As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
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 for all phases of global veterinary pharmaceutical drug/product and feed additive research and development and will provide support for marketed products.
Your tasks
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Independent 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 (cattle, pigs, chickens, sheep, goats, fish).
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Perform literature searches and author expert reports, position papers, safety and 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.
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Providing internal expert advice (expert statements, health-based exposure limits e.g. PDE and OEL, target and product safety assessments, etc.)
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Interact with regulatory agencies to address safety concerns with products in development or marketed products, including preparation/submission of documents and formal presentations.
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Prepare human and target animal safety sections of product registration dossiers and product labels for submission to European, US and international regulatory agencies.
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Closely collaborate with Human Food Safety, ADME&PK and Environmental Safety colleagues to accomplish multidisciplinary non-clinical objectives for projects and products.
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Pro-actively collaborate within global and cross-functional project teams (e.g., clinical, pharmaceutical development, regulatory affairs, quality, manufacturing, etc.) within a matrix organization.
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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
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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.
- Ability to apply toxicological and/or risk assessment principles in accordance with relevant regulations, guidance and/or models.
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Board certification as toxicologist (ERT, DABT or equivalent), preferred.
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A working understanding of European and international veterinary drug/product development and various agribusiness practices affecting companion and production animals, including aquaculture.
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Excellent 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).
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Sound expertise in the development of large molecules, biologics, vaccines, and antibodies.
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Proficiency at placing, designing, monitoring, and reporting in vivo studies (e.g., toxicology, safety) at CROs.
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Experience using in vitro and in vivo data and published data/literature to support drug and/or product development, registration and/or defense.
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Proven experience and knowledge in pharmaceutical drug development and with global regulatory submissions for companion and food animal drugs.
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Experience successfully authoring risk assessments / expert reports / scientific position papers for a non-expert audience.
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Working knowledge of the Good Laboratory Practice (GLP) regulations.
Additional Skills
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Strong verbal and written communication skills are crucial for success in this position.
- Excellent language skills in English.
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You are a team-player with excellent inter-personal skills and experience collaborating in a diverse global cross-functional team environment.
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Ability to work independently and self-manage assigned workload including diverse deliverables and timelines with competing priorities.
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Proficiency with standard computer software applications for general office work (word processing, presentation, and spreadsheet) and experience in using in silico toxicity prediction tools.
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