Research Scientist-Safety

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.

Company Overview

Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Our worldwide headquarters and research facilities are in Greenfield, Indiana, but we have regional R&D hubs in Australia, Brazil and Europe.

Basic Qualifications

• Ph.D. in Biology/Chemistry or Doctorate of Veterinary Medicine (DVM) or related field) and broad experience in drug safety and a good background in regulatory requirements with 3+ years experience in the Veterinary or Human Pharmaceutical industry , or
• MS with broad experience in drug safety and a good background in regulatory requirements with 6+ years experience in the Veterinary or Human Pharmaceutical industry

Additional Information

• Travel Percentage : Approximately 10-20%
• 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

Additional Skills/Preferences

• Proven proficiency in global drug development e.g. Study or Program Design, FDA concurrence, product approvals.
• Demonstrated success in managing contractors and relationships with external parties
• Board certification as toxicologist (DABT, ERT, ECVPT) is considered as an ideal additional asset.
• Exceptional problem solving and decision-making skills with the proven ability to think beyond a study outcome to a project/program outcome
• Knowledge of CM&C (chemistry, manufacturing and control), clinical trial design, pharmacokinetics and statistics
• Proven track record of designing and implementing safety programs from early development through registration/approval
• Must be able to work productively in an interdisciplinary and global team environment with the proven ability to communicate across multiple disciplines effectively
• Proven ability to interpret, discuss and present data in a clear, concise manner and provide recommendations at the project level
• Demonstrated proficiency of GLP/GCP and quality principles
• Advanced planning and tracking skills, capable of managing multiple projects with respect to priorities and self-management
• Proven "team player" mentality, with the goal of organizational success over individual success