About Sudipta Basu
Sudipta Basu works as Global Clinical Director, Singapore at Abbott and is based in Singapore, Singapore. Sudipta studied Doctor of Philosophy (Pharmacy) at Jawaharlal Nehru Technological University (2009-2014). Sudipta lists talents in Pharmacist, Biomedical Scientist, Analytical Chemistry and Pharma Research.
Talents
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Clinical... among ... users in Singapore…among … users worldwide -
Pharmacist... among ... users in Singapore…among … users worldwide -
Biomedical Scientist... among ... users in Singapore…among … users worldwide -
Analytical Chemistry... among ... users in Singapore…among … users worldwide
Professional Path
Global Clinical Director, Singapore
Abbott
Full Time
Aug-2016 To
present
10 years 1 months
- Working as a Global Clinical Director, responsible for clinical candidate proposals, critical clinical decisions, priority setting, study design, cost and timeline for various global studies. Develop state of the art clinical development programs for various compounds in compliance with applicable laws, regulatory guidelines, quality standards and company policies.
The clinical pharmacology and bioanalytical department of EPD (Established Pharmaceutical Division) are responsible for handling phase I studies for BE, BA, PK, PD, safety, DDI, Food Interaction, Bioanalytics, Special Populations, Late Phase Clinical Pharmacology, population PK.
Provide support for bioanalytical method development, method validation, sample analysis, reporting, central lab, kits supplies and laboratory manual preparation for various global clinical studies. Product dossier preparation and support for various countries. Population PK, PK/PD & IVIVC support.
Associate Director-Clinical Development
Dec-2013 To
Jul-2016
2 years 7 months
- Worked as as Associated Director-Biologics-Clinical Development (CD). Managed three verticals - Act as a lead for Clinical Trial, Lab Operations lead and NBE program lead from CD at Dr. Reddy’s Laboratories, Hyderabad.
Clinical Operational lead for CT: Strategy, Investigator/CRO selection, CDA/contract/MSA execution, Protocol, ICF, CRF preparation, execution of biosimilar clinical trials, CSR, regulatory, monitoring, budget and expenses, CSR finalization etc.
Lab Operation Lead: Overall responsible for all biosimilar CT sample analysis, method validation (PK, ADA, Nab, PD etc) identification & selections of CRO, audit/monitoring, technology transfer and coordination of out-sourced clinical trials bioanalysis in various global CRO, selection of diagnostic/safety-central lab, sample movement and logistic, budget/invoicing, planning and strategy.
New Biological Entity (NBE) Development: Act as a clinical development and lab lead for new biosimilar/bio-better development program.
Head-Bioanalytical, Analytical and Radio-lab
Sai Life Sciences Ltd, Pune, India
Full Time
Jul-2008 To
Dec-2013
5 years 5 months
- Managing Entire analytical laboratory related activities. People management, Financial and Administrative Management.
DMPK, Pre-clinical drug discovery research, Bioanalytical, in-vitro assay, Pharmacokinetics. - Best Team Award in FY-2012-2013.
Best Performer award-2012
Group Leader-Bioanalytical Lab
sun pharma
Full Time
Apr-2007 To
Jun-2008
1 years 2 months
- Managing a team of 10-12 scientists for BA/BE analytical/bioanalytical related activities, GLP/Preclinical related activities.
Research Associate
Wockhardt Pharma, Mumbai, India
Full Time
May-2005 To
Apr-2007
1 years 11 months
- Managing a team of 4 people. Handled LC-MS/MS, HPLC, UPLC, ELISA, Spectromax etc.
- Best Performer Award-2006
Research Associate
Aug-2001 To
Jul-2003
1 years 11 months
- Handling Clinical Trails related activities, Protocol writing, Execution of Clinical Trails, DCGI, US-FDA audit
» 1 Project
Qualifications
Jawaharlal Nehru Technological University
Doctor of Philosophy Pharmacy
2009-2014
-%
The Maharaja Sayajirao University Of Baroda
Master of Pharmacy Pharmaceutics
2003-2005
68%
Amrutvahini Institute of Management and Business Administration
Bachelor of Pharmacy Pharmacy
1998-2001
79%
2nd Topper in the University
My Story
Global Clinical Director, responsible for clinical candidate proposals, critical clinical decisions, priority setting, study design, cost and timeline for various global studies. Develop state of the art clinical development programs for various compounds in compliance with applicable laws, regulatory guidelines, quality standards and company policies. Hands on experience in LC-MS/MS, ELISA, Small and Large molecule bioanalysis and Pharmacokinetics. Having a very good understanding of Biosimilar
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Other people named Sudipta
- Sudipta Das, Hooghly
- Sudipta Halder, Kolkata
- Sudipta Das, Kolkata
- Sudipta Saikia, Tezpur
- Sudipta Ghosh, Howrah
- Sudipta Singh, Indore
- Sudipta Roy, Kolkata
- Sudipta Kumar Bakshi, Kolkata
