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Job Description - Senior Medical Director
Description: We are seeking a Senior Medical Director who will be based in our Waltham office and responsible for providing oversight of investigational drug safety, overall clinical trials data and safety monitoring. Reporting to the Chief Medical Officer, this position has responsibility for helping develop clinical strategy and for implementing the clinical development programs in ophthalmology and oncology, which includes designing and writing clinical protocols implementing data collection systems, and leading clinical and safety study report writing for submission.
Responsibilities:
Provide medical safety monitoring for ongoing clinical trials.
Review and interpret clinical data on a real-time basis in collaboration with Oxigene clinical staff and vendors.
Review SAE reports from clinical sites to determine if an IND Safety Report is needed.
Responsible for the proper conduct of Safety Review Meetings for investigational drugs.
Assure, in conjunction with Regulatory Affairs, compliance with regulatory reporting requirements for safety reporting in clinical trials, domestically and internationally.
Provide expertise for developing procedures to capture, manage, and report clinical trial safety data.
Participate in protocol development, specifically protocol design and statistical analysis plans.
Serve on assigned project/product teams to provide guidance regarding medical/safety-related issues.
Interact with various key opinion leaders in the field and identify appropriate investigators and study sites to conduct clinical trials.
Requirements: A MD degree is required. At least 3-5 years clinical development experience in industry is preferred. Board certified or board eligible in ophthalmology and/or oncology relevant field is desirable. Candidate must have fundamental understanding of drug clinical development and regul |
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