Principle Research Scientist - Clinical Operations

Location: Indianapolis

Principle Research Scientist - Clinical Operations page is loaded## Principle Research Scientist - Clinical Operations locations:
Indianapolis, INtime type:
Full time posted on:
Posted Todayjob requisition :
R0024297
** At Elanco (NYSE: ELAN) – it all starts with animals!
**** As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.*
* ** At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.
**** At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
**** Making animals’ lives better makes life better – join our team today!**## Your Role:
Clinical Development Scientist, Parasiticides Conduct and coordinate global clinical development programs, including effectiveness and Target Animal Safety (TAS), from inception through approval in initial target geographies. Reporting to the Clinical Leader, this role designs and executes studies that advance Elanco’s innovation pipeline to customers.## Your Responsibilities
* Plan, coordinate, implement, and report high-quality clinical effectiveness and TAS programs to support development of new parasiticide products for pets and farm animals, including pilot and pivotal studies conducted in compliance with global regulatory standards and guidelines such as GLP, vGCP, and VICH.
* Formulate comprehensive clinical development plans for new products and build effective cross-functional relationships across Portfolio and Project Leadership, Regulatory Affairs and Pharmacovigilance, Clinical Development Sciences (CDS), R&D Quality Assurance, Marketing, Manufacturing, and Quality to ensure timelines and quality expectations (GCP, GLP) are met throughout development and lifecycle management.
* Execute individual clinical programs in collaboration with CDS, Biostatistics, and Regulatory Affairs, including designing and authoring protocols for laboratory and field efficacy studies and TAS studies to support regulatory approvals.
* Work with CDS to select appropriate internal research sites or external Contract Research Organizations (CROs) and qualified investigators to execute study protocols.
* Coordinate study monitoring activities to ensure compliance with applicable regulations, company policies, and management expectations.
* Analyze and interpret study results with support from Data Management, Medical Writing, Biostatistics, and internal or external subject matter experts, and author high-quality study reports.
* Partner with Regulatory Affairs to prepare clinical reports and datasets for submission to regulatory agencies and present data to regulatory authorities and scientific meetings.
* Ensure quality assurance and regulatory compliance and participate in or lead development of new processes and functional procedures.
* Attend scientific meetings and continuing education programs and remain current on scientific advances in the animal health industry and veterinary profession.## What You Need to Succeed (Minimum Qualifications)
* DVM or PhD in an animal health–related field preferred. An MS with relevant experience will be considered. An advanced degree (PhD) in parasitology in addition to a DVM is desirable.
* Five or more years of experience in product development within or closely associated with the pharmaceutical industry preferred.
* Demonstrated ability to organize and manage multiple projects simultaneously with strong attention to detail.
* Knowledge of applicable global, national, and federal regulations governing parasiticide product evaluation.
* Working knowledge of word processing and spreadsheet software.
* Self-motivated, with the ability to work and learn independently.
* Excellent written and verbal communication…