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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.
The Global Clinical Development – FA Research Scientist is responsible for the strategy, design, and conduct of clinical effectiveness and safety programs for global FA development projects. The role has the following core responsibilities within global food animal therapeutics, nutritional, parasitology, and biopharma clinical development:
- Ensure the collection of accurate and complete datasets of safety and efficacy studies in compliance with the required global regulatory standards and guidelines.
- Contribute as a clinical subject matter expert (SME) to and/or lead clinical project teams for the development and licensure of global food animal therapeutic projects.
- Contribute as a clinical SME to and/or lead product line extension and/or product remediation projects.
This role necessitates developing and maintaining strong relationships with functional partners in manufacturing, regulatory affairs, quality, commercial and other areas of research and development (R&D).
- Provide creative and proactive solutions to project teams
- Work with the project team to proactively develop and communicate in a timely manner to management the overall project strategy, budgets, phase transitions, project progress and any delays, key issues, and any other critical topics. Represent the project team at scientific review and portfolio management boards.
- Actively participate in internal and external communication with other scientists to ensure excellence in study design and execution
- Constantly improve knowledge and expertise in state of the art for farm animal clinical trial and target animal safety design and model system development
- Design, implement, and oversee appropriate clinical efficacy and / or safety studies
- Development and validation of models for disease states of interest
- Assist in drafting regulatory submissions and participate during dossier review process
- Direct involvement in discussions with global regulatory authorities in planning and implementation of development programs
- Complete study documentation in accordance with appropriate quality standards
- Provide information to ensure accurate tracking of project budgets and timelines
- Ensure scientific integrity and animal welfare in all activities
- Attend scientific meetings, continuing education courses and keep abreast of scientific advances and new developments in the animal health industry.
- PhD in animal science, pharmacology, or other biomedical field or MS in animal sciences, biomedical or related scientific field with appropriate related experiences (>10 years) which could include academic research with a record of publication
- DVM with MS or PhD in animal science, pharmacology, or other biomedical field OR
- DVM with farm animal experience in regulated studies
- Familiar with GCP / GLP study documentation and execution
- Preference given to DVM with technical expertise in target animal safety
- Advanced understanding of research and development processes
- Excellent communication and interpersonal skills
- Demonstrated ability to lead effectively cross-functional processes
- Acting as strategist and facilitator to drive clinical programs
- Proven experience working with regulatory authorities
- Good understanding and working knowledge of GCP/GLP/GMP and quality
- Demonstrated ability to collaborate with external partners
- Some travel required (domestic and international)
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