Key Responsibilities
Develop and apply population PK and PK/PD (exposure–response) models to inform dose selection, optimization, and trial design (NONMEM, Monolix, or nlmixr2; R for data processing, simulation, and visualization).
Build and apply PBPK models (GastroPlus, or PK-Sim/MoBi) to predict drug–drug interactions, support special populations (organ impairment, pediatrics), and assess food effect, formulation changes, and first-in-human dose projection.
Conduct translational PK/PD: integrate in vitro and preclinical data (IVIVE, allometric scaling) to project human PK/PD and support first-in-human and proof-of-concept dosing.
Lead exposure–response analyses for efficacy and safety to support dose justification, including oncology dose optimization aligned with current regulatory expectations (e.g., FDA Project Optimus).
Design, oversee, and interpret dedicated clinical pharmacology studies (DDI, food effect, organ impairment, QT/QTc, relative BA/BE as applicable).
Author clinical pharmacology and pharmacometrics components of regulatory documents and responses to health authority queries.
Contribute to MIDD strategy and represent Clinical Pharmacology / Pharmacometrics on cross-functional project teams.
Manage and quality-control deliverables from CROs and external modeling partners.
Required Qualifications
Masters in pharmacology, pharmaceutical sciences, pharmacokinetics, biomedical engineering, or a related quantitative discipline (PhD preferred). 4–6 years of relevant industry experience in clinical pharmacology and/or pharmacometrics. Hands-on population PK/PD modeling with monolix and R. Working knowledge of at least one PBPK platform (Simcyp, GastroPlus, or PK-Sim). Translational pharmacology / preclinical-to-clinical translation (required): demonstrated experience projecting human PK/PD from in vitro and preclinical data, including first-in-human dose selection, IVIVE, and interspecies (allometric) scaling. Working knowledge of MIDD principles. Familiarity with FDA, EMA, and ICH clinical pharmacology guidance, and experience contributing to regulatory submissions. Strong written and verbal communication; able to present quantitative findings to multidisciplinary teams.
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Experience:
Specialized Knowledge: Licenses: Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
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