Senior Research Scientist - Clinical Operations

Research Scientist – Toxicology – Global Non-Clinical Development

We are seeking an experienced non-clinical toxicology/safety scientist to join the Global Non-Clinical Development team in Global Clinical Development. This position will be responsible for, or will assist with, human (user & consumer) safety and target animal safety program strategy and execution at all phases of global veterinary pharmaceutical drug/product and feed additive research and development, product safety assessments, and support for marketed products.

Your tasks include: evaluating a broad range of issues ranging from development activities to commercial support. Written assessments of the potential safety issues associated with product performance through product or process design, a deviation, a consumer complaint, or a planned development or commercial/manufacturing change that potentially impacts the safety or safe use of the product and which may adversely affect animal safety, as well as consumer or end-user health. This includes the preparation of Product Safety Assessments (PSA) in the process of being manufactured, already manufactured, or marketed, during all stages of the life cycle of a product. Compile medical and/or toxicological data for an assessment to determine the potential health risk(s) for consumers or end users.

You will:

• 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.
• 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.

Your profile includes:

• 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.

And you are a team-player with excellent inter-personal skills and experience collaborating in a diverse global cross-functional team environment.

Further, domestic and some international travel requirements are approx. up to 30%. Office: IAC Bengaluru, India (flexible working policy). Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.