Loyal

Healthcare's Leading End-to-End Digital Health Platform

Director, Clinical Development

DirectorDirectorFull TimeRemoteTeam 51-200H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

92 days ago

Salary

$165K - $200K / year

Postgraduate Degree8 yrs expEnglishGoogle Cloud Platform

Job Description

• 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, and protocol deviations and issue escalation. • 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 and study protocol reviews with regulators.

Job Requirements

  • DVM or equivalent.
  • 8–12+ 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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