[DJ] Manager, Assay Coordinator/アッセイ・コーディネーター - Pfizer : Job Details

1. Objectives:In order to obtain high-quality pharmacokinetic (PK)/biomarker/antibody/pharmacogenomics (PGx) data from a clinical study, take charge of series of work concerning PK/biomarker/ antibody/PGx assay and oversight assay sites in order to execute these duties.In addition to the above, Manager trains and educates assay coordinators and establish good collaboration with global partners.2. Roles and Responsibilities:[Duties concerning each protocol conduction (Phase I-III clinical studies)]PK/biomarker/anti-drug antibody (ADA):Assist protocol preparation (PK/biomarker/ADA assay) providing information Confirm adequacy of assay sites selection and analysis methods and negotiate with overseas concerning Conduct assay method validation as appropriate Obtain a cost estimate from, contract with, and pay to assay sites Oversight assay sites and manage assay schedule Provide/confirm sample collection and handling procedures of PK/biomarker/ADA samples Prepare and confirm sample shipment and set up preparation of sample labels. Discuss with a central laboratory concerning sample collection and handling procedures and materials Confirm scientific validity of data and request re-assay Manage data of results concerning PK/biomarker/ADA assay Confirm bioanalysis plan and bioanalysis report Assist Clinical Study Report preparations Request disposal of samples[NDA-related duties and the others]Conduct assay-related work in J-NDA (CTD preparation, document compliance review, GCP inspection, and responding to the queries) Provide information and advice related to PK sample handling, assay methods and assay sites to Phase IV stage and investigator-initiated clinical trials Obtain required knowledge through participating in domestic and overseas related-academic conferences and communicating with experts and expand it to work Improve/standardize domestic and overseas work processesFor Manager, the followings are to be added to the aboveDevelop the plan and propose it for building structure to contribute to domestic and global development Have a good communication with Global Clinical Bioanalytics for developing the working structure Establish system for introducing the global processes Prepare and propose a preliminary draft for appropriate allocation of resources Prepare the training plans for Assay Coordinators and provide direction Ensure the quality and manage the progress of Assay Coordinator tasks3. Skills, Behavior Requirements:・ Knowledge/understanding skill of PK, pharmacodynamics and analysis methods・ Understanding skill in GCP, related guidelines and SOPs, and announcement from the authorities・ Accurate performance in every study process・ Well-balanced, good negotiation skill・ Having foresight, judgment and problem solution skill・ Ability to grasp problem precisely and solve it in right timing・ Communication and negotiation skills with overseas (English skill)For Manager, the followings are to be added to the above・ Personal management skill e.g. appropriate allocation of resources and schedule management・ Human resources development skillWork Location Assignment: HybridPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Medical#LI-PFE