Associate Director Clinical Scientist - Immunology Pediatric Development

Position Overview:

The focus of the Associate Director Clinical Scientist is to support various clinical research tasks associated with assigned Immunology Pediatric Development clinical trials, providing leadership in program execution, innovation, and optimization of execution. Scope of work will include tasks associated with the execution, monitoring, and reporting results of clinical trials evaluating therapeutics in immunologic disorders in pediatric populations. The range of tasks may vary to some degree depending on the therapeutic area and trial-specific requirements.

The Associate Director Clinical Scientist is a key member of pediatric development clinical trial teams and leads the team designing and execution of pediatric clinical studies in partnership with Study Responsible Physician/ Study Responsible Scientist. The Associate Director Clinical Scientist provides active scientific contribution to a cross-functional clinical team developing a molecular entity. The Associate Director Clinical Scientist provides input to the pediatric 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 different disciplines.

Responsibilities include:

• Performs activities which support the design, execution, monitoring, and reporting of clinical trials.

• Leads preparation of pediatric clinical development plans, trial protocols, case report forms, study operational plans

• Performs medical monitoring and reporting in partnership with Study Responsible Physician/Study Responsible Scientist, evaluates clinical trial adverse events, reviews clinical laboratory results, drafts adverse event narratives.

• Builds credible relationships with clinical investigators, medical/scientific experts

• Partners with Clinical Operations in trial set up, conduct, recruitment activities, closeout, and reporting

• 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

• Drafts and coordinates completion of clinical study reports

• Drafts 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

• Reviews medical literature and related new technologies