Medical Director, Clinical Research, Cardiology – Biotech

Medical Director, Clinical Research, Cardiology

Medical Director, Clinical Research, Cardiology

September 27th, 2019 by

The Medical Director will join the global heart failure clinical development program, which includes approved and multiple investigational therapies across all phases of development.

Responsibilities

  • Provide clinical and scientific leadership and oversight for generation of scientific evidence, especially the development and execution of clinical trials across all phases of development
  • Interpret clinical trial data to author clinical study reports, publications and regulatory documents
  • Develop relationships and collaborate with academic partners and other key opinion leaders
  • Give scientific presentations at advisory boards, key scientific meetings and external committee meetings
  • Give clinical and scientific guidance and direction to:
    • Interactions with regulatory agencies
    • Global medical scientific platform and other scientific communications
    • Safety assessments
    • Clinical observational research projects
    • Health economics research and value and access strategy
    • In-licensing and out-licensing activities and partner relationships

Basic Qualifications

MD or DO degree from an accredited medical school

AND

2 or more years of clinical research experience and/or basic science research

Preferred Qualifications 

  • Accredited fellowship in Cardiology, board certified or equivalent
  • 5+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
  • Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO)
  • Knowledge of Good Clinical Practice (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
  • Demonstrated ability as a medical expert in a complex matrix environment

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