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Responsible for global pet health biologic(s) development from positive proof of concept to registration. Accountable for the timely progression of assigned development projects through product development stage gate promotion process through leveraging effective project management skills, people leadership skills, clinical development expertise and CMC development expertise.
Day to day responsibilities
- Serve as development leader for designated projects: effective collaboration with Research/Early Development, Technical Development (CMC), Global Clinical Operations and Global Regulatory partners to execute assigned development project(s).
- Set clear goals and objectives for project team(s). Hold self and others accountable.
- Lead on-time delivery of clinical (Safety & Efficacy) and CMC development milestones in partnership with Global Clinical Operations, Technical Development, Regulatory and external partners.
- Lead preparation of project stage gate promotions including proactive identification of risk and mitigation strategy.
- Contribute to preparation of clinical study protocols and reports as author/co-author and reviewer.
- Contribute to the preparation of regulatory submissions.
- Influence and motivate project team members to push for the “slightly impossible”.
Required skills, experience, and education
- MS with >10 years or PhD and/or DVM with >5 years of R&D and regulatory vaccine experience and/or experience in leading multi-disciplinary vaccine R&D teams in the animal health industry.
Preferred skills experience and education
- PhD and/or DVM with >7 years of experience in leading multi-disciplinary international pet health vaccine/biologics development project team(s)/clinical development team(s) in the animal health industry.
- Significant experience in global pet health vaccine/biologics product development.
- Good understanding of GLP and GCP regulations as they apply to pet health vaccine/biologics product development study design and regulatory compliance.
- Good practical understanding of USDA and EU regulations relating to development of all aspects of veterinary vaccines/biologics.
- Proven ability to collaborate effectively across functions and provide leadership through influence.
- Reports to Sr. Director, Pet Health Biologics Development
- Direct reports: None
Location & Expected Travel percentage
- Additional locations includes Greenfield, IN; Fort Dodge, IA; Remote
- Travel: 10% to 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