Radius Health, Inc.

Director / Sr. Director, Clinical Lead Tymlos

US-MA-Waltham
4 weeks ago
Job ID
2017-1630
# of Openings
1
Category
Clinical Development

Overview

The Clinical Lead for Tymlos will have responsibility for the development, execution and reporting of phase 3 and phase 4 clinical trials and will provide support for life cycle activities.  The ideal candidate will have clinical development experience and familiarity with the field of osteoporosis.  The candidate should have excellent organizational and communication skills and the ability to prioritize and handle multiple tasks effectively in a rapidly growing company environment.

Responsibilities

  • Drive clinical activities for Tymlos
  • Integrates relevant scientific findings from the project and the literature, to facilitate research and overcome scientific challenges.
  • Design and implement clinical trials including writing medical protocols and other study-related documents, creatively working to assess appropriate endpoints
  • Interprets data, assess integrity of data and provides scientific summaries.
  • Support regulatory documentation and submissions for the clinical program
  • Works closely with biostatistics to complete statistical analysis plan.
  • Works with team members in Clinical Operations, Research, Medical Writing, Medical Affairs, Program Management, CMC and Regulatory Affairs to deliver drive completion of clinical activities on time and within budget
  • Identify CROs or other collaborations that enable models or apply expertise that is not available in-house.
  • Provide support for Life Cycle Management of Tymlos, clinical submission activities, and indication development.
  • Collaborate with, monitor and report CRO based study results to the project team.
  • Support and contribute to the development of overall program clinical development plan.
  • Participate in Clinical Advisory Meetings and Investigator Meetings.

Qualifications

  • PhD or MD with at least 10+ years’ clinical trial experience preferred.
  • 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 therapies in the osteoporosis setting is highly desirable.
  • Oversee design, execution and analysis of Phase I-IV studies.

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