Sr. Medical Director - Respiratory / Critical Care, Infectious Disease

    Miami, FL 33131
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    Job Description

    Job Overview:

    Reporting to the Executive Medical Director, the primary role of the incumbent will be to provide subject matter and drug development expertise in support of Respiratory/Pulmonary, Critical Care, and Infectious Disease drug development trials. He/She will be expected to be a key contributor to the medical strategy and execution of clinical programs.  Furthermore, the Medical Director or Sr. Medical Director will play a key role in client relations, business development representing Covance in proposals and industry meetings, and potentially people leadership/management as needed. 


    This is a remote home-based role supporting US trials.


    Client Relationship & Business Development Activities

    • Partnering with GCO to develop new and enhance existing client relationships where possible
    • Provides leadership and presents medical/scientific capabilities to clients as a participant of a proposal team
    • Leverage known and builds new relationships with investigators/sites to performs site/ investigator feasibility and to support optimal recruiting and conduct of trials
    • Able to present or serve on panels to represent the company at conferences and scientific meetings.


    Therapeutic and Scientific Expertise

    • Responsible for medical and safety monitoring on assigned projects
    • Develops training modules and materials, and provides training in disease states and protocol specific requirements
    • Participates in training opportunities to advance knowledge of drug development and good clinical practice guidelines
    • Serve as global lead project physician and provides clinical and medical expertise
    • May serve as a program level physician across multiple studies for a given company
    • Provides subject matter and drug development expertise to be a key contributor to the medical strategy and execution of the program for the client
    • Performs medical data review and/or oversight of central medical data review- laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed, holistic and aggregated data review
    • Develops, reviews and revises protocols, case report forms, training materials, project specific tools, analysis plans design, clinical trial reports and new drug applications
    • Prepares materials for investigator meetings
    • Actively participates in investigator meetings
    • Provides medical/scientific expertise to project teams and to other Covance departments
    • Interacts with inter-departmental and external consultants as appropriate
    • Participates in feasibility discussions relating to specific project proposals
    • Participates in project risk assessment activities
    • Assists when needed with data safety monitoring board activities
    • Contributes to the scientific strategic leadership for clinical programs.


    • MD degree
    • Fellowship trained in Pulmonary Disease and/or Critical Care
    • History of Board Certification in Pulmonary Disease and/or Critical Care is highly preferred
    • Excellent communication and interpersonal skills


    • 5+ years of medical monitoring experience in CRO or Pharma/Biotech 
    • Experience with Pulmonary/Respiratory trials; COPD, Asthma
    • Experience supporting Phase II- IV clinical trials
    • Previous experience in clinical patient care preferred
    Posting ID: 584170685Posted: 2020-12-02