Medical Director - Clinical Research and Development

Company: Caratherapeutics
Location: Stamford
Posted on: April 8, 2021

Job Description:

Medical Director - Clinical Research and Development Key Responsibilities:

• Provide medical input into the design of clinical trials
• Serve as medical monitor for clinical studies (provide medical oversight of the study, answer questions about patient eligibility, review protocol deviations, review safety and adverse event information, MedDRA/WHO drug coding and any general medical-related study issues during the conduct of a trial)
• Work closely with cross functional study team, including external partners to ensure proper execution of ongoing clinical studies and initiation of new clinical trials to meet key milestones
• Work closely with pharmacovigilance and safety representatives providing medical input into safety reports, provide medical queries for SAEs and AEs and communicate with CRO/investigators regarding follow-up
• Assist in preparation/review of clinical protocols, CRF, medical monitoring and safety management plans, informed consent, IB, DSUR, TLFs, CSRs and any other relevant clinical documents
• Participate in preparation of clinical sections in support of IND, briefing book and NDA
• Present at investigator meetings, site visits, scientific/clinical meetings as applicable Requirements:
  • MD with a minimum of 5 years of pharmaceutical/biotech-industry experience in a medical monitoring (Phase II-III)
  • Experience in the therapeutic area (nephrology) would be desirable
  • Relevant experience and understanding of strategic and operational aspects of clinical research and product development a must
  • Excellent clinical and scientific judgment, organizational skills and strong leadership ability in communication and networking
  • Strategic thinking and ability to work with collaborators
  • Ability to produce written scientific/medical communications with clarity, accuracy and scientific rigor
  • Demonstrated ability to communicate effectively through formal presentation and through informal scientific/medical discussion with credibility, accuracy, and confidence; demonstrated experience and ability to relate to both internal and external stakeholders

Keywords: Caratherapeutics, Stamford , Medical Director - Clinical Research and Development, Healthcare , Stamford, Connecticut