Ghaith Mitri
- Role
- Sr Medical Director, Clinical Development, Rheumatology & Rare Diseases at Alexion Pharmaceuticals, Inc.
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Ghaith Mitri
Dr. Mitri is an ABIM certified rheumatologist/ clinical immunologist with active licenses…
Experience
Sr Medical Director, Clinical Development, Rheumatology & Rare Diseases
Dec 2022 — Present
December 2022 – April 2023 (Consultant) April 2023 – Present (Full-Time) • Represent Clinical Development on the Global Program Team (GPT) and in presentations at management and review committees • Supervise and develop Med Directors and Clin Dev Scientists and/or fellows; Lead a clinical sub-team and oversee the preparation of a clinical development strategy. May lead one or more clinical study teams in the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents • Might serve as medical monitor, and provide medical input to relevant documents (e.g, IB, IMPD, DSUR, SUSAR, IND, NDA/BLA, PIP, etc.) • Oversee interpretation and dissemination of study results, including clinical study reports and related publications as well as present data at conferences and other scientific or regulatory forums • Partner with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and company SOPs • Determine appropriate advisory boards experts and lead the team in preparation for meetings • Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy • Serve as the Medical input to the Global Development Team / Sub-team and the Medical Expert for the Clinical Development Team / Sub-team and the Medical Expert for clinical study team • Liaise internally with other members of the clinical development team (including Clin Dev Scientists) to drive overall program strategy and development plans • Support business development activities, such as due diligence and research collaborations • May serve as the Translational Science lead for one or more programs
Education
Damascus University
MD, Medicine
1989 — 1995
USC Marshall School of Business
EMBA/MMM, Entrepreneurship & Healthcare Leadership & strategy
2006 — 2007
Scranton Temple University Residency Program
Internal Medicine Residency, Internal Medicine
1996 — 1999
University of Pittsburgh School of Medicine
Rheumatology & Clinical Immunology Fellowship Training, Rheumatology & Clinical Immunology
1999 — 2001
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