Kuntal Sinha
About Kuntal Sinha
Kuntal Sinha is the Director of Clinical Quality Assurance at Alkermes, specializing in pharmacovigilance, medical affairs, and commercial sectors.
Current Role at Alkermes
Kuntal Sinha is currently the Director of Clinical Quality Assurance (Pharmacovigilance, Medical Affairs, and Commercial) at Alkermes, based in Waltham, MA. In this role, Sinha is responsible for ensuring adherence to clinical quality standards across pharmacovigilance, medical affairs, and commercial sectors within the company. This involves developing and implementing quality assurance strategies to meet regulatory requirements and enhance process efficiency.
Previous Role at Shire
From 2016 to 2017, Kuntal Sinha served as the Clinical and Post-Marketing Safety Leader in Global Safety and International QA and Compliance at Shire in the Greater Boston Area. During this period, Sinha was tasked with overseeing clinical safety and post-marketing surveillance activities, ensuring compliance with international quality standards and regulatory guidelines.
Career at Pfizer
Kuntal Sinha held multiple positions at Pfizer over a span of 14 years. From 2011 to 2016, Sinha was the Associate Director of Medical Quality Assurance in Groton, CT, where they focused on the development and execution of quality assurance protocols. Prior to this, Sinha served as a Senior Scientist/Manager in Clinical Pharmacology - Clinical Assay from 2002 to 2010, where responsibilities included managing clinical pharmacology projects and enhancing assay development.
Educational Background
Kuntal Sinha holds an MBA from the New York Institute of Technology, earned between 2000 and 2003, with a focus on management. Additionally, Sinha has a Master of Science (MS) and a Bachelor of Science (BS) in Bacteriology - Natural Science, both from the University of Wisconsin-Madison. The MS was completed in one year from 1994 to 1995, and the BS was attained over four years from 1985 to 1989.
Industry Expertise
Kuntal Sinha has developed significant expertise in clinical pharmacology, particularly in areas such as pharmacokinetics, pharmacodynamics, wet biomarkers, and drug metabolism. With experience in conducting routine and inspection-readiness audits for clinical investigator sites and specialty vendors, Sinha has a robust understanding of ICH/GCP and GLP guidelines. Their role has often involved substantial interactions with the FDA, including document preparation and query responses.