Mar 27, 2022

Job Description

9.4 billion spend on Research and Development. That commitment resulted in 24 major regulatory approvals in 2019 in the US, EU, Japan and China.

Major Responsibilities:
1. Represents PK Sciences as a core member of project teams in Japan.
2. Participates or leads PKS sub-team to define PKS strategy for compound progression and development.
3. Works with manager to effectively communicate data, strategy and results to the project teams.
4. Aligns plans and strategies with sub-teams, project teams, manager and leadership team.
5. Analyze and interpret PK/TK/PD/IG data generated during discovery, early and/or full development; present results to the program.
6. Works with team under management supervision to identify potential project hurdles.
7. Contributes to internal transition documents, clinical study protocols, clinical study reports, investigator brochures, CTNs and NDAs within agreed timelines, and meeting all regulatory requirements.
8. Participates in cross-departmental teams, department-wide initiatives and work streams.
9. Completes all required organizational trainings and requirements according to corporate timelines.
10. Adhere in strict accord to the appropriate SOP and GxP guidelines.
11. Ensures adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
12. 100% timely delivery of all training requirements including compliance.

Technical Responsibilities:
• Proficiency with key software (e.g. Phoenix)
• PK/TK study design expertise
• Regulatory knowledge of area of CP & Biopharmaceuticals
• Clinical study design • Regulatory guidance • CP strategy, discovery characterization

Why consider Novartis?
817million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

PhD / Pharm.D. level scientist with relevant experience in drug metabolism and pharmacokinetics or related biologic back ground.

Fluent Japanese (oral and written) Fluent English (oral and written)

4+ years in the pharmaceutical industry

Professional Requirements:
1. 4+ years of experience in drug discovery, development or a relevant environment (e.g. Drug Metabolism and Pharmacokinetics).
2. Experience working in a drug discovery or development or relevant experience in a CRO, Pharma or Biotech.
3. Knowledge of related disciplines (e.g., biostatistics, toxicology, regulatory) in the drug discovery or development process.
4. Demonstrated success in working cross functional team in a highly dynamic, matrixed, project-team environment.
5. Strong organizational and project skills with critical thinking and problem solving skills.
6. Strong oral and written communication skills.

· Pharmacology / Toxicology / Pharmacokinetics / Drug Metabolism /Analytical chemistry / Immunology
· Biopharmaceutics or similar discipline
· Regulations & Guidelines
· Chemistry
Translational Medicine
Research & Development
Full Time
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Principal Scientist, Translational Medicine Japan

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