Senior Principal Scientist Full-time

Pharmacokinetic Expert

As a PK Expert, contribute to Novartis' pharmaceutical development in Japan as a member of departmental or cross-departmental project teams or other science or business/operations teams. Analyze data obtained in all stages of projects and present results in a clear and concise manner.

Main Roles and Responsibilities

• Contribute to Japanese development as a key member of the project team.
• Create internal decision-making conference materials, clinical trial protocols, clinical summary reports, investigational drug summaries, new drug approval documents, and other documents in compliance with all regulatory requirements and within deadlines.
• Share and support or lead in resolving PK-related issues in projects under development in Japan through communication with Global.
• Align PK plans and strategies with sub-teams, project teams, and leadership teams.
• Participate or lead in cross-departmental teams and department-wide initiatives.

Follow the company's schedule to complete all necessary organizational training and requirements. Adhere strictly to appropriate SOPs.

Required Qualifications

• Master's or doctoral degree in a scientific field (PhD).
• Five or more years of experience in the clinical pharmacology department related to drug metabolism and pharmacokinetics.
• Experience in a leadership position in an organization or team.
• Experience in clinical trial development and new drug approval applications.
• Knowledge of related fields in drug discovery or development (e.g., biostatistics, toxicology, regulation).
• Fluent in Japanese and English (both oral and written).
• Leadership and communication skills.
• Flexible consideration of required qualifications.

Desired Qualifications

• Experience working in a research institute.
• Experience using PK-related software (Phoenix, NONMEM, SAS, GastroPlus, etc.).
• Knowledge and experience with radiopharmaceuticals.
• Experience with modeling analysis (PPK, PKPD, PBPK, etc.).

Information about Novartis' benefits and rewards can be found in the Novartis Life Handbook.

Novartis is committed to building an inclusive and diverse workplace that provides a comprehensive and rewarding work environment for all employees.

Novartis is committed to providing reasonable accommodations to individuals with disabilities and will collaborate to meet your needs.

If you require reasonable accommodation to complete the application process, or if you are currently employed at Novartis, please email midcareer-r.japan@novartis.com with your request, including your name, contact information, and the job posting number.

Skills Desired: Chemistry, Clinical Pharmacology, Clinical Research, Clinical Study Reports, Clinical Trial Development, Clinical Trials, DMPK, Drug Discovery, Due Diligence, Gene Therapy, Medical Development, Medical Research, Microsoft Office, Modeling And Simulation, NONMEM, Pharmaceutical Products, Translational Medicine