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This position will serve as Senior Director for Clinical Immunology for marketed and investigational products in development, with indications in Gastroenterology. The Sr. Director will be responsible for oversight of clinical development programs, including design, execution, and reporting of Phase 2 and 3 clinical trials. He/she will provide the highest-level of scientific expertise through entire clinical trial process including interactions with commercial and all level of management.Responsibilities for the Senior Director include overall program leadership:Designing of Clinical development program (CDP), as well as execution and reporting of trials
Monitoring safety of clinical trials and providing scientific leadership in the area of responsibility
Providing scientific & clinical leadership of Phase 2 and 3 clinical trial teams
Leading the development of the Integrated Study Plans and study summaries, IND submissions, and technical reports
Providing input to strategic decisions regarding therapeutic indications
Overseeing the preparation of clinical portions of Immunology project INDs, IBs, CTAs, BLAs and other regulatory submissions
Authorship of abstracts and manuscripts for publication based on clinical trial data
Presenting data and scientific information to the organization at all levels
Building credible relationships with opinion leaders and external alliances for partnered products when relevant
Line management accountability for promotions, recruitment strategy and team structure
May evaluate in-licensing opportunities and contribute to early development programs
QualificationsMD is required
Board certification in a relevant therapeutic area is desired
Experience in Gastroenterology clinical development desired.
A minimum of 5 years of clinical research or clinical trials experience preferably in an industry setting is strongly preferred
Must have strong planning and communication skills to manage and proactively identify resource issues
Experience in clinical trial design and medical monitoring is highly desired.
Prior experience in a leadership role is a must.
This position may require up to 10% annual travel (domestic and international).
ImpactImmImmDevelopmentPrimary LocationUnited States-Pennsylvania-Spring House-Other LocationsUnited States-Massachusetts-Boston, United States-California-La JollaOrganizationJanssen Research & Development, LLC (6084)Job FunctionR&DRequisition ID2005864352W
