Senior Executive- Pharmacokinetics

Conduct scientific literature searches and design Bioavailability and Bioequivalence (BA/BE) studies for oral and non-oral dosage forms targeted toward global regulatory submissions (US FDA, EMA, DCGI/CDSCO).

Review clinical BA/BE protocols and integrate critical pharmacokinetic (PK) inputs, sampling schedules, and dosing rationale.

Develop study protocols for patient-based BA/BE studies and pharmacodynamic (PD) endpoint trials for complex generic formulations.

Coordinate closely with domestic and international Clinical Research Organizations (CROs) to finalize pilot and pivotal biostudy protocols and ensure compliance for DCGI BE applications.

Supervise trial execution and monitor trial timelines with CRO partners.

Perform non-compartmental and compartmental PK/statistical analyses on in-vivo trial data using standard modeling software (Phoenix WinNonlin).

Author comprehensive pharmacokinetic summary reports, integrated clinical study sections, and regulatory response documents for global health authorities.