FierceBiotech and FiercePharma Jobs
Medical Director Infectious Disease - MR-Raleigh
Categories: Clinical
Position Description
My west coast southern California biopharmaceutical company is focused on the discovery, development and commercialization of innovative antibiotics.
Medical Director Infectious Disease
OBJECTIVE:
This position reports directly into the Chief Medical Officer (CMO) and manages the integrated development strategy and the resultant tactical clinical plan and study designs to support the global development of and establish the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of multiple compounds.
The position has the overall responsibility of monitoring the progress of development and safety of the assigned compounds resulting ultimately in regulatory submissions.
This position has the overall responsibility for the scientific design, data interpretation and reporting of Phase I-IV clinical trials for assigned compounds.
Acts as the medical monitor for the clinical studies.
ACCOUNTABILITIES:
Accountable for a large-scale highly complex program including multiple indications or multiple programs.
* Provides overall direction, scientific expertise, and management of results for ongoing internal studies and external research to optimize the development strategy and the resultant tactical clinical plans required to support global development of the assigned compounds
* Feasibility Assessment: Lead the creation of the product development plan, including the design of all the clinical studies. Establishes, through the development plan, the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of candidate compound. Lead the recruitment of and communication with clinical opinion leaders during the plan development process.
* Project Progress: Anticipates or Identifies project needs and maintains a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements.
Qualifications
EDUCATION, EXPERIENCE, AND SKILLS:
Required:
* MD plus 5 years of clinical research experience in antifectives within the pharmaceutical industry, CRO health-related consulting company.
Michael A. Terretti
Vice President
Managing Director
Global Life Sciences
919-781-0400×112 office
mterretti@mriraleigh.com




