Senior Scientist – Scientific Study monitoring – Preclinical Safety

Key Responsibilities:

• Develop study protocols and study designs in collaboration with CRO study directors and internal SMEs for genotoxicity, phototoxicity, immunotoxicity, cardiotoxicity (ion channel) assays and in-vivo rodent toxicity studies.
• Review study protocols, study data and study reports for different toxicity studies.
• Ensuring that the study is conducted, recorded, and reported according to the study protocol.
• Ensure data quality and presentation for internal and external use.  
• Coordinating research activities with functional groups across the organization to ensure performance, timeliness, and integrity of data generated by CRO partners.
• Resolution of study related issues, liaisons with internal experts, and communicating with appropriate people in a timely manner is pivotal to the performance of this role.
• Tracking and ensuring timely achievement of key milestones in every study of every program at the CRO will be an important KPI for this role including tracking study phases, sample transfer, etc.  
• The Study Monitor should ensure that the study is compliant with Novartis animal welfare policies, CRO in-house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines/regulations.
• Work closely with the Preclinical safety Project Team Members (PTM), and/or scientific champion/principal investigator to execute a study or project outsourcing plans.

Essential Requirements:

• PhD or MVSc/MS/M.Pharm in life sciences with 4+ 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

Desirable Requirement:

• Animal Models.
• Collaboration.
• Communication Skills.
• Data Analysis.
• Ethics.
• Laboratory.
• Problem Solving.
• Regulatory Compliance.
• Research.
• Risk Assessment.
• Toxicology.

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

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

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.