Senior Manager, Clinical Pharmacology, Clinical Pharmacology & Pharmacometrics

求人詳細

The Senior Manager / Manager of Clinical Pharmacology in Clinical Pharmacology & Pharmacometrics (CPP) serves as the clinical pharmacology country lead on program, clinical pharmacology, and clinical study teams, providing strategic leadership and expertise in interpretation of clinical pharmacology data for drug candidates. He/she will integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to justify doses, dosage regimens for Japanese taking ethnic differences into consideration throughout clinical drug development.

こんな方を求めています

経験・スキル

・PhD degree in clinical pharmacology, pharmacokinetics, pharmacometrics, statistics, applied mathematics, or a related field. A MSc degree with relevant experience is also acceptable.
・Minimum of 3 years (PhD) or 5 years (MSc) of experience working as a clinical pharmacologist, pharmacokineticist or pharmacometrician within biotech/ pharmaceutical industry.
・Demonstrates an understanding of 1) PK/PD principles, physiology, clinical pharmacology, and pathology; 2) operational and scientific aspects of early development studies; and 3) quantitative analysis.
・Ability to generate development strategies, design clinical pharmacology studies and analyze PK/PD data utilizing sound scientific principles. Ability to relate clinical pharmacology to the broader development paradigm
・Ability to generate electronic data submission package for Japan NDA submission
・Understanding and ability to apply appropriate regulatory and ICH guidelines in the design, analysis, and interpretation of clinical pharmacology studies
・Excellent oral and written communication skills for effective interactions in various environments including, but not limited to multidisciplinary teams, regulatory agencies, scientific symposia, advisory boards
・Knowledge of Health Authority perspective on clinical pharmacology and use of modeling and simulation.

学歴

修士修了以上

募集要項

職種

臨床開発、CRA、CRC

給与

年収 1,000 〜 1,300万円

賞与

-

雇用形態

正社員

雇用期間

期間の定めなし

就業時間

09:00～18:00

休日休暇

土曜日　日曜日　祝日

保険

健康保険　厚生年金保険　雇用保険

受動喫煙防止措置

敷地内禁煙

特長

服装自由, 女性活躍中, 転勤なし, 外資系企業, フレックスタイム制, 年間休日120日以上, 完全週休2日制, 土日祝休み

業種

医療機器・医療品関連

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