Our client is a leading, high growth biotechnology company. They have asked us to assist them in a search for a Medical Director.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Contributes to the design, analysis and reporting of clinical studies. Activities to include protocol writing, study conduct oversight according to best practice and national and international guidelines and regulations, as well as objectives and standard operating procedures (SOPs).
- Works closely with the Therapeutic Head of Rare Disease VP role to ensure robust protocols and appropriate study oversight.
- Acts as standing member of clinical trial and post marketing safety review groups as well as the product development teams.
- Provides input into and reviews key internal and external reports.
- Demonstrates ability to interact with study site investigators regarding subject eligibility, dosing, safety and other clinical trial conduct issues as needed.
- Contributes as needed to key safety documents.
- Provides clinical-scientific input into the development of relevant documents.
- Provides guidance to managers before, throughout, and following clinical trials to ensure compliance for proper study conduct throughout clinical trials.
- Collaborates with colleagues to review ongoing data from clinical trials.
- Reviews non-clinical data as required.
- Reviews clinical pharmacology data as required.
- Reviews post-marketing safety data to support reviews of the product safety portfolio.
- Participates in evaluation of life cycle management opportunities.
- Supports development of medical affairs materials, based on clinical trial datasets.
- Participate in due diligence activities as requested.
- A Medical Degree is required
- Must have at least 5 years of biotech/pharmaceutical experience in clinical development related activities.
- Requires the demonstrated ability to work cross functionally in a matrixed environment.
- Statistics and clinical operations collaboration experience is required.
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.
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