非臨床開発担当/ Preclinical Development Associate

A global pharmaceutical company is seeking a Preclinical Development Associate. The selected applicant will be leading all aspects of preclinical trials for nucleic acid drugs targeting CNS diseases.

Responsibilities:

• Plan and develop protocols for preclinical trials focused on nucleic acid drugs targeting CNS diseases.
• Select, negotiate with, and manage Contract Research Organizations (CROs) for study execution.
• Oversee trial progress, monitor data quality, and ensure timely completion of studies.
• Evaluate preclinical study results and prepare comprehensive scientific reports.
• Communicate and coordinate with regulatory authorities (e.g., PMDA) on trial matters.
• Collaborate cross-functionally with Research, Clinical Development, and CMC teams.
• Stay current with the latest developments and regulatory trends in preclinical research.
• Ensure all studies comply with relevant regulatory and ethical standards.

Requirements:

• Master's degree or higher in Pharmacy, Agriculture, or Science
• More than 3 years of preclinical development experience in a pharmaceutical or biotech company
• Experience working with middle molecule drugs (oligonucleotides, peptides, etc.)
• Knowledge of BROTHERS nucleic acids and experience in CNS area development are welcome
• Proficient in reading and writing in English is a plus

About the Company:

A leading pharmaceutical company specialising in innovative drug development and cutting-edge research. Renowned for its global impact, the company is dedicated to advancing healthcare through scientific excellence.

Keywords:

製薬, バイオテクノロジー, ヘルスケア, 外資系

創薬ベンチャー企業にて、非臨床開発担当の募集です。

職務内容:

• 試験計画の立案・作成
• 試験委託先の選定・管理・折衝
• 試験の進捗管理、データモニタリング
• 試験結果の評価、報告書作成
• 規制当局との相談・対応
• 開発本部内関連部署（研究、臨床開発、CMCなど）の連携
• 非臨床試験に関連する最新情報の収集と知識のアップデート

応募要件:

• 大卒（薬学、農学、理学系）
• 製薬企業またはバイオテック企業における非臨床開発経験3年以上
• 中分子医薬品（オリゴヌクレオチド、ペプチド等）に関する業務経験
• BROTHERS核酸に関する知識歓迎
• CNS領域の開発経験歓迎

会社概要:

革新的な医薬品の研究、開発、製造に取り組むリーディングカンパニー。専門分野は多岐にわたり、最先端の技術と厳格な品質管理を駆使して、安全で効果的な医薬品を市場に提供しています。今後もさらなる研究開発を進め、医療の未来をリードしていきます。

Job Ref: 3T1L96