(Senior) Principal Scientist, Global Efficacy - Equine Therapeutic Area
Dechra · United States · 2 wk ago
RemoteRemoteScienceFull-time
The Opportunity
Lead the strategy, design, execution, and delivery of equine efficacy programs supporting veterinary drug development from early research through regulatory approval and lifecycle management.
Serve as the Efficacy Lead for development programs and, where required, provide cross-functional project lead.
Responsibilities
- Efficacy Strategy & Scientific Leadership
- Lead efficacy strategy across assigned equine development programs.
- Design and oversee in vitro, proof-of-concept, pharmacology, dose selection, and clinical field studies.
- Translate disease biology, clinical needs, and target product profiles into scientifically robust development plans.
- Integrate data into clear scientific and regulatory evidence supporting product approval and differentiation.
- Study Design & Execution
- Plan, execute, and deliver efficacy studies on time, within budget, and to regulatory quality standards.
- Ensure study integrity, animal welfare, clinical relevance, and compliance with GLP, VICH GCP, and applicable regulations.
- Maintain study progress, recruitment, risks, and data quality, driving timely issue resolution.
- Regulatory Support
- Prepare and review study protocols, reports, and regulatory submission documents.
- Collaborate with Regulatory Affairs to support agency interactions and responses regarding efficacy, endpoints, and target animal safety.
- External Collaboration & Stakeholder Management
- Build and manage relationships with CROs, investigators, referral hospitals, academic institutions, and Key Opinion Leaders.
- Ensure high-quality study delivery through effective oversight of external partners.
- Develop and maintain a strong external scientific network to support current and future pipeline opportunities.
- Disease Models & Translational Science
- Contribute to the development and validation of equine disease models and translational tools.
- Ensure scientific platforms are clinically relevant and support future portfolio needs.
- Cross-Functional Collaboration
- Partner with Regulatory, Safety, Clinical Operations, Statistics, CMC, Manufacturing, Commercial and Portfolio teams.
- Align efficacy strategies with regulatory expectations, commercial objectives, and real-world clinical practice.
- Clearly communicate risks, trade-offs, and recommendations to support informed decision-making.
- Project Leadership
- Lead cross-functional development teams and integrated project plans.
- Represent projects at governance meetings.
- Drive project execution, decision-making, risk management, and stakeholder alignment.
Requirements
- DVM/VMD or advanced degree (PhD, MSc, board certification) in veterinary, biomedical, pharmacology, or related discipline.
- 5-10+ years in veterinary pharmaceutical R&D, ideally in equine product development or clinical research.
- Expertise in efficacy study design, clinical development, pharmacology, regulatory requirements, and collaboration with CROs and external experts.
- Willingness to travel nationally and internationally.