Quality Recruiting. Established Experts.

Medical Director/Senior Medical Director, Clinical Affairs

Reference Number: 3936
Location: CA / WA

Our client is a clinical-stage biotechnology company. They have asked us to assist them in their search for a Medical Director/Senior Medical Director, Clinical Affairs.

Major tasks and responsibilities will include:

  • Contributes to the overall clinical development program strategy, planning and execution, including, but not limited to, clinical trial monitoring and data collection activities, writing protocols and study reports, clinical development plans designed to enable creative and effective regulatory strategies, and safety monitoring and reporting.
  • Supports and oversees teams involved with clinical trial planning, protocol development, investigator selection, training of internal and external personnel, medical monitoring, clinical study event review and approval, data analysis and interpretation, quality control, and presentation/publication.
  • Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. 
  • May recruit clinical investigators and develop study design.
  • Directs human clinical trials, Phases I – IV, for company products under development. 
  • Coordinates and develops information for reports submitted to the Food and Drug Administration.
  • Monitors adherence to protocols and determines study completion.  May act as consultant/liaison with other corporations when working under licensing agreements.  
  • Effectively communicates data through publications and presentations and participates in team discussions.
  • Maintains appropriate and accurate records of data.
  • Attends and participates in local, national, and international medical conferences.
  • Performs other responsibilities as assigned.

We seek candidates with the following qualifications: 

  • MD degree required.
  • Board eligibility or certification in oncology or hematology highly preferred.
  • Requires a minimum of 5 years of experience with clinical trials in the pharmaceutical industry.
  • Must have knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements.
  • Proven experience in medical writing required.
  • Requires a strong leadership presence.   
  • Strong work ethic, unimpeachable ethics and honesty required.
  • Must have strong communication and presentation skills.
  • Requires the ability to travel overnight up to 30%, as necessary, consistent with project needs.

If interested, please email your resume as a Word attachment to us, reference 3936.  No calls 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.