Director, Clinical Development

About Loyal

Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives.

We’ve already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval within the next year.

Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies.

About the role

The Director of Clinical Development leads the team responsible for design, execution, and strategic direction of clinical programs across Loyal’s veterinary product portfolio. This role is responsible for driving end-to-end clinical strategy, from target product profile  to study design and regulatory-facing protocol development  through field execution, data interpretation, and evidence package generation.

Experience in human clinical drug development is considered if candidates demonstrate the ability to translate human clinical rigor into the realities and constraints of veterinary medicine (owner compliance, clinic workflow, clinical trial models, and companion animal endpoints).

This is a highly cross-functional role that partners closely with Veterinary Affairs, Clinical Operations, Regulatory (FDA-CVM),CMC, and Commercial to ensure our studies are scientifically sound, operationally feasible, and aligned with pathways to approval.

You will be reporting to our VP, Clinical and Veterinary Medicine .

Your daily work will include:

Clinical Strategy & Program Development

• 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

Study Design & Protocol Development

• 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.

Study Execution & Medical Oversight

• 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.

Regulatory Leadership (FDA-CVM)

• 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.

Cross-Functional Collaboration

• 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.

Data Interpretation & Evidence Generation

• 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.

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