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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.
- 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).
- 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.
- Providing internal expert advice (expert statements, health-based exposure limits e.g. PDE and OEL, target and product 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.
- Prepare human and target animal safety sections of product registration dossiers and product labels for submission to European, US and international regulatory agencies.
- Closely collaborate with 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.
- PhD 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.
- Board certification as toxicologist (ERT, DABT or equivalent), preferred.
- A working understanding of European and international veterinary drug/product development and various agribusiness practices affecting companion and production animals, including aquaculture.
- 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).
- Sound expertise in the development of large molecules, biologics, vaccines, and antibodies.
- Proficiency at placing, designing, monitoring, and reporting in vivo studies (e.g., toxicology, safety) at CROs.
- Experience using in vitro and in vivo data and published data/literature to support drug and/or product development, registration and/or defense.
- Proven experience and knowledge in pharmaceutical drug development and with global regulatory submissions for companion and food animal drugs.
- Experience successfully authoring risk assessments / expert reports / scientific position papers for a non-expert audience.
- Working knowledge of the Good Laboratory Practice (GLP) regulations.
- Strong verbal and written communication skills are crucial for success in this position.
- Excellent language skills in English.
- You are a team-player with excellent inter-personal skills and experience collaborating in a diverse global cross-functional team environment.
- Ability to work independently and self-manage assigned workload including diverse deliverables and timelines with competing priorities.
- Proficiency with standard computer software applications for general office work (word processing, presentation, and spreadsheet) and experience in using in silico toxicity prediction tools.
Notification of Drug testing and Background Checks
Elanco conducts urinalysis drug testing as a mandatory part of its pre-employment application and background check process after acceptance of a conditional offer of employment by an applicant. The drug testing will be conducted by a certified laboratory/testing service selected by Elanco, in accordance with the procedures required by applicable state and federal law. Additionally, Elanco requires successful completion of a urinalysis drug test if it has reasonable suspicion that an employee is under the influence of drugs or alcohol which adversely affects or could adversely affect the employee's job performance as allowed by applicable law. Tested applicants will be given a copy of any positive test result. All test results shall be considered confidential and shall not be disclosed by Elanco, other than to those persons for whom such disclosure is necessary. Positive test results, or a refusal to consent to and participate in pre-employment drug testing, shall be grounds for denial of employment. Cooperation in scheduling the testing is important for processing an application for employment. By signing your acceptance to an offer of employment, you consent to be drug tested and acknowledge you have thoroughly read the foregoing notice and policy, and you understand and agree that in order to be considered for employment with Elanco, you will be required to comply with Elanco's drug testing policy. Elanco's background check requirements also include but are not limited to an acceptable criminal background check, educational verification, job history verification and motor vehicle report (if required to drive a company vehicle). If appropriate for the role, as outlined on the job posting, successful completion of Post Offer Exam, Work Simulation and/or Administrative Skills Testing may also be required.
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