Senior Principal Scientist (Study Monitor) – Preclinical Safety Full-time

Preclinical Safety Scientific Study Monitor

The Preclinical Safety (PCS) department within the Biomedical Research (BR) – Translational Medicine Unit provides non-clinical safety strategy of 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 for multiple projects across multiple disease areas for in-vivo toxicity and/or in-vitro screening toxicity studies conducted at our CRO partner sites as per the internal strategy and international standards, acting as the primary scientific contact for the Study Director.

Major accountabilities:

• Formulates and leads/co-leads novel projects with team or enables matrix collaboration on project/technology solutions to achieve creative results for impact on BR goals. Generates innovative ideas within own team and/or project team/functional community to meet new technical requirements and/or answer project key scientific/technical/development questions. Establishes target dates and priorities to enable data-driven advancements in project teams, within own team, and with collaborators, or within functional community.
• The Study Monitor is appointed to each outsourced preclinical study based on relevant technical expertise, designated disease area and/or scientific background knowledge and acts as the primary scientific contact for the Study Director at the Contract Research Organization (CRO).
• The Study Monitor is responsible for overseeing the progress of the study and for ensuring that the study is conducted, recorded and reported according to the study protocol. The Study Monitor should ensure that the study is compliant with the appropriate GLP regulations, Novartis animal welfare policies, CRO in-house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines/regulations.
• Resolution of study related issues, liaisons with internal experts and informing the appropriate people in a timely manner is pivotal to the performance of this role. The study phases and sample delivery timelines should be strategically overviewed and tracked to ensure that internal contributor reports are delivered to the CRO on time and that the CRO meets its agreed main reporting timelines.
• Communication skill is critical to this role in forming strong working relationship with other Target team members.
• Works closely with the PCS-Operations and PCS Project Team Member (PTM) to formulate a project outsourcing strategy.
• Has a working knowledge of HA regulations (Swiss medic, OECD, FDA) to support conduct of GLP compliant toxicology studies.
• May be PCS part-time PTM

Role Requirements:

• PhD or MVSc/MS/M.Pharm with 7+ years of experiences in drug discovery and/or development, preferably as Study Director or Study Monitor in the early preclinical screening and GLP studies
• In-depth knowledge of toxicology assays in early development, Safety pharmacology and genotoxicity
• Proficient with full range of techniques used in job and core areas. Working knowledge of tools and processes used in drug design and development.
• Excellent communicators, strong team players and have a high level of logistical/planning ability.
• Registration and certification with one of the International Toxicology registers.

Why Novartis:

Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!

Commitment to Diversity and Inclusion:

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

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Skills Desired:

• Animal Models
• Apache Continuum
• Bioinformatics
• Chemistry
• Clinical Research
• Collaboration
• Communication Skills
• Data Analysis
• Drug Development
• Drug Discovery
• Due Diligence
• Ethics
• Flexibility
• Influencing Skills
• Job Description
• Laboratory
• Lifesciences
• Line Of Business
• Medical Research
• Patient Care
• Pharmaceutics
• Problem Solving
• Regulatory Compliance