Principal Research Scientist β Pet Health Clinical Development, Dermatology and Therapeutics
Responsibilities:
- Conduct and coordinate global Pet Health clinical development programs (effectiveness, target animal safety (TAS)) from inception through approval in initial target geographies.
- Plan and execute pilot and pivotal studies in compliance with global regulatory standards (GLP, vGCP, VICH).
- Author study protocols and reports; select internal sites or CROs; coordinate and manage studies.
- Formulate comprehensive clinical development plans for each new product and manage life cycle management to meet deadlines and quality attributes (GCP, GLP).
- Design and write protocols for laboratory and field efficacy studies and TAS with CDS/biostatistics/regulatory; select research facilities and researchers; ensure study monitoring.
- Analyze/interpret results; author study reports; partner with Regulatory Affairs for regulatory submissions and presentations to authorities/scientific meetings.
- Ensure quality assurance/regulatory compliance; participate/lead procedural activities (new processes/functional procedures).
- Attend scientific meetings and continuing education; stay current on advances in animal health and veterinary medicine.
Minimum qualifications:
- DVM or Ph.D. in an animal health related field (MS with experience considered).
- 5+ years product development experience in/closely associated with the pharmaceutical industry.
- Strong organization, motivation, communication; ability to manage multiple projects with attention to detail; self-directed.
- Current knowledge of pertinent global/national/federal regulations for therapeutic products.
Preferred qualifications:
- Understanding of R&D processes; strategic facilitator to drive clinical programs.
- Working knowledge of GCP/GLP/GMP and quality; proven experience with regulatory authorities.
- Experience working with external partners.
- Achievements aligned to Strategic Mindset, Business Insight, Cultivating Innovation, Driving a Vision.
Benefits and perks (highlights):
- Multiple relocation packages; two weeklong shutdowns (mid-summer and year-end) plus PTO; 8-week parental leave; 9 Employee Resource Groups; annual bonus offering; flexible work arrangements; up to 6% 401K matching.
Additional information:
- Location: Global Elanco Headquarters β Indianapolis, IN (Hybrid).