Senior Medical Director - Rheumatology

16 hours ago

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• The Medical Director will provide medical support and medical advice for clinical trials and safety evaluation within the Pharmacovigilance department. • Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information. • Contribute to site selection, involved in review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs). • Ensure medical validity of each individual primary endpoint as well study subject safety. • Pro-active customer concern and correction of issues in consultation with the Global Medical Indication Lead. • Consult with internal groups and support staff regarding procedural and budgetary items and address issues timely and effectively. • Educates Investigator sites by delivering a protocol specific lab procedures presentation and demonstration during an investigator meeting. • Medical point of contact for all internal and external stakeholders. • Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP. • Closely collaborate with the cross functional study team members to clarify medical risks, issues, and results.

Requirements

• Education MD, MB/BS or equivalent degree and strong medical knowledge • Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine is critically important • Is fluent in spoken and written English • Strong communication & presentation skills and is a strong teammate • Shown understanding and experience with NDA submission process • Shown understanding of regulatory guidelines for adverse event reporting