Senior Research Scientist - Clinical Operations
- Bangalore, Karnataka
- Permanent
- Full-time
- independently and self-responsible design, organize, monitor, report, and resolve issues for outsourced in vitro and in vivo safety/toxicology studies utilizing external CROs and/or consultants, as applicable. Toxicology and related in-vitro and in-vivo studies include most typical rodent and non-rodent species. Target animal safety may include companion animals (dogs & cats) and food production animals (e.g. cattle, pigs, chickens).
- perform literature searches and author expert reports, position papers, safety and hazard/risk assessments or other strategic scientific / technical / medical assessments to address safety issues for veterinary drugs (small molecules and biologics), feed additives, E&L, excipients, impurities, or other chemicals.
- provide internal expert advice (expert statements, health-based exposure limits e.g. PDE and OEL, target safety assessments, etc.).
- interact with regulatory agencies to address safety concerns with products in development or marketed products, including preparation/submission of documents and formal presentations.
- closely collaborate with Manufacturing, Quality, Human Food Safety, ADME&PK and Environmental Safety colleagues to accomplish multidisciplinary non-clinical objectives for projects and products.
- pro-actively collaborate within global and cross-functional project teams (e.g., clinical, pharmaceutical development, regulatory affairs, quality, manufacturing, etc.) within a matrix organization.
- maintain technical and professional expertise by staying up to date with developments in the field and sharing that information within the company as appropriate.
- a university degree, DVM and/or PhD (preferred) in toxicology or other relevant biomedical science discipline (e.g., veterinary medicine, biology, chemistry) with at least five (5) years of experience in non-clinical safety or equivalent combination of education, training, and relevant experience or master’s degree with at least seven (7) years of experience.
- the ability to apply toxicological and/or risk assessment principles in accordance with relevant regulations, guidance and/or models.
- a Board Certification as toxicologist (ERT, DABT or equivalent), preferred.
- an immunological background is preferred to cover safety questions for new platform approaches (e.g. monoclonal antibodies) especially in therapeutic indications, like dermatology or pain.
- a working understanding of US, European and international veterinary drug/product development and various agribusiness practices affecting companion and farm animals.
- understanding of non-clinical veterinary drug development process (from safety target assessment, early in silico predictions, target, user and consumer safety assessment and further life cycle management).
- sound expertise in the development of large molecules, biologics, vaccines, and antibodies.
- experience using in vitro and in vivo data and published data/literature to support drug and/or product development, registration and/or defense.
- strong verbal and written communication skills are crucial for success in this position.
- excellent language skills in English.
- the ability to work independently and self-manage assigned workload including diverse deliverables and timelines with competing priorities.
- working knowledge of the Good Laboratory Practice (GLP) regulations.
- proficiency with standard computer software applications for general office work (word processing, presentation, and spreadsheet) and experience in using in silico toxicity prediction tools.
eQuest