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- Tasks: Lead innovative projects in preclinical safety and oversee non-clinical research activities.
- Company: Join Novartis, a global leader in reimagining medicine to improve lives.
- Benefits: Enjoy a supportive work environment with opportunities for personal and professional growth.
- Why this job: Be part of a mission-driven team making a real impact on patient lives.
- Qualifications: PhD or equivalent with 7+ years in drug discovery and toxicology expertise required.
- Other info: Join a diverse team committed to collaboration and innovation.
The predicted salary is between 48000 - 72000 £ per year.
Senior Principal Scientist (Study Monitor) – Preclinical Safety
Join to apply for the Senior Principal Scientist (Study Monitor) – Preclinical Safety role at Novartis
Senior Principal Scientist (Study Monitor) – Preclinical Safety
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Join to apply for the Senior Principal Scientist (Study Monitor) – Preclinical Safety role at Novartis
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Summary
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.
Summary
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.
About The Role
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! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewardsSeniority level
- Seniority levelMid-Senior level
Employment type
- Employment typeFull-time
Job function
- Job functionResearch, Analyst, and Information Technology
- IndustriesPharmaceutical Manufacturing
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Senior Principal Scientist (Study Monitor) – Preclinical Safety employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Principal Scientist (Study Monitor) – Preclinical Safety
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those who have experience in preclinical safety and toxicology. Attend relevant conferences or webinars to meet potential colleagues and learn about the latest trends in the field.
✨Tip Number 2
Familiarise yourself with Novartis' recent projects and initiatives in preclinical safety. This knowledge will not only help you understand their goals but also allow you to tailor your discussions during interviews to align with their mission.
✨Tip Number 3
Brush up on your knowledge of GLP regulations and international guidelines related to toxicology studies. Being well-versed in these areas will demonstrate your expertise and commitment to compliance, which is crucial for this role.
✨Tip Number 4
Prepare to discuss your previous experiences in drug discovery and development, particularly any roles where you acted as a Study Director or Monitor. Highlight specific challenges you faced and how you overcame them to showcase your problem-solving skills.
We think you need these skills to ace Senior Principal Scientist (Study Monitor) – Preclinical Safety
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in drug discovery and preclinical safety. Emphasise your expertise in toxicology assays and any previous roles as a Study Director or Study Monitor.
Craft a Compelling Cover Letter: In your cover letter, express your passion for improving patient outcomes through innovative science. Mention specific projects or experiences that align with Novartis' mission and the responsibilities of the role.
Highlight Communication Skills: Since communication is critical for this role, provide examples in your application that demonstrate your ability to liaise effectively with teams and stakeholders. This could include successful collaborations or conflict resolutions.
Showcase Regulatory Knowledge: Mention your familiarity with GLP regulations and international guidelines relevant to toxicology studies. This will show that you understand the compliance aspects crucial for the role at Novartis.
How to prepare for a job interview at Novartis
✨Showcase Your Expertise
As a Senior Principal Scientist, it's crucial to demonstrate your in-depth knowledge of toxicology assays and GLP regulations. Be prepared to discuss specific projects where you've applied this expertise, highlighting your role and the impact of your contributions.
✨Emphasise Communication Skills
Given the importance of communication in this role, practice articulating complex scientific concepts clearly and concisely. Prepare examples of how you've successfully collaborated with cross-functional teams or resolved study-related issues through effective communication.
✨Prepare for Technical Questions
Expect technical questions related to drug discovery and development processes. Brush up on your knowledge of safety pharmacology and genotoxicity, and be ready to discuss how these areas relate to the responsibilities of a Study Monitor.
✨Demonstrate Strategic Thinking
The role requires strategic oversight of study phases and timelines. Be ready to discuss how you've previously established priorities and target dates in your projects, ensuring data-driven advancements and timely reporting.
