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Hrishikesh Kansara

@hrishikeshkansara

I design pharmacokinetic clinical studies and regulatory programs supporting drug development, bioequivalence, and pharmacometric analysis.

India

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What I'm looking for

I'm looking to lead pharmacokinetic and scientific-affairs work supporting clinical development, regulatory submissions, study design, PK/PD analysis, and evidence-based decisions for small molecules, large molecules, and biosimilars.

I'm an Associate Director of Pharmacokinetics and Scientific Affairs at Cliantha Research, providing clinical input for ANDAs, INDs, 505(b)(2) NDAs, and BLA applications.

I design Phase I, SAD, MAD, DDI, patient PK, and animal PK studies, prepare SAPs and PK/PD plans, and perform pharmacokinetic analysis in Phoenix WinNonlin. I also calculate sample sizes using SAS and R and interpret study results to guide next steps.

Previously, I audited pharmacokinetic, statistical, POPPK, and clinical-study data at Lambda Therapeutic Research, including in-process and retrospective study audits, system audits, protocol reviews, and regulatory queries.

Across Torrent Research Centre and Veeda Clinical Research, I supported bioequivalence study design, clinical monitoring, statistical interpretation, dossier preparation, ICH-GCP compliance, and audit readiness. I bring 15+ years of clinical research experience in regulated markets.

Experience

Work history, roles, and key accomplishments

Current

Associate Director-Pharmacokinetic and Scientific Affairs

Current

Cliantha Research

Oct 2017 - Present (8 years 11 months)

Provides clinical input for drug applications including ANDAs, INDs, and 505(b)(2) NDAs. Designs clinical studies, prepares SAP/PK-PD plans, and performs pharmacokinetic analysis using Phoenix WinNonlin.

Phoenix WinNonlin (Elementary)SAS R RStudio Clinical Trial Design SAP PK PD Analysis Regulatory Affairs FDA ANDA IND NDA BLAs Biosimilars Skin Blanching Studies Clinical Study Report (CSR)SOPs

Auditor-Pharmacokinetics

Lambda Therapeutic Research

Apr 2015 - Oct 2017 (2 years 6 months)

Audited pharmacokinetics and statistics data of clinical studies, in-vitro studies, and patient-based PK studies. Reviewed SAS and Phoenix WinNonlin data and handled regulatory queries.

Audit Pharmacokinetics Statistics SAS Phoenix WinNonlin (Elementary)Population PK Regulatory Inquiries SOPs

Scientist-II

Torrent Research Centre

Sep 2013 - Apr 2015 (1 year 7 months)

Conducted literature review, new product evaluation, and BE study design. Provided statistical analysis and interpretation of BE results and prepared clinical and non-clinical overviews for dossier submissions.

Bioequivalence Studies Statistical Analysis Clinical Trial Design ICH GCP Regulatory Submissions Project Management Ethics Committees SOPs

Sr. Research Associate

Veeda Clinical Research

Sep 2009 - Aug 2013 (3 years 11 months)

Monitored clinical studies ensuring compliance with protocol, ICH-GCP, and SOPs. Reviewed Trial Master Files, source data, and draft reports, and resolved queries from QAD and sponsors.

Clinical Monitoring ICH GCP Trial Master File Source Data Review (SDR)Report Generation Regulatory Audits