Associate Director, Clinical Project Scientist (1 of 3)

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Clinical Project Scientist located in Raritan, NJ.

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 oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension.  Please visit http://www.janssenrnd.com for more information.

The Associate Director, Clinical Project Scientist will be a responsible member of a clinical team dedicated to the development and execution of clinical strategies and the clinical and operational implementation of a complex compound program.  This individual will provide active scientific contribution to a cross-functional clinical team developing a molecular entity.  Provide input to the clinical development plan, work on the development of the clinical trial protocol, clinical trial materials, and take responsibility for coordinating completion of clinical study reports and support preparation of relevant documents for regulatory filings.  This role will involve extensive team matrix interactions with colleagues from a number of different disciplines.  This individual may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area.

Principal Responsibilities:

• Support preparation of clinical development plans, trial protocols, and support the operations group with trial set up and monitoring and assist with completion of clinical study reports.
• Assist Physicians in the evaluation of adverse events (pre and post-marketing) for relationship to treatment and support the interpretation and reporting of results.
• Assist Regulatory Affairs in determining requirements for any corrective actions or Health Authority (HA) reporting.
• Interpret, report and prepare oral and written results of product research, in concert with senior clinical personnel, in preparation for HA submissions.
• Perform data review in conjunction with other clinical team members.
• Assist Regulatory Affairs in the development of drug regulatory strategies.
• Participate on and may lead cross-functional teams for evaluation of new product ideas, implementing franchise business strategies, etc.
• Review medical literature and related new technologies.
• May be asked to lead the execution of contracts.
• May be asked to assess medical publications emerging from the team and its affiliates.
• May be responsible, with appropriate colleagues, for the review of company advertising and promotion.