Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Senior Scientist – Scientific Study monitoring – Preclinical Safety
Summary
The Preclinical Safety (PCS) department within the Novartis Biomedical Research - 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 in India to oversee non-clinical research activities for multiple projects across multiple disease areas for in-vitro screening and in-vivo rodent toxicity conducted at our CRO partner sites as per the internal strategy and international standards, acting as the primary scientific contact for the Study Director.
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.
Candidate Profile
• 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
Additional Information
Qualification & Experience : PhD or MVSc/MS/M.Pharm in life sciences with 4+ years of experiences
Location : Hyderabad
Job ID : REQ-10005864
End Date : 20th June 2024
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