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Clinical Trials Manager |
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Senior Scientist (metabolomics) |
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QA Auditor |
| Responsibilities:
Performs internal and external cGMP audits ensuring compliance with all Food and ... |
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QC Bioassay Analyst |
| Responsibilities:
Responsible for the performance of cell-based potency bioassay, ELISA and ... |
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Quality, Process and Training Specialist |
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Intellectual Property Administrative Assistant |
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Senior Medical Director/ Medical Director
| Details |
Country: USA
Location: Massachusetts-Boston Cambridge, MA 02139
Total applied: 14 Job Category:Medical/Health
Relevant Work Experience:2+ to 5 Years
Education Level:Doctorate
Location:Cambridge, MA 02139
Status:Full Time, Employee
Occupations:Medical Practitioner;General/Other: Medical/Health
Relevant Work Experience:2+ to 5 Years
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Senior Medical Director/ Medical Director
Job Description
We are currently seeking an experienced pharmaceutical industry physician to join our growing Clinical Development Department as a Sr. Medical Director or Medical Director, title commensurate with experience.
Key responsibilities for the Sr. Medical Director/Medical Director include:Participating in the strategic planning (including study design, method selection, etc) of Phase I through IV clinical trials.Taking responsibility for the execution and management of Phase I through IV clinical trials.Serving as the clinical representative on project teams for products in early development.Interpreting data, and being responsible for data collection activities Providing medical monitoring for clinical trials.Assisting with medical evaluation of in-licensing activities.Participating in vendor selection activities.Contributing to, reviewing, and approving clinical regulatory documents (clinical study reports, regulatory submission sections, investigator’s brochures, etc.) .Presenting ideas and results both orally and in written format to project teams, senior management, partners, regulatory authorities, etc.Mentoring junior team members, and providing guidance and opportunity for their professional development.
Minimum Education & Experience Requirements: MD with at least three years of pharmaceutical drug development experience. Expertise in Psychiatry, Addiction Medicine or Pulmonary Medicine, a plus.
Knowledge/Skills Needed: Excellent verbal and written communication skills and a strong scientific background with industry drug development experience are required. The Sr.Medical Director/Medical Director will need to work with a global team of colleagues within Clinical Development (Drug Safety, Biostatistics and Data Management, Medical Writing), Clinical Pharmacology, and Regulatory Affairs.
Limited travel (approximately 10-20%) is required.
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