Mareena Biju
Clinical Pharmacology Post-Doctoral Fellow at Boehringer Ingelheim
- Role
- Post-doctoral Clinical Pharmacology Fellow at Boehringer Ingelheim
- Location
- Danbury, CT, US
- LinkedIn followers
- 500 followers
About Mareena Biju
Clinical pharmacologist and PharmD with three years of industry experience supporting early-phase drug development across small molecules, peptides, and biologics at Boehringer Ingelheim. Served as the responsible trial clinical pharmacologist on Phase 1 studies spanning first-in-human, thorough QT, renal impairment, drug-drug interaction, and relative bioavailability trials, with end-to-end ownership of PK deliverables, from NCA and CDISC-compliant dataset generation to SAP authorship, CSR writing, and regulatory submission support. Contributed to pre-IND packages, Investigator\'s Brochures, and cross-functional dose escalation discussions. Extends scientific contributions beyond trial work through research in immunogenicity assessment, real-world data-based DDI evaluation, and AI/ML-enabled covariate selection, with two manuscripts under review and multiple presentations at ACCP. Also brings prior experience from clinical pharmacology internships at the FDA (oncology) and Pfizer. Proficient in Phoenix WinNonlin, R, NONMEM, SAS, and GastroPlus.
Experience
Post-doctoral Clinical Pharmacology Fellow
Jul 2024 — Present · Ridgefield, CT, US
Education
USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences
Doctor of Pharmacy - PharmD, Pharmacy
2020 — 2024
UC Irvine
Bachelor's degree, Pharmaceutical Sciences
2016 — 2019
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