Medical Director/Sr Medical Director - MD (Respiratory)

LabCrop
Management
More than 9 years
Other
24 Mar 2022

Job Overview:


Medical Director, Respiratory

The group plays a pivotal role in the drug development process through strategic consulting, medical monitoring and clinical trial development.

This senior position will bring a track record of success in previous roles and be able to demonstrate strong leadership, therapeutic and business acumen. The person will drive new initiatives and ideas and also be highly agile in order to adopt and bring to live the new ideas and innovations to enhancing business, culture and processes.

Therapeutic and Scientific Expertise

  • Develops training modules and materials, and provides training in disease states and protocol specific requirements across the Company
  • Participates in training opportunities to advance knowledge of drug development and good clinical practice guidelines
  • Serves as global lead project physician
  • Performs medical data review - Reviews laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed
  • 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
  • Responsible for medical and safety monitoring on assigned projects
  • 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

Company Focus

  • Contributes to the development of Company policies involving medical, safety and therapeutics
  • Participates in process improvement activities across Company
  • Performs other duties as assigned


Client Relationship & Business Development Activities
  • Partnering with GCO to develop new and enhance existing client relationships where possible
  • Presents medical/scientific capabilities to clients as a participant of a proposal team
  • Performs site/investigator feasibility, builds relationships with investigators to support optimal recruiting and conduct of trials


Managerial
  • Supports and participates in the recruitment process for department positions


Leadership
  • Provides leadership to junior staff within the therapeutic area
  • Participates and leads initiatives that serves the physicians within the TA


Therapeutic and Scientific Expertise

  • Develops training modules and materials, and provides training in disease states and protocol specific requirements across the Company
  • Participates in training opportunities to advance knowledge of drug development and good clinical practice guidelines
  • Serves as global lead project physician
  • Performs medical data review - Reviews laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed
  • 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
  • Responsible for medical and safety monitoring on assigned projects
  • 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
  • Provides clinical and medical expertise to other Covance departments

Anywhere in EMEA

Education/Qualifications:

Medical Degree. Board certification in Internal Medicine/ General Medicine or Pulmonary.

Experience:

Significant experience in Respiratory diseases, as a clinician and in the pharmaceutical/ CRO business.
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