F. Naureen Sheikh

About F. Naureen Sheikh

Experienced and accomplished Clinical Research professional having focused for 2 decades on medical research and clinical trial conduct. Adept at aligning strategic plans and protocol development with execution of clinical trials to obtain pre and post market approval for Phase I through Phase IV pharmaceuticals and medical devices. Extensive and solid study management, supervisory, clinical training and program management roles. Global clinical experience in developing clinical strategies, in collaboration with FDA and US reimbursement government healthcare bodies. Strong leadership skills based on building results orientated, high performance organizations; targeted on team building, talent development and performance management. Major Accomplishments• Established and directed teams to provide critical data for the FDA Pre-Market Approval and the US launch of Medtronic’s first coronary drug eluting stent (ENDEAVOR) resulting in a $81 million revenue in the first 3 months.• Managed the largest randomized and blinded drug eluting stent trial in the history of Medtronic CardioVascular.• Implemented a unique cross functional collaboration with the Medtronic Cardiac Rhythm Disease Management Field Clinical Engineer (CRDM FCE) and Clinical groups to accelerate investigational site activation and patient enrolment.• Recognized for developing high performance clinical research teams resulting in reducing costs, shortening project timelines and improving quality.

Experience

1. Head of Clinical Development Fi

   Intuitive

   Jan 2024 — Present · Sunnyvale, CA, US

   Developing fluorescent imaging molecules to be used in Da Vinci robotic assisted surgery. Indications for use include aiding in identification of (1)residual and metastatic prostate cancer and (2)intraoperative gynecological and colorectal procedures for ureter delineation.

Education

• University of Dundee

  Master of Science - MS, Analytical Biochemistry

• University of Wales College of Medicine, Cardiff. Wales

  PhD, Biochemistry and Molecular Biology

• University of Wales, College of Cardiff

  Bachelor's degree (Hons), Microbiology

Skills

• Ich-Gcp
• Clinical Trials
• Edc
• Ctms
• Regulatory Submissions
• Cross-Functional Team Leadership
• Cardiology
• Clinical Development
• Medical Devices
• Clinical Research
• Capa
• Design Control
• Gcp
• Oncology
• Protocol
• Clinical Operations
• 21 Cfr Part 11
• Biotechnology
• Clinical Data Management
• Clinical Study Design
• U.s. Food and Drug Administration (Fda)
• Medicine
• CRO
• Regulatory Affairs
• Lifesciences
• Pharmaceutical Industry
• Sop
• Fda
• Healthcare
• Neurology
• Clinical Monitoring
• Clinical Trial Management System (Ctms)