Medical Director, Early Development, Cardio-metabolic

Medical Director, Early Development, Cardio-metabolic

September 27th, 2019 by

The Early Development Leader (EDL) will be responsible for providing scientific/ medical direction and leadership for pre-clinical/ early clinical programs for biotech’s Early Development cardiovascular-metabolic pipeline. The Medical Director will lead the early phase clinical development of compounds in the cardiovascular-metabolic therapeutic area from first-in-man studies through proof of concept and translational projects as part of the initial drug development strategy.

The Medical Director will be responsible for representing Early Development during interactions with other functions and key external stakeholders including regulatory agencies and the scientific community.

The EDL will be responsible for enhancing the scientific capabilities in the cardiovascular-metabolic therapeutic area including but not limited to:

  • Serve as an internal clinical expert for translational and clinical programs in the cardiovascular-metabolic therapeutic area
  • Serve as medical monitor for clinical trials and assists in resolving major issues that may affect the studies
  • Present information internally and externally, anticipating and proactively managing problems across a broad spectrum of cross-functional teams
  • Provide guidance and assistance in the identification and management of phase 1 collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects
  • Ensure appropriate training, recruitment, and development requirements for matrix team resources
  • Will be the primary Early Development contact for basic scientists in discovery research as well as for clinical research scientists overseeing later clinical development
  • Evaluate external opportunities for partnering or licensing new cardiovascular-metabolic assets

Basic Qualifications 

MD/DO degree from an accredited medical school

AND

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

Preferred Qualifications 

  • Subspecialty board eligibility/certification in Internal Medicine, Gastroenterology, Cardiology or Endocrinology
  • Strong basic science or clinical research background in academia or industry
  • Prior experience authoring, monitoring, analyzing, and presenting clinical trial data
  • A record of high quality peer-reviewed publications
  • Previous experience in early phase development and/or biomarker work
  • Previous experience in late stage clinical trials and regulatory filings
  • Demonstrated expertise in conducting translational and/or clinical research
  • Expertise in Spotfire or other data analysis tools
  • Knowledge of GCP, EMA, and FDA policies
  • Expertise in authoring clinical sections of CTA or INDs
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