Associate Director, Clinical Project Scientist (Oncology) - Spring House Pennsylvania

Company: Disability Solutions
Location: Spring House, Pennsylvania
Posted On: 04/21/2024

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Johnson & Johnson is recruiting for an Associate Director, Clinical Project Scientist, Oncology. The position can be located in Spring House, PA; Raritan, NJ; High Wycombe, UK; Beerse, Belgium; Breda, Netherlands. Remote work options within the United States, United Kingdom and European Union may be considered on a case-by-case basis and if approved by the company. As the Associate Director, Clinical Project Scientist, you are 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 clinical study reports and supports preparation of relevant documents for regulatory filings. The Clinical Scientist will collaborate with Study Responsible Physician(s) in monitoring of clinical trial conduct. This role involves extensive team matrix interactions with colleagues from a number of different disciplines. Primary Responsibilities Include:

• Supports medical monitoring and reporting, evaluates clinical trial adverse events, reviews clinical laboratory results
• Participates in preparation of clinical development plans, trial protocols and clinical study reports
• Interacts with clinical investigators
• Support Clinical Operations during trial set up, conduct, monitoring, and closeout 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
• Assists with drafting 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
• Assists Regulatory Affairs in the development of drug regulatory strategies
• Support general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance
• Reviews medical literature and related new technologies
• May be asked to assess/co-author medical publications emerging from the team and its affiliates More...

      

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