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tkim@hikma.com

Description

Manages standard and complex in vitro and in vivo studies to support new and ongoing multisource products independently.

The scope of the studies includes various in vitro studies including developmental work, dissolution studies for Extended Release products, and additional in vitro studies required for nasal and inhalation studies. The scope of the in vivo studies includes single dose and multiple dose studies in healthy subjects and patients model. These studies may be conducted both in the U.S. and internationally. 

The CRM works with the PDT to schedule, implement, and complete all required in vitro and in vivo studies needed to support 14 to 18 ANDA filings. Knowledge on pharmacokinetics/pharmacodynamics and hands-on experience are required to predict rate of success by statistical prediction and diverse simulation.

Why: To ensure completion of required studies to support regulatory filing.

How: Obtains competitive bids from CROs with expertise in study requirements, selects CRO, develops or works with CRO/consultants to develop study protocol and other study related documents, ensures all elements are in place for study to run successfully.

Responsible for determining regulatory requirements for international studies and relaying required information to relevant departments to meet submission requirements. 

Ensures studies comply with all requirements, such as WIs, SOPs, and GCP’s. Leads critical review of all study related documents.

Ensures the appropriateness of the study design based on pharmacokinetic and/or clinical knowledge of the drug product, and all regulatory requirements.

Demonstrates leadership skills in the management of studies to independently direct all study related activities to ensure it is conducted to meet timeline requirements.

Requirement

Bachelor’s Degree in pharmaceutical or related sciences with a minimum of 6 years’ relevant experience in conducting clinical studies; or Master’s degree in pharmaceutical or related sciences with a minimum of 4 years’ relevant experience in conducting clinical studies; or PhD or equivalent in pharmaceutical or related sciences with minimum of 1 year of relevant experience in conducting clinical studies. Knowledge of phase I through phase IV development is required. Experience in conducting studies for development of generic products is strongly preferred. Fundamental knowledge of pharmacokinetics/pharmacodynamics and hands-on experience are strongly preferred.