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For Companies At a Glance
- Tasks: Lead innovative preclinical safety studies and ensure compliance with regulations.
- Company: Join Novartis, a leader in reimagining medicine for better lives.
- Benefits: Enjoy personal growth opportunities, diverse work culture, and competitive rewards.
- Why this job: Make a real impact in drug development while collaborating with passionate professionals.
- Qualifications: PhD or equivalent with 7+ years in drug discovery and strong toxicology knowledge.
- Other info: Be part of a diverse team committed to improving patient lives globally.
The predicted salary is between 54000 - 84000 £ per year.
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
- 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.
- 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.
- Oversee study progress, ensuring conduct, recording, and reporting comply with the protocol, GLP regulations, animal welfare policies, and international guidelines.
- Resolve study-related issues, liaise with internal experts, and ensure timely communication and report delivery.
- Develop strong working relationships with team members through effective communication.
- Collaborate with PCS-Operations and PTM to formulate outsourcing strategies.
- Maintain knowledge of HA regulations (Swiss medic, OECD, FDA) to support GLP toxicology studies.
- 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: https://www.novartis.com/about/strategy/people-and-culture
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: https://talentnetwork.novartis.com/network
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: https://www.novartis.com/careers/benefits-rewards
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.
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Senior Principal Scientist (Study Monitor) – Preclinical Safety employer: Healthcare Businesswomen's Association
Contact Detail:
Healthcare Businesswomen's Association Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Principal Scientist (Study Monitor) – Preclinical Safety
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines related to GLP toxicology studies. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and safety in preclinical research.
✨Tip Number 2
Network with professionals in the field of toxicology and preclinical research. Attend relevant conferences or webinars, and engage with experts on platforms like LinkedIn to build connections that could lead to job opportunities.
✨Tip Number 3
Showcase your leadership skills by discussing any past experiences where you led projects or collaborated with cross-functional teams. Highlighting these experiences can set you apart as a candidate who can drive impactful results.
✨Tip Number 4
Prepare to discuss specific toxicology assays and methodologies you have worked with. Being able to articulate your hands-on experience with these techniques will demonstrate your technical expertise and suitability for the role.
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 development, particularly as a Study Director or Study Monitor. Emphasise your knowledge of toxicology assays and GLP studies.
Craft a Compelling Cover Letter: In your cover letter, express your passion for improving patient lives through innovative research. Mention specific projects or experiences that align with the role's responsibilities and demonstrate your leadership skills.
Highlight Communication Skills: Given the importance of collaboration in this role, provide examples of how you've effectively communicated and worked with teams in previous positions. This could include resolving study-related issues or liaising with experts.
Showcase Regulatory Knowledge: Mention your familiarity with HA regulations such as Swiss medic, OECD, and FDA guidelines. This will demonstrate your preparedness to oversee compliance in preclinical studies.
How to prepare for a job interview at Healthcare Businesswomen's Association
✨Showcase Your Expertise
Make sure to highlight your extensive experience in drug discovery and development, particularly as a Study Director or Study Monitor. Be prepared to discuss specific projects you've led and the impact they had on preclinical safety.
✨Demonstrate Knowledge of Regulations
Familiarise yourself with relevant regulations such as GLP, OECD, and FDA guidelines. During the interview, be ready to explain how you have ensured compliance in past studies and how you would approach this in the new role.
✨Emphasise Communication Skills
As a Study Monitor, effective communication is key. Prepare examples of how you've successfully collaborated with teams and resolved study-related issues, showcasing your ability to maintain strong working relationships.
✨Prepare for Technical Questions
Expect to be asked about toxicology assays and safety pharmacology. Brush up on the latest techniques and tools used in drug design and development, and be ready to discuss how you've applied these in your previous roles.
