Covance Sr. Medical Director/Medical Director - Pulmonary / Respiratory in Denver, Colorado
Reporting to the Executive Medical Director, the primary role of the Medical Director 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 will play a key role in client relations, business development representing the organization in proposals and industry meetings.
This is a remote home-based role supporting US trials.
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
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.
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
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.