Global Public Health (GPH) R&D Clinical Scientist - Data Management Director at Johnson & Johnson

Requisition ID: 2105927082W
Category: R&D
Organization: Janssen Pharmaceutica N.V. (7555)

 Job Description

• The Clinical Scientist is 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.
• The Clinical Scientist provides active scientific contribution to a cross-functional clinical team developing a molecular entity.
• The 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 a number of different disciplines.
• The Clinical Scientist may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area.

Essential Functions

• Participates in preparation of clinical development plans, trial protocols, has direct responsibility for trial set up and monitoring and takes responsibility for completion of clinical study reports
• Assists Physicians in evaluation of adverse events (pre and post-marketing) for relationship to treatment.  Safety assessments are the responsibility of the project physicians (PP)
• 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 health authority submissions
• Close interactions with Project Physicians and Physicians across programs
• 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.

Qualifications
For this Director function we are looking for:

• Master or PhD with 15-plus years of experience in drug development with strong data management expertise. This position will provide cross program advise to the GPH Clinical Scientists in the Capacity Development Group, on data management risks and challenges in low- and middle-income countries.
• Experience with vaccine programs is an asset.
• Living in a Sub-Saharan African country or Belgium is an asset.