Clinical Development Scientist
Location:
, Massachusetts
Posted:
November 18, 2017
Reference:
R0015418
  • Responsible for providing scientific support for the company's clinical research and product development initiatives under the direction of GDTL
  • Assist in the preparation of clinical output summary reports, Power Point presentations of the clinical data, clinical trial synopses, patient profiles
  • Provides clinical scientist input into regulatory questions, runs ad hoc searches
  • Preparation of targeted reviews/profile of outliers, search and summarize information relevant for various clinical documents preparation
  • Assist the Medical Monitoring of trial data and development and review of clinical study documents, reports etc
  • Support GDTL to provide scientific leadership in execution of clinical trials
  • Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, data management, pharmacovigilance to ensure quality processes and deliverables
  • Serve as a resource to address medical questions or clarify issues during conduct of the study
  • Assist in the review, analysis and reporting of clinical trial data
  • Assist with ongoing monitoring of safety data and regular medical review of clinical trial data
  • Serve as a scientific resource to cross-functional internal teams to facilitate quality of study execution and problem resolution
Responsibilities
  • Collaborates with GDTL to ensure that all development and product support activities for the assigned projects are coordinated and consistent
  • Interacts as needed with partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams
  • Supports the GDTL when participating in marketing and clinical/medical advisory panels, steering committees and investigator meetings
  • Assist the GDTL in assuring the conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles
  • Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities
  • Supports the GDTL to provide expert scientific clinical development advice and leadership to the project teams for the development of Phase I-IV clinical programs
  • Assists in the development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy
  • Participates in drug safety surveillance for Development projects
  • Act on behalf of GDTL leading the interpretation of trial data and development and review of clinical study documents, reports etc
Education & Experience Requirements
  • Bachelor's degree in Scientific/healthcare field is required. Advanced degree preferred
  • Significant experience of clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization
  • Demonstrated ability to collaborate in a matrixed environment
  • Experience in submissions of IND/NDA and interactions with Regulatory authorities are a plus
  • Experience in designing and conducting clinical trials
  • Significant late-stage development research is a plus
Other Requirements
  • Availability to travel occasionally
  • Availability to participate in early or late meetings/teleconferences



A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.

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