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 Job #03161 Email this job to a friend
About our client
Our client is a specialty CRO headquartered in the Midwest that is experiencing unprecedented growth. The company has an experienced management team, an exceptional reputation with their clients and an empowering corporate culture that is focused on rewarding the effort and achievements of employees. This is a strong opportunity for someone that wants to put their drive and initiative to work!
Position Location
Medical Director Georgia
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Oversee medical monitoring of clinical trials
2) Provide scientific and medical expertise for clinical trials as well as consulting projects
3) Act as a medical resource for staff members
4) Review and manage Serious Adverse Events (SAEs) during clinical trials
5) Participate in management of SAEs
6) Interact with the FDA and participate in advisory boards
7) Participate in developing and reviewing scientific writing projects
8) Develop and review study protocols, study reports, manuscripts, monographs, FDA briefing documents and regulatory analyses
9) Create and conduct employee training/continued education
10) Attend capabilities presentations and make client visits (as needed)
11) Identify potential areas of business development and client expansion
12) Manage clinical projects in overseas locations, particularly India
Requirements
1) MD with US Medical License and training
2) Minimum 5 years of hematology, oncology, immunology, nephrology or hepatology sub-specialty experience
3) 2+ years of pharmaceutical, biotech industry or CRO experience a plus
4) Stem cell/transplant experience a plus
5) Experience in clinical trials (either as a Medical Director or Investigator)
6) Experience in leading clinical and cross-functional teams
7) Knowledge of GCP and ICH guidelines
8) Willingness to travel (primarily) to Asian countries (up to 50%)

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