Experience: 18+ years, with 12 years in designing and conducting Phase I – IV clinical trials for small molecules and biosimilars. Shiv is a time-proven expert in conducting oncology- clinical trials. He has spearheaded the clinical development efforts for first-in-the-world Biosimilar – ‘mab’, and has led two major trials – one for long-acting erythropoietin analogue, and the other for long-acting growth factor. With his previous engagements, he has successfully established project management processes and systems, and formulated multi-level governance structure for strategic alliances.
For over twelve years, Shiv has led multiple clinical trials for global development of clinical trials, with primary responsibility of design, planning and execution of the trials. He has been involved in developing four extended release formulations in GI, Diabetic, Cardiac and CNS segment. Additionally, he conducted multiple Phase II and III clinical trials for domestic filing with projects in the GI, Diabetic & Metabolic disorders and Cardiac segment.
Further, he has conducted/overseen 100+ BA/BE studies for emerging & regulatory market filings, and for development of Novel Drug Delivery Systems.
Shiv is an efficient technical interface between the medical and clinical operations teams, and is the co-author of three research publications, with numerous awards for his contributions.
At present, at IDRS Labs, as a Managing Director of the company, Shiv is responsible for overall governance of the company and has direct reports of critical functions like Quality Assurance, HR, IT and PMO.