Medical Affairs

  • location: Malvern, PA
  • type: Permanent
  • salary: $250,000 per year

job description

Medical Affairs

Job Title: Medical Director


Position Overview:

The Medical Director, Office of Medical Affairs, will provide scientific and medical support for the current and future product portfolio. This person will build strong partnerships with the internal organization and an outside medical community to maximize clinical value proposition.

We are looking for a highly motivated, organized and efficient person who is passionate to make a difference in the lives of people with psychiatric disorders. This person is a solid leader and a mentor to the organization.

Essential Duties/Responsibilities:

  • Work collaboratively with cross-functional teams, both internal and external, to define strategic medical objectives for business and generate global customer requirements.
  • Serve as the company's "point person" with the psychiatric community, developing relationships with thought leaders and clinical investigators and communicate their ideas and suggestions to the internal organization.
  • Contribute regularly to internal knowledge of the products and therapies. Stay abreast with relevant clinical literature. In collaboration with internal and external stakeholders define and implement a publication pipeline.
  • Provide medical input on Risk-Benefit analysis on products and therapies, including pre- and post-market activities. Assist in preparation of Clinical Evaluation Reports (CERs) and Post-Market Surveillance reports.
  • Participate in regulatory and legal review of internal and external documentation.
  • Answer questions from physicians regarding off-label inquiries to allow physicians to make clinical decisions for the patients.
  • Support sponsored clinical studies, as well as external Investigator Initiated Studies:

    • Provide medical background information for new disease areas.
    • Perform routine Safety Surveillance across sponsored studies.
    • Participate in preparation for FDA meetings and negotiation with FDA on study protocols. Assist in final study reports.
  • Assist in development of Key Opinion Leaders, including but not limited to education and communication.
  • Help plan and actively participate in advisory boards. Represent company at Medical Societies meetings, Grand rounds, Payer meetings, meetings with Health Authorities, and other events.
  • Manage and direct outside Medical consultants to meet objectives.
  • Physician resource for medical education and competitive products and other related areas.
Knowledge, Skill, and Abilities:

  • Excellent written and verbal communication skills
  • Excellent interpersonal skills
  • Travel up to 40%
Education and Experience:

  • Medical Degree with Board Certification in Psychiatry or Neurology
  • Understanding clinical trial design and top level statistics
  • Hands on experience in clinical research
  • Experience in writing scientific papers and in podium presentations
Preferred Skills:

  • Ideal candidate has experience with TMS therapy
  • At list 5 years of experience with Pharma or Medical Devices in the area of Psychiatry or Neurology.

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