Senior Director, Clinical Development

Role Overview

• 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

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.

Tech Stack

• Google Cloud Platform

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