to be located in Raritan, NJ .  Remote work options may be considered on a case-by-case basis and if approved by the Company.
 
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC. discovers and develops innovative medical solutions to address important unmet medical needs in the following therapeutic areas: immunology, oncology, neuroscience, infectious diseases & vaccines, cardiovascular & metabolism, and pulmonary hypertension. Please visit http://www.JanssenRnD.com for more information. 
 
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. We are guided by our Credo .
 
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Study Responsible Physician (SRP) is responsible for development and execution of medical and scientific strategy for a selected clinical trial(s) in the development program for Milvexian and operational implementation, delivered through the effective communication with Cross-Functional Trial Team (CFTT).  The SRP provide support to a Clinical Leader (CL) to deliver a trial(s) in a timely and cost-effective manner or program wide activities and is responsible for site interactions in partnership with the Study Responsible Scientist (SRS) for medical questions and education (including safety management guidelines), protocol development, execution, preparation and ownership of clinical study reports and for the preparation and approval of essential documents for regulatory filings. Performs medical safety data review, including evaluation of adverse events and eligibility of participants for assigned studies. May also be responsible for program wide activities such as interactions with IDMC, clinical events committee. May leads or co-leads CFTT, provides leadership via matrix interactions also includes individuals from project management, operations, regulatory affairs, data management, medical writing, biostatistics, benefit-risk management, pharmacogenomics, drug discovery, early clinical development, clinical pharmacology, clinical operations. The SRP is also expected to assist in the leadership of the evaluation of scientific opportunities in the therapeutic area.

ESSENTIAL FUNCTIONS:

• Supervision, and development of junior medical staff assuring diversity of candidates
• Supports development of clinical development plans and ownership for the design of clinical trials and for the content of clinical study reports
• Interprets, reports and prepares results of product research in preparation for world-wide health authorities and submissions
• Responsible for medical monitoring/reporting and safety officer activities; Evaluates adverse events (pre and post-marketing) for relationship to treatment
• Assists Regulatory Affairs in determining requirement for any corrective actions or health authority reporting
• May act as medical contact at company for worldwide health authorities concerning clinical/medical issues
• Assists Regulatory Affairs in the development of drug/device regulatory strategies
• May act as company spokesperson regarding publication of clinical research findings and presentations to relevant global health authorities and advisory committees
• Helps explore and evaluate new product ideas to assist in identifying new marketing opportunities
• Supports general activities involving product evaluation, labeling and surveillance
• May support early clinical development and discovery activities involving product potential and development for registration
• Participates on evaluation of new product ideas, implement franchise business strategies, etc.
• Responsible for assessment of medical publications emerging from the Team and its affiliates; Responsible, with appropriate colleagues, for review of Company advertising and promotion
• Ensures the study is executed within a budget for all project related clinical activities
• Maintain personal knowledge of assigned therapeutic indication(s)