Khemraj Hirani

About Khemraj Hirani

Board-certified clinical Pharmacist and a Ph.D. in Pharmacology with a passion to advance clinical and regulatory milestones for product development. SME on FDA and CFR regulations related to clinical trials in endocrinology, HIV/AIDS, cancer, CNS, Biologics, cardiovascular and infectious diseases, vaccines, and safety updates. Filed regulatory dossiers and conducted several successful clinical trials with the privilege of leading a team of talented clinicians and support staff in those efforts. Over 25+ years to provide guidance and direction for clinical operations and research while performing oversight for regulatory compliance, quality assurance, and controls. Areas of expertise include Mentoring junior faculty and staff, Drug Development, Phase I to IV Trials, ICH/GCP Guidelines and FDA Regulations, Regulatory Dossier, Multiple Therapeutic Areas, Design of Research Protocol, Research Compliance, Data Safety Monitoring, Team Player and Problem Solving Skills, Communication Skills, Human Subject Protection, Pharmacovigilance, and Drug Safety.

Experience

1. Chief Regulatory Officer

   Signos

   Mar 2020 — Present · CA, US

   Signos is the only company that combines a CGM with an AI-driven app to deliver real-time glucose monitoring for optimal health and weight management. Signos translates an individual’s metabolic signals into timely recommendations for eating, exercise, and better health.

Education

• Mangalore University

  Bachelor of Pharmacy (B.Pharm.) at College of Pharmaceutical Sciences, Manipal, Pharmaceutical Sciences

  1994 — 1998

• Balaji Institute of Modern Management

  Post Gradute Diploma in Business Administration (PGDBM/MBA), Personnel Management and Business Administration

  2002 — 2003

• University of South Florida

  Postdoctoral fellowship, Pharmacology, Anatomy and Neuroscience

  2004 — 2006

• Nagpur University

  M.Pharm.-Ph.D. in Pharmacology, University Dept of Pharm Sciences, Faculty of Medicine, Pharmacology

  2001 — 2004

Skills

• Oncology
• Informatics
• Protocol
• Pharmacy
• Pharmaceutical Industry
• Sop
• Pharmacokinetics
• Fda
• Good Clinical Practice (Gcp)
• Healthcare
• Clinical Trials
• Biologics
• Research
• Human Subjects Research
• Biotechnology
• Regulatory Affairs
• Lifesciences
• Pharmacovigilance
• Gmp
• Clinical Development
• Neuroscience
• Quality Assurance
• In Vivo
• Strategic Alliances & Partnerships
• Leadership
• Drug Development
• Cancer
• Gcp
• Investigational Product Safety & Efficacy
• U.s. Food and Drug Administration (Fda)
• Medicine
• In Vitro
• Drugs
• Biophar
• Clinical Trial Operation
• Pharmacists
• Life Sciences
• Pharmacology
• Pharmaceutics
• Drug Discovery