Senior Director, Clinical Development

📋 Description

• Take charge of the clinical development strategy for our portfolio of veterinary drug initiatives, which includes defining target product profiles, planning pivotal pathways, and establishing key endpoints that align with CVM expectations.

• Create and oversee comprehensive timelines for product development.

• Relay the strategy and development timelines across various teams within Loyal.

• Design clinical trials for companion animals (pilot, field safety, and pivotal effectiveness studies) with suitable statistical power, justified endpoints, inclusion/exclusion criteria, and consideration of operational challenges (e.g., diverse populations, compliance variability).

• Develop protocols, investigator brochures, statistical analysis plan inputs, and essential documents specifically tailored for investigators and staff in veterinary practice environments.

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

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

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

• Making eligibility decisions

• Conducting case reviews and reporting AEs/SAEs

• Managing protocol deviations and escalating issues

• Interpreting clinical data trends during the 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 loops.

• Lead the clinical aspects of regulatory interactions, including:

• Pre-Submission meetings

• Responses to technical sections

• Study protocol reviews with regulatory bodies

• Evidence summaries for FOI packages

• Ensure that all clinical elements comply with VICH, GCP, and CVM guidance standards.

• Collaborate closely with R&D to evaluate new drug targets and mechanisms while interpreting pre-clinical data.

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

• Engage with Veterinary Affairs to ensure that clinic workflows and veterinary perspectives inform study designs.

• Partner with Clinical Operations on execution strategies, site selection, and quality assurance.

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

• Lead the review of clinical data, analyses, and messaging strategies.

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

• Write study reports, abstracts, and create external presentations as necessary.

• Build and mentor a growing, high-performing clinical development team with both veterinary 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 authorship of protocols, data review, and cross-functional collaboration.

• Previous oversight of safety evaluations, study execution, and interpretation of clinical endpoints.

• Strong understanding of evidence requirements for regulatory approvals.

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

• Direct experience with FDA-CVM and VICH guidelines.

• Experience in companion animal medicine, with a bonus for expertise 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/year learning budget for books, courses, and more.

• $250/month wellness budget for gym memberships, cleaning services, spa treatments, food, etc.

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

• Unlimited vacation and paid holidays.

• Paw-ternity leave — adopt a dog and enjoy a day off with your new family member 🐶.

• Competitive salary.

• Company equity options grant for new hires.