Healthcare's Leading End-to-End Digital Health Platform
Senior Director, Clinical Development
Location
United States
Posted
19 days ago
Salary
$230K - $270K / year
Seniority
Senior
Job Description
Senior Director, Clinical Development
Loyal
• Own the clinical development strategy for our portfolio of veterinary drug programs, including target product profiles, pivotal pathway planning, and key endpoints aligned with CVM expectations. • Build and manage detailed timelines for product development • Communicate strategy and development timelines across multiple teams within Loyal • Design companion animal clinical trials (pilot, field safety, and pivotal effectiveness studies) with appropriate statistical powering, endpoint justification, inclusion/exclusion parameters, and handling of operational constraints (e.g., heterogeneous populations, compliance variability). • Develop protocols, investigator brochures, SAP inputs, and essential documents tailored for investigators and staff in veterinary practice settings. • Work closely with statisticians on statistical design, randomization schemes, interim analyses, and data quality plans. • Partner with clinical operations to execute protocols with GCP compliance and serve as medical expert throughout in-life phase. • Provide medical and scientific oversight for all clinical studies, including: • Eligibility decisions • Case reviews and AE/SAE reporting • Protocol deviations and issue escalation • Interpretation of clinical data trends during trial execution • Support Clinical Operations with site engagement strategy, investigator training, and owner-facing communication frameworks. • Partner with Veterinary Affairs on real-world applicability, disease models, and clinician feedback loops. • Lead clinical components of regulatory interactions, including: • Pre-Submission meetings • Technical section responses • Study protocol reviews with regulators • Evidence summaries for FOI packages • Ensure that all clinical components meet VICH, GCP, and CVM guidance standards. • Work tightly with R&D to vet new drug targets and mechanisms and interpret pre-clinical data • Regulatory to align development plans with CVM requirements. • Veterinary Affairs to ensure clinic workflows and veterinary input shape study design. • Clinical Operations on execution strategy, site selection, and quality. • Commercial to ensure label-enabling claims are supported by data. • Lead clinical data review, analyses, and messaging strategy. • Develop authoritative veterinary medical clinical narratives for regulatory submissions, publications, and scientific communications. • Author study reports, abstracts and external presentations as needed. • Build and mentor a growing, high-functioning clinical development team with both veterinary medical and technical backgrounds. • Foster a culture of scientific excellence, operational pragmatism, and veterinary investigator-centered study design
Job Requirements
- DVM or equivalent.
- 10 -12+ years of experience in clinical development in animal health clinical development.
- Demonstrated experience designing and leading clinical trials, including protocol authorship, data review, and cross-functional collaboration.
- Prior oversight of safety evaluation, study conduct, and interpretation of clinical endpoints.
- Strong understanding of evidence requirements for regulatory approval.
- Ability to lead in a fast-paced, high-accountability biotech environment.
- Direct experience with FDA-CVM VICH guidelines.
- Experience in companion animal medicine, bonus if experience is in aging/longevity or quality-of-life endpoints.
- Background working with veterinary clinics, practice networks, or decentralized trial models.
Benefits
- Full-coverage health insurance — medical, dental and vision — for you and your dependents
- $1,000 home office equipment stipend
- $1,200/year learning budget for books, courses, etc.
- $250/month wellness budget for gym, cleaners, spa, food, etc.
- All 3-day weekends are turned into 4-day weekends 🎉
- Unlimited vacation and paid holidays
- Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶
- Competitive salary
- Company equity options grant for new hires
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