Medical Director, Safety

Pennsylvania
4822
Our client is a biotechnology company. They have asked us to assist them in a search for a Medical Director, Safety.

  Major tasks and responsibilities include:
  • Leads safety profile through all phases of the life-cycle.
  • Guides the clinical development teams regarding all aspects of clinical safety, including trial design, appropriateness of safety endpoints, analysis and interpretation of safety data.
  • Liaises with KOLs, sets up and coordinates Advisory Boards and Drug Safety Monitoring Boards. Is accountable for timely delivery of all safety deliverables towards Clinical Study Reports, preparations for market applications and all other regulatory documents.
  • Leads multidisciplinary teams (e.g. Safety Management Teams) regarding safety relevant topics and escalate all safety relevant matters to the appropriate decision making level with proposals for solutions based on analysis of the available information.
  • Acts as safety expert providing strategic input to key stake holders in relation to product safety, understands the business strategy for the product and is knowledgeable about the (medical) context of the respective product class.
  • Performs investigations into safety profile of potential new product acquisitions and ensures that all necessary requirements are included in PV agreements, and also acts as safety liaison to license partners.
  • Participates actively in continuous improvements of quality of processes, methods and communication.
  • Reviews and contributes to safety relevant SOP and improvement of safety relevant SOPs.
  • Interfaces with other departments regarding safety aspects.
  • Acts as the subject matter expert for safety relevant discussions with other external bodies.
  • Provides expert advice to legal counsel regarding safety issues.
  • Is a part of clinical safety risk management relevant training and mentoring.
  • Analyzes and prepares safety data for manuscript and/or publication submissions.
  • Contributes to quality improvement: Reviews, prepares, and/or updates local and global SOPs and working instructions as required.
 
We seek candidates with the following qualifications:
  • Must have a Medical Degree plus accredited residency.
  • Requires 2+ years of experience as a physician in patient care.
  • Requires 3+ years of pharmaceutical / biotechnology industry experience, with one including accountability for medical oversight/evaluation or clinical development.
  • Industry experience in designated therapeutic area(s) is required.
  • Must have experience and success in addressing and managing complex medical issues in the pre-approval and post-approval environment.
 
If interested, please apply directly to this job posting. 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.
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