Sr. Medical Director / Medical Director - Respiratory / Pulmonary

Company: Covance
Location: Raleigh
Posted on: January 15, 2021

Job Description:

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 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. Education/Qualifications: MD degree Fellowship trained in Pulmonary and/or Respiratory Disease History of Board Certification in Pulmonary and/or Respiratory Disease is highly preferred Excellent communication and interpersonal skills Experience: 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

Keywords: Covance, Raleigh , Sr. Medical Director / Medical Director - Respiratory / Pulmonary, Executive , Raleigh, North Carolina