*NEW* SR. / EXEC. MEDICAL DIRECTOR

Are you open to an exciting clinical leadership opportunity with a well-financed biotech company led by a successful, nimble decision–making team? Our east-coast client is moving into a two year Phase III trial with a  much needed therapeutic to dramatically improve patients’ quality of life. If you have Phase III trial experience and want to be a leader in the NDA submission and approval of an important therapy for chronically suffering patients, here’s your chance. There is no better time to join this very promising clinical-stage biotechnology company where you would take an important new Breakthrough Therapy drug to approval and market. Additional early phase studies are also being initiated.

RESPONSIBILITIES

  • Provide medical input into the design of clinical trials
  • NDA preparation including prep/review of integrated summaries of safety and efficacy
  • Provide clinical leadership in preparation for and interactions with Regulatory Authorities
  • Be lead medical expert in establishing additional and novel therapeutic indications for lead compound
  • Present at investigator meetings, site visits, scientific/clinical meetings
  • Serve as medical monitor for clinical studies
  • Work closely with pharmacovigilance and safety representatives providing medical input into safety reports and communicate with CRO/investigators regarding follow-up
  • Cultivate and nurture collaborations with Investigators, academic partners, and KOL’s

REQUIREMENTS

  • MD with 7-10+ years of pharmaceutical/biotech-industry experience in a medical monitoring/leading role
  • Phase III experience
  • Relevant experience and understanding of strategic and operational aspects of clinical research and product development
  • Current US work authorization or TN-1 eligibility

PLUS FACTORS

  • NDA experience is a plus
  • Nephrology experience a plus
  • Dermatology experience a plus

To apply for this position, confidentially email us here.