Senior Research Scientist - Clinical Operations

At Elanco (NYSE: ELAN) - it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of Food and Companionship Enriching Life and our approach to sustainability - the Elanco Healthy Purpose - to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals lives better makes life better - join our team today!

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

This role utilizes toxicology and immunology expertise and experience to evaluate 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. 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.

Your profile

You have ...

• 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 and 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 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 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