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About the Role
This role supports the clinical team by responding to inquiries regarding nonclinical studies and developing toxicology and safety pharmacology strategies for Japan's clinical development plan. It involves discussions on supplemental studies, information gathering on regulatory topics and competitor activities, and providing nonclinical data for regulatory submissions.
Responsibilities
- Support the clinical team by responding to inquiries on nonclinical studies for investigator meetings.
- Develop toxicology and safety pharmacology strategies for Japan's clinical development plan (Phase 0-2).
- Discuss supplemental studies with global counterparts and colleagues based on Japan and Northeast Asian regulatory requirements.
- Collect and analyze information on regulatory topics and competitor development in Japan and Northeast Asian countries, sharing with global CPS and relevant members.
- Respond to PMDA inquiries and objections on pharmacology and preclinical safety matters in Japanese, in collaboration with global counterparts.
- Prepare the nonclinical sections (pharmacology, toxicology, safety pharmacology) of investigator brochures in Japanese.
- Provide non-clinical components for regulatory dossiers and CTD, specifically general & safety pharmacology, toxicology, and pharmacology for J-NDA and Northeast Asian countries, in partnership with global CPS.
- Undertake assigned global roles or tasks from global CPS, participating in CPS-Japan and CPS PRM TC meetings to share information.
- Collaborate on global business development for new licensing-in compounds concerning toxicology and safety pharmacology.
- Gather information on basic medicine by attending annual meetings of academic societies and pharmaceutical industry associations.
- Provide fundamental product knowledge to clinical, medical affairs, and commercial divisions.
Requirements
- Experience in developing toxicology and safety pharmacology strategies.
- Familiarity with Japan and Northeast Asian regulatory requirements.
- Experience in preparing nonclinical sections of regulatory dossiers and investigator brochures.
- Ability to communicate effectively in Japanese for regulatory interactions.
- Experience in collaborating with global teams.
- Knowledge of basic medicine and pharmaceutical industry trends.
Skills
- Toxicology
- Safety Pharmacology
- Regulatory Affairs
- Clinical Development
- Pharmacology
- Data Analysis
- Communication (Japanese)
- Business Development
- Information Gathering