The Safety Research Scientist contributes to the development of new animal health products by providing strategic and scientific expertise for Safety programs that will meet global regulatory requirements, and provide an innovative approach to achieving Elanco R&D objectives. The purpose of this position is to manage the outsourcing of safety studies (target animal safety, toxicology and environmental safety) to Contract Research Organizations (CROs). As part of a Development Team, this position takes responsibility for the assessment and selection of CROs and for the design, outsourcing, conduct and completion of safety studies as well as for data assessment and interpretation. This role interacts with regulatory agencies globally and leads the effort to build the global safety dossier.
Key Leadership Responsibilities
Work effectively and flexibly within and across all Elanco R&D teams and external collaborators to achieve overall Elanco R&D deliverables.
Create a positive work environment that is aligned with company objectives.
Create an engaging culture with a "Play to Win" mentality.
Provide and accept challenge to deliver innovative technical solutions and create an innovative culture. Proactively search for solutions.
Identify and utilize methods to deliver individual objectives in a high quality, timely, cost-effective manner.
Provide information to facilitate accurate and timely project and budget forecasts.
Manage project timeline and budget deliverables to facilitate delivery of the Elanco pipeline.
Coach/support other colleagues for optimal project progress. Ensure efficient and open communication, and take lead to resolve conflicts.
Key Technical Responsibilities
Assume overall responsibility and accountability for the Safety programs (target animal safety, toxicology and environmental safety) of a project
Develop, update and implement project strategies to achieve objectives in the optimal timeline and budget, define and control achievement of critical project milestones, ensure critical issues are accurately addressed and resolved in a timely fashion.
Plan, execute and report Safety studies (including but not limited to drafting protocols, data capture forms, data output, and reports; serving as study monitor or sponsor person responsible).
Identify and select research facilities, establish contract agreements, maintain Sponsor Oversight and a positive business collaboration.
Determine needs and procure necessary study supplies, including test articles, reference standards, and appropriate formulations for Safety studies.
In collaboration with QA, ensure the quality and compliance of all development studies by conducting them according to the protocol and appropriate quality standards (GCP/GLP).
Coordinate, supervise and/or conduct data management, pharmacokinetics, and statistics for Safety studies as necessary.
Assume global responsibility and accountability for the Safety part of registration dossiers, which can include the preparation of the corresponding secondary documentation like Safety Experts Reports, User Safety Assessments, and Environmental Risk Assessments in partnership with Elanco Regulatory for regulatory agencies globally.
Attend meetings with regulatory agencies and present the safety plan, and respond to agency questions (verbally and in writing).
Actively participate and contribute to Development team activities, meetings, project coordination, improvement of processes, etc.
Prepare publications as needed in alignment with the Development team and Marketing.
Provide technical support and/or guidance to other R&D teams as a Subject Matter Expert.
Work with internal partners (i.e. TACs) to provide technical support to currently registered companion animal products.
Eli Lilly And Company