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Medical Director, U.S. Medical Affairs Specialty

Reference Number: 3813
Location: USA

Our client is a clinical research company.  They have asked us to assist them in their search for a Medical Director, U.S. Medical Affairs Specialty. 

Major tasks and responsibilities will include:

  • Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan.
  • Oversees project-related education of investigators, study site personnel, and study staff.
  • Oversees clinical studies, monitors overall study integrity, and reviews, interprets, and communicates accumulating data pertaining to safety and efficacy of the molecule.
  • Oversees study enrollment and overall timelines for key deliverables, along with Clinical Operations. 
  • Assesses and reports serious adverse events per policies and regulations for those protocols on which assigned.
  • Designs, analyses, interpret, and reports scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
  • Provides in-house clinical expertise for the molecule and disease.
  • Coordinates appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects.
  • Participates in due diligence or other business development activity, as appropriate.
  • Contributes in partnership with Discovery colleagues to design and implement translational strategies, as required by program needs.
  • Contributes to the development and review of abstracts, manuscripts for publications, scientific symposia presentations, and other medical documents as required.
  • Serves on a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches, as needed.
  • Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area.
  • Serves as a clinical representative for key regulatory discussions.
  • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and to all other quality standards in conducting research.

We seek candidates with the following qualifications:

  • Medical Doctorate (M.D.) degree or equivalent required, with national license to practice medicine and relevant therapeutic specialty in an academic or hospital environment.  Completion of residency and/or fellowship highly preferred.
  • Must have a minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry.
  • Requires proven leadership skills in a cross-functional global team environment.
  • Must be able to interact externally and internally to support global business strategy.
  • Required knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
  • Must be willing and able to travel up to 20%.

If interested, please email your resume as a Word attachment to us, reference 3813.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.