Radius Health, Inc.

Senior Director, Clinical Development

US-MA-Waltham
2 months ago
Job ID
2017-1610
# of Openings
1
Category
R&D Management

Overview

The Senior Director, Clinical Development, designs and implements clinical trials, including writing medical protocols, creatively working to assess appropriate endpoints and interfacing with Clinical Operations to implement trials. The incumbent would work closely with biometrics group and clinical operations to assure accuracy of clinical data and robustness of study outcomes.        

Responsibilities

  • Integrates relevant scientific findings from the project and the literature, to facilitate research and overcome scientific challenges.
  • Designs and implements clinical trials, including writing protocols, creatively working to assess appropriate endpoints and interfacing with Clinical Operations to implement trials.
  • Interprets data, assess integrity of data and provide scientific summaries.
  • Works closely with biometrics group and clinical operations to assure accuracy of clinical data and robustness of study outcomes.
  • Works closely with Project Head, CSO, Research, Clinical and other project team members to achieve the scientific goals.
  • Identifies CROs or other collaborations that further scientific objectives or apply expertise that is not available in-house.
  • Assists  in Life Cycle Management, regulatory submission activities, and indication development.
  • Collaborates with, monitor and report CRO based study results to the project team.

 

Qualifications

  • PhD or MD with at least 10 years’ clinical trial experience preferred; a Bachelors or Masters in a scientific discipline with at least 10 years’ directly relevant industry experience is required. 
  • Demonstrated expertise in the design, authoring and successful implementation of clinical protocols and clinical study reports.
  • Strong experience reviewing & interpreting study data/reports and presenting findings to project team members.
  • Excellent organizational, written and oral communications skills.
  • Demonstrated experience in scientific writing.
  • A deep understanding of oncology drug development and experience working in cross-functional teams is highly desirable.
  • Experience across the range of early and late stage clinical development is desirable.

 

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