Reporting to the Executive Director or Clinical Leader, the incumbent will have the opportunity to design and execute studies that will deliver Elanco’s innovation pipeline to customers.
Basic Minimum Qualifications:
- A DVM or a Ph.D. in an animal health related field (molecular biology, internal medicine, microbiology, pharmacology, etc.) is preferred or MS degree with 10 years minimum relevant experience will be considered.
- Some experience in product development within or closely associated with the pharmaceutical industry is preferred.
- The incumbent must possess the ability to organize and manage a variety of projects at any one time demonstrating strict attention to detail.
- A basic understanding of pertinent global / national / federal regulations under which all products are evaluated is desired.
- A working knowledge of word processing and spreadsheet computer programs is also necessary.
- The incumbent must be self-motivated and able to work and learn without direct supervision.
- Excellent communication skills are required
Functions, Duties, Task:
The primary purpose of this position is the development of new pet health products (vaccines and monoclonal antibodies) by planning, coordinating, implementing, and reporting high quality clinical effectiveness and target animal safety (TAS) programs. Specifically, planning and executing pilot and pivotal studies in compliance with global regulatory standards (including GLP, vGCP & VICH) and guidelines. Authoring of study protocols and reports, selecting internal sites or Contract Research Organizations (CROs) to conduct studies, coordination and monitoring studies (directly or via CROs) are also included.
- Formulate comprehensive clinical development plans for each new product. Build effective relationships within and outside Research and Development (Portfolio and Project Leadership, Global Technical Development, Regulatory Affairs and Pharmacovigilance, R&D Quality Assurance, Marketing, Manufacturing and Quality) during development of products and life cycle management to assure that all parties involved meet critical deadlines and deliver work with appropriate quality attributes (GCP, GLP).
- Specific duties include executing individual clinical programs. In cooperation with other teams (i.e. Biostatistics, Regulatory Affairs), design and write protocols for laboratory and clinical efficacy studies and TAS to generate information that will lead to regulatory approval of products. Work cooperatively with Clinical Development Sciences to select suitable research facilities and qualified researchers to execute protocols. Coordinate with other teams to ensure study monitoring according to current applicable regulations, company policies, and management expectations. With support from other teams (i.e. Data Management, Medical Writing, Biostatistics, and internal / external SME reviewers), analyze and interpret results and author study reports. Work collaboratively with Regulatory Affairs to prepare reports and data for submission to regulatory agencies and present data to regulatory authorities and/or at scientific meetings.
- Ensure quality assurance/regulatory compliance and participate and/or lead administrative and procedural activities such as development of new processes and / or functional procedures.
- Attend scientific meetings, continuing education courses and keep abreast of scientific advances and new developments in the animal health industry and veterinary profession.
- Basic understanding of research and development processes
- Acting as collaborator, coordinator, and facilitator to drive clinical programs
- High potential for working with regulatory authorities
- Working knowledge of GCP/GLP/GMP and quality standards
- Demonstrated ability to work with external partners