F. Sandra Siami, MPH
Vice President, Clinical, Regulatory, Quality
Sandra Siami is Vice President overseeing all clinical research, regulatory affairs, and quality assurance activities. She has a proven track-record for providing strategic corporate business development direction to support organizational objectives and serves in an executive leadership role. She is known for her innovative, out of the box solutions to overcome business changes and risks associated with this industry. Ms. Siami is responsible for establishing business relationships for NERI’s CRO services.
Ms. Siami has over 20 years of experience in the Pharma and Medical Device industries and has directed trial and registry initiatives across a variety of therapeutic areas, most predominately cardiovascular. She leads pharmacovigilance and medical device safety activities, as well as medical writing. She has collaborated with regulatory agencies and competent authorities in over 30 countries. And oversees QA activities including quality systems, internal & supplier audits, enterprise-wide policies, and compliance.
Ms. Siami has received several awards relating to her scientific capabilities, including the ASAIO Kolff Young Investigator Award. She has served leadership roles at RAPS including being Senior Faculty and Chair of the Ethic Committee. She is well published and has served on the editorial boards and reviewer for several major medical journals including ASAIO Journal, NEJM, and JAMA. She has made major contributions to the field of orphan devices, rare diseases, and pediatric research.