Associate Director, Clinical Research

工作内容

Janssen Research and Development, L.L.C., a member of Johnson and Johnson’s Family of Companies, is recruiting for an AssociateDirector Clinical Research (Neuroscience)located preferably in Raritan, NJ, Titusville, NJ, or Belgium (Beerse).

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. We pursue the most promising science, wherever it might be found.

We discover and develop innovative medical solutions to address unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Visit to learn more.

• The Project Scientist is a responsible member of a clinical team dedicated to the development and execution of clinical trials and the clinical and operational implementation of a complex compound program.
• The Project Scientist provides active scientific contribution to a cross-functional clinical team developing a molecular entity. Specifically, the Project Scientist provides input to the clinical development plan, develops the clinical trial protocol and clinical trial materials, engages in ongoing monitoring of study conduct, review and analysis of clinical trial data, 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 a number of different disciplines.
• The position will also have responsibility for various activities associated with safety monitoring and assessment of relevant clinical studies/programs, and will have clinical ownership of or provide clinical support for various regulatory documents, including the Investigator Brochure, the Risk Template of the Informed Consent form, the Development Safety Update Report (DSUR), the Periodic Benefit Risk Evaluation Report (PBRER) and the Safety Risk Management Plan.
• The Project Scientist may be asked to contribute to due diligence efforts in the therapeutic area.
• Supports preparation of clinical development plans, trial protocols, and supports the Global Development group with trial set up, conduct, and monitoring, and database locks.
• Support the assessment and review of clinical safety data from studies by collecting and summarizing appropriate safety data/information including evaluation of adverse events for review by the Clinical Leader, Medical Leader, and/or Study Responsible Physicians (SRPs) or Safety Management Team (SMT).
• Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting
• Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for internal reviews and health authority submissions
• Responsible for data review in conjunction with other clinical team members prior to database locks
• May be asked to participate in safety event adjudication efforts
• Participate in cross-Pharma and Neuroscience TA initiatives as requested
• Participate on and may lead cross-functional teams for evaluation of new product ideas
• Reviews medical literature and related new technologies

Qualifications

• A minimum of a Bachelor’s degree is required.
• An advanced degree is strongly preferred.
• A minimum of 5 years of experience working in clinical trials is required.
• Experience in Neurology, Psychiatry or Neuroscience is preferred.
• Clinical research operational knowledge, strong project planning/management and excellent communication skills is required
• Ability to operate with limited day to day supervision is required
• Independent decision-making and analytical skills are required.
• Successful work experience in a matrix team environment with cross functional teams is required.
• Travel up to 20% of time both domestic and international is required.

Primary Location

United States-New Jersey-Titusville-1125 Trenton Harbourton Road

Other Locations

United States-New Jersey-Raritan, United States-Pennsylvania-Spring House, Belgium-Antwerp-Beerse

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2105920961W