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The focus of the Associate Director/Study Responsible Scientist (SRS) is to support various clinical research tasks associated with assigned Immunology Development clinical trials. 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.
- Tracking of safety events, review of new SAEs, and composing adverse event Narratives.
- Support preparation of the clinical content of drug safety documents and reports such as the investigator brochures, DSURs, and other regulatory response documents.
- Set up medical monitoring data review activities.
- Report the status of clinical trials to management.
- Member of the cross-functional clinical trial team for assigned studies.
- Participation in the development of clinical study documents ( e.g., protocols, informed consent documents, case report forms).
- Participate in the preparation and assure the accuracy of the clinical study report and any external publications.
- Interact with staff responsible for the design, set-up, execution, analysis and reporting of these studies.
- Performing clinical data review and assist in the preparation of clinical safety presentations and reports.
Activities which support the execution, monitoring, and reporting of clinical trials.
- Assist with managing other vendor activities such as laboratory, histology or imaging.
- In collaboration with GDO, identifying clinical sites and CROs that will participate in trials.
- Support activities related to the start-up and execution of new clinical trials.
- Review incoming data from the study for accuracy and completeness.
- Participate in the review and interpretation of clinical trial data to enable timely internal decision-making and external communication with investigators and regulatory agencies.
Qualification & Experience:
- BS, MS, PharmD, PhD or RN preferably with a scientific background in Immunology or a related field, and 6-10 years industry experience is required.
- Experience with Ph 2 and Ph 3 studies in immunology indications is preferred.
- Ability to survey and interpret the scientific literature related to the assigned projects is required.
- Strong organizational skills and the ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the business.
Company: Johnson & Johnson
Vacancy Type: Full Time
Job Location: Spring House, PA, US
Application Deadline: N/A