Michael Stecher Email & Phone Number

Kirkland, Wa, Us

New York, New York, Us

Bothell, Washington, Us

Bothell, Washington, Us

Austin, Texas, Us

Duties:➢ Provide medical oversight in the evaluation, management and follow up of patient enrollment, serious adverse event reporting, and efficacy data for 6 completed clinical trials, and three that are currently ongoing.➢ Review data listings of safety data, including adverse experiences, laboratory data, and vital signs data, to establish the presence or absence of abnormal trends, and if noted, follow up as appropriate with the project team, investigator, and the Food and Drug Administration (FDA).➢ Administer protocol specific training to Principal Investigators during site initiation visits and investigator meetings.➢ Act as medical science liaison with Investigators and KOLs regarding scientific rationale and mechanism of action for the company’s investigational agent.➢ Provide medical consultation as required or requested to Investigational site.➢ Ensure 21 Code of Federal Regulations (CFR) part 312.32, are followed for reporting serious and related adverse events➢ Review and approve confidentiality agreements, clinical trials contracts, investigative site and vendor budgets.➢ Review and select vendors such as contract research organizations, central laboratories, etc.➢ Author Clinical Trial Protocols and Investigator’s Brochures for investigational agent.➢ Design and review of case report forms. ➢ Author sections of the Common Technical Document for Investigational New Drug (IND) submissions to the FDA, SwissMedic, and European Medicines Agency (EMA).➢ Prepare Annual Safety Reports and Clinical Study Reports for the FDA or other regulatory agencies on a periodic and regular basis summarizing adverse experiences as required by the competent authorities.➢ Attend FDA and EMA meetings, both face to face and teleconference, as the medical representative for the company. Summarize results of clinical trials; answer regulatory, scientific and medical questions; propose rationales

Doctor Of Medicine (Md)

Bs, Biology, General