Senior Principal Scientist (Study Monitor) - Preclinical Safety

Job Description Summary

The Preclinical Safety (PCS) department within the Biomedical Research (BR) - Translational Medicine Unit provides non-clinical safety strategies for products in discovery, development, and market, globally, with state-of-the-art regulatory compliance.

As a Scientific Study Monitor, you will join our PCS team to oversee non-clinical research activities across multiple projects and disease areas, focusing on in-vivo toxicity and/or in-vitro screening toxicity studies conducted at our CRO partner sites. You will act as the primary scientific contact for the Study Director.

Job Responsibilities

1. Lead or co-lead novel projects, facilitating collaboration to achieve impactful results aligned with BR goals. Generate innovative ideas to meet new technical requirements and address key scientific questions.
2. Serve as the appointed Study Monitor for outsourced preclinical studies, based on expertise and scientific background, acting as the primary contact for the Study Director at CROs.
3. Oversee study progress, ensuring conduct, recording, and reporting comply with the protocol, GLP regulations, animal welfare policies, and international guidelines.
4. Resolve study-related issues, liaise with internal experts, and ensure timely communication and report delivery.
5. Develop strong working relationships with team members through effective communication.
6. Collaborate with PCS-Operations and PTM to formulate outsourcing strategies.
7. Maintain knowledge of HA regulations (Swiss medic, OECD, FDA) to support GLP toxicology studies.
8. Potentially serve as a part-time PCS PTM.

Role Requirements

• PhD or MVSc/MS/M.Pharm with 7+ years of experience in drug discovery or development, preferably as Study Director or Study Monitor in early preclinical and GLP studies.
• Deep knowledge of toxicology assays, safety pharmacology, and genotoxicity.
• Proficiency with techniques and tools used in drug design and development.
• Excellent communication skills, strong teamwork, and logistical planning abilities.
• Registration and certification with an International Toxicology register.

Why Novartis: Our purpose is to reimagine medicine to improve and extend lives. Join us to be part of this mission. Learn more:

Commitment to Diversity and Inclusion: We strive to build an inclusive, diverse work environment reflecting the communities we serve.

Connect with Us: Join the Novartis Network to stay informed about career opportunities:

Help us create breakthroughs that change patients' lives. Join our community of passionate professionals.

Benefits and Rewards: Discover how we support your personal and professional growth:

Skills Desired: Animal Models, Bioinformatics, Chemistry, Clinical Research, Collaboration, Communication, Data Analysis, Drug Development, Drug Discovery, Ethics, Flexibility, Influencing Skills, Laboratory, Lifesciences, Medical Research, Patient Care, Pharmaceutics, Problem Solving, Regulatory Compliance, and more.