Director, Medical Affairs

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As TMI’s clinical voice, provide clinical and technical support to maximize exposure within the health care community and to assist with local and international clinical strategies that support TMI’s new and existing products. Overall responsibility for the implementation of clinical communication plans, medical meetings, educational programs, and clinical trials.

RESPONSIBILITIES INCLUDE:

CLINICAL TRIALS MANAGEMENT
  • Develop, recommend, and lead clinical development initiatives and research that generates evidence to support TMI’s sales and marketing activities and product development objectives
  • Plan and track study timelines, deliverables and budgets to ensure that all key study targets are met
  • Review and assess clinical trial protocols as required
  • Assist with developing clinical presentations to address TMI’s needs
  • Advance other projects to support clinical research functions
MEDICAL MARKETING
  • Develop and deliver train-the-trainer training to Marketing and Sales staff members for application with distributors
  • Support reimbursement initiatives
  • Support the development and execution of medical marketing strategies by assisting as requested to:
    • Identify product opportunities that exploit TMI’s NPD core capabilities
    • Identify plans to combat competitive activity in the field
    • Develop marketing launch plans
  • Complete medical reviews and approvals for all sales, marketing and CME material and communication
    • Ensure compliance with applicable regulations or guidelines, i.e. as established by organizations such as PAAB, Health Canada, and FDA
  • Assist with market research requirements that aid in product development efforts
  • Participate as an active member of product development initiatives to ensure that customer focused objectives are achieved
TECHNICAL, PRODUCT AND INDUSTRY EXPERTISE
  • Interpret and provide analyses to Senior Management on published papers, studies, journal articles, etc. for the purpose of understanding developing trends in the industry and with TMI’s competition
  • Ensure that clinical related questions from sales business areas, distributors and consumers are adequately answered
  • Demonstrate in depth expertise (understanding and application) of key product performance requirements for TMI’s devices
  • Assist with protocol writing, report writing and coordination of publications
  • Assist with regulatory submissions
RELATIONSHIP MANAGEMENT
  • Secure global work opportunities through interactions with international stakeholders
  • Develop and maintain relationships with regulatory authorities
  • Develop relationships with key opinion leaders, industry associations and clinical stakeholders
  • Represent TMI at trade shows, congresses and related events as required
  • Provide support to TMI staff in New Product Development, Sales and Marketing, Regulatory Affairs, and Aerosol Science, and to external contacts as required, e.g. customers, regulatory bodies, etc.
HEALTH AND SAFETY AND POLICY COMPLIANCE
  • Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.
  • Adhere to all relevant policies, procedures and legislation
  • Lead the clinical function in accordance with Company goals, policies and procedures
SUPPLEMENTARY
  • Perform special projects as required
  • Participate in ongoing training and professional associations as appropriate
  • Fully utilize TMI resources to ensure delivery of a quality product to all internal and external customers at a minimal cost
  • Manage Medical Affairs’ operating plan, budget, monthly reports, procedures, and equipment maintenance to ensure efficient and consistent support to the organization

QUALIFICATIONS:
  • Medical Doctor
  • At least 5 years experience managing clinical trials
  • Clinical study associate, study team leader or continuing health education manager experience within the pharmaceutical or medical device industry is an asset
  • Recognized expertise in aerosol drug delivery gathered via clinical or industry experience
  • Established international network of key opinion leaders (KOLs) in the respiratory field preferred
  • Knowledge of Good Clinical Practices
  • Past published papers would be an asset
  • Exceptional oral communication skills with ability to deliver presentations to large audiences
  • Exceptional written communication skills
  • Good interpersonal skills with the ability to work independently and as part of a team
  • Understanding of medical devices regulatory issues
  • Willingness and ability to travel internationally
  • Demonstrated ability to establish and maintain effective interpersonal relationships
  • Ability to operate with diplomacy and tact
  • Experience with US, European and Asian markets
  • Demonstrated ability to make good judgments
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