メディカル・バイオ - 前臨床（薬効薬理・毒性・ADME）

- Assess preclinical toxicology data to ensure the safety of volunteers and patients participating in clinical trials in Japan.
- Ensure the adequacy, scientific quality, and regulatory compliance of the toxicology data package required to advance products through their development stages in Japan.
- Identify critical toxicological findings and propose appropriate mitigation strategies or risk-reduction measures.
- Prepare high-quality toxicology documentation needed for initiating clinical trials, conducting PMDA consultations, and submitting NDAs.
- Respond to internal and external toxicology-related inquiries, including questions from regulatory authorities, in close collaboration with global teams.
- Evaluate potential drug candidates from a toxicology and regulatory perspective as part of due diligence activities.
- Actively contribute to global Preclinical Development (PCD) initiatives and cross-functional projects as a member of the global PCD organization.
- Mentor and develop junior staff, helping them build strong toxicology expertise.

■休日：完全週休二日制, 土, 日, 祝日, 夏季休暇, 年末年始

※下記はスタッフ職での要件です※
-A minimum of 3-year experience in regulatory toxicology (e.g. dossier preparation, human safety assessment or related) OR in experimental toxicology as a laboratory staff or a study monitor.
-Understanding of related regulations/guidelines and GLP-Experience involved in drug development in pharmaceutical industry (more than 5 years)
-Experience involved in the regulatory submission as a representative of preclinical (more than 2 products is preferred).
-Other general skills and competencies include logical thinking skill, problem solving skill

■職種未経験者：不可