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Sachin Marulkar

Clinical Development • Medical Director • Quantitative Sciences • Biometrics • Alexion Pharmaceuticals

Sachin Marulkar, MD, MPH, MBA, is a seasoned drug development professional with over 20 years of experience in clinical, quantitative sciences, and data analytics supporting a wide range of clinical trials in therapeutic areas such as rare diseases, hematology, transplantation, metabolic disorders, cardiovascular and neurological devices.

He possesses a strong industry background offering strategic insights in clinical development, study designs, statistical methodology, operational planning, budget planning, product life cycle, and program management.

With expertise in team building and CRO management, Sachin has extensive regulatory experience in submitting NDA/BLA and collaborating with regulatory bodies such as FDA, EMA, PMDA, and Health Canada.

As a team player, he collaborates effectively with various departments including clinical operations, biometrics, medical affairs, commercial, medical writing, pharmacovigilance, regulatory affairs, and clinical pharmacokinetic/pharmacodynamics.

Sachin has also demonstrated his capabilities as a Functional Representative on due-diligence committees and has led the functional integration process in multiple acquisitions.

Education wise, he holds an MBA from Massachusetts Institute of Technology, an MPH in Biostatistics and Epidemiology from Boston University, and an MD from MGM/KEM Hospital.

Sachin has held key positions in renowned organizations including Director, Clinical Development at Alexion Pharmaceuticals, Scientific Advisory Board Member at Genpro Research Inc, Director of Quantitative Sciences at Alexion Pharmaceuticals, Inc., and Associate Director of Clinical Data Sciences and Informatics at Sanofi Genzyme.

Prior to these roles, he has served as a Senior Epidemiologist and Biostatistician at the Harvard Clinical Research Institute, Clinical Research Associate at Boston Children's Hospital, Clinical Research Associate at KEM Hospital Diabetic Research Center, and Resident Intern at KEM Hospital Pune.

Sachin Marulkar
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Location

Greater Boston