FierceBiotech and FiercePharma Jobs
Medical Director, Clinical - Vaccines - Advantage ONE Executive Search
Nov 04
Location: Washington, Categories: Clinical
Position Description
Medical Director, Clinical – Vaccines
Greater Washington, DC Area
Our client is engaged in the discovery and development of new human therapeutics and prophylactics for the treatment and prevention of morbidity and mortality from exposure to chemical and biological weapons. Currently there are two products under development and the company intends to identify and develop dual-use technologies which have applications and indications in broader commercial markets.
The Medical Director, will be responsible for the design, oversight, and execution of the clinical trial program for vaccine candidates. This will include medical monitoring, interactions with FDA, CDC, BARDA, and NIH as well as the Safety Monitoring Committee and internal project team.
- Develop the clinical trial program for vaccine candidates in conjunction with relevant members of the Project Team.
- Ensure that the clinical and non-clinical plans are harmonized in order to meet both safety and efficacy requirements for those vaccines being developed.
- Provide input for the design of each individual clinical trial and oversee protocol development, IRB submission, and GCP compliance.
- Serve as Medical Monitor as appropriate for each active clinical trial and work with the regulatory group to ensure compliance with adverse event reporting requirements.
- Work with the Clinical Operations group to insure on-time, on-budget execution of each vaccine clinical trial.
Must be a licensed Medical Doctor. Knowledge of Good Clinical Practice guidelines and procedures. Five + years industry experience in clinical trial design and execution. Experienced in medical monitoring/managing multi-site, large clinical trials. Experienced in FDA interactions related to design and execution of the clinical program. Experience with vaccine clinical trials or experience in the biodefense industry is highly desired. Need ability to identify problems, research contributing factors, and develop and implement recommendations for resolution in a proactive problem solving approach.
If fully qualified, reply in confidence to lvaughn@advantage-search.com with your cv attached as an MS Word doc.
