Associate Director, Clinical Scientist - Immunology

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for an Associate Director, Clinical Development, Immunology, to be located in Cambridge, MA, Spring House, PA, or San Diego, CA.
 
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.  https://www.jnj.com/credo/
 
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion.  Proud to be an equal opportunity employer.
 

Position Overview:

The focus of the Associate Director Clinical Scientist is to support various clinical research tasks associated with assigned Immunology Development clinical trials, providing leadership in program execution, innovation, and optimization of execution. Scope of work will include tasks associated with the execution, monitoring, and reporting results of clinical trials evaluating therapeutics in immunologic disorders. The range of tasks may vary to some degree depending on the therapeutic area and trial-specific requirements.

The Associate Director Clinical Scientist is a key member of development clinical trial teams and leads the team designing and execution of clinical studies in partnership with Project Physician(s).  The Associate Director Clinical Scientist provides active scientific contribution to a cross-functional clinical team developing a molecular entity. The Associate Director Clinical Scientist provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and takes responsibility for coordinating completion of clinical study reports and supports preparation of relevant documents for regulatory filings.  This role involves extensive team matrix interactions with colleagues from different disciplines.

 
Responsibilities include:

• Performs activities which support the design, execution, monitoring, and reporting of clinical trials.
• Leads preparation of clinical development plans, trial protocols, case report forms, study operational plans
• Performs medical monitoring and reporting in partnership with Study Responsible Physician, evaluates clinical trial adverse events, reviews clinical laboratory results, drafts adverse event narratives.
• Builds credible relationships with clinical investigators, medical/scientific experts
• Partners with Clinical Operations in trial set up, conduct, recruitment activities, closeout, and reporting
• Assists Data Management with the review of clinical data and query resolution
• Works closely with Quality Management & Assurance to ensure flawless execution of clinical trials
• Drafts and coordinates completion of clinical study reports
• Drafts responses to questions from Ethics Committees and Health Authorities
• Supports integrated document development for marketing authorization filing
• Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions
• Supports preparation for the FDA Advisory Committee and EU Oral Explanation
• Reviews medical literature and related new technologies