Senior Director, Clinical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership of the clinical development strategy for our suite of veterinary drug initiatives, which includes target product profiles, pivotal pathway planning, and key endpoints in alignment with CVM expectations.

• Create and oversee comprehensive timelines for product development.

• Convey strategy and development timelines across various teams within Loyal.

• Design clinical trials for companion animals (pilot, field safety, and pivotal effectiveness studies) ensuring appropriate statistical power, endpoint justification, inclusion/exclusion criteria, and management 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 environments.

• Collaborate closely with statisticians on statistical design, randomization schemes, interim analyses, and data quality plans.

• Work alongside clinical operations to implement protocols in compliance with GCP and serve as a medical expert throughout the in-life phase.

• Provide medical and scientific oversight for all clinical studies, including:

• Eligibility assessments

• Case reviews and adverse event/serious adverse event reporting

• Protocol deviations and issue escalation

• Interpretation of clinical data trends during trial execution

• Assist Clinical Operations with site engagement strategies, investigator training, and communication frameworks directed at owners.

• Collaborate with Veterinary Affairs on real-world applicability, disease models, and clinician feedback mechanisms.

• Lead clinical aspects of regulatory interactions, comprising:

• Pre-Submission meetings

• Responses to technical sections

• Study protocol reviews with regulators

• Evidence summaries for FOI packages

• Ensure all clinical components adhere to VICH, GCP, and CVM guidance standards.

• Work closely with R&D to evaluate new drug targets and mechanisms and interpret pre-clinical data.

• Coordinate with Regulatory to align development plans with CVM requirements.

• Collaborate with Veterinary Affairs to ensure clinic workflows and veterinary input inform study design.

• Partner with Clinical Operations for execution strategy, site selection, and quality assurance.

• Work with Commercial to ensure that label-enabling claims are substantiated by data.

• Lead clinical data review, analysis, and messaging strategy.

• Develop authoritative veterinary medical clinical narratives for regulatory submissions, publications, and scientific communication.

• Author study reports, abstracts, and external presentations as necessary.

• Build and mentor a dynamic, high-functioning clinical development team with both veterinary medical and technical expertise.

• Cultivate a culture of scientific excellence, operational pragmatism, and veterinary investigator-centered study design.

⛳️ Requirements

• DVM or equivalent qualification.

• 10 to 12+ years of experience in clinical development within the animal health sector.

• Proven experience in designing and leading clinical trials, including protocol authorship, data review, and cross-functional collaboration.

• Prior experience in safety evaluation, study conduct, and the interpretation of clinical endpoints.

• Strong understanding of evidence requirements for regulatory approval.

• Ability to thrive in a fast-paced, high-accountability biotech environment.

• Direct experience with FDA-CVM VICH guidelines.

• Experience in companion animal medicine; bonus points for experience in aging/longevity or quality-of-life endpoints.

• Background in working with veterinary clinics, practice networks, or decentralized trial models.

🏝️ Benefits

• Comprehensive health insurance coverage — medical, dental, and vision — for you and your dependents.

• $1,000 stipend for home office equipment.

• $1,200 annual learning budget for books, courses, etc.

• $250 monthly wellness budget for gym, cleaning services, spa, food, etc.

• All 3-day weekends are extended to 4-day weekends 🎉.

• Unlimited vacation time and paid holidays.

• Paw-ternity leave — adopt a dog and receive a day off to welcome your new family member 🐶.

• Competitive salary.

• Company equity options grant for new hires.