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Senior Director, Clinical Development

loyal36
United StatesRemote4w ago
Seniority
Lead

About the role

<h3>About Loyal</h3> <p>Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives.</p> <p>We're pioneering a new category of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age. We've already made significant progress in our mission to develop the first FDA-approved drugs to extend canine lifespan: as of early 2026 we've completed two of three major FDA review sections for our lead program, LOY-002, and are targeting submission of the third and final section later this year.</p> <p>Loyal is a <a href="https://loyal.com/posts/100m-for-first-longevity-drug">well-funded startup</a> with teams of scientists, veterinarians, engineers, operators, and creatives. You'll help us continue on our path of earning FDA approval for the first lifespan extension medicine for any species, and change what's possible for the dogs we love.</p> <h3>About the role</h3> <p>The Senior 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&nbsp; to study design and regulatory-facing protocol development&nbsp; through field execution, data interpretation, and evidence package generation.</p> <p>This is a highly cross-functional role that partners closely with R&amp;D, Clinical Operations, Project Leadership, Regulatory (FDA-CVM),CMC, and Commercial to ensure our studies are scientifically sound, operationally feasible, and aligned with pathways to approval.</p> <p>You will be reporting to our VP, Clinical and Veterinary Medicine .</p> <h3>Your daily work will include:</h3> <h3><strong>Clinical Strategy &amp; Program Development</strong></h3> <ul> <li>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.</li> <li>Build and manage detailed timelines for product development&nbsp;</li> <li>Communicate strategy and development timelines across multiple teams within Loyal</li> </ul> <h3><strong>Study Design &amp; Protocol Development</strong></h3> <ul> <li>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).</li> <li>Develop protocols, investigator brochures, SAP inputs, and essential documents tailored for investigators and staff in veterinary practice settings.</li> <li>Work closely with statisticians on statistical design, randomization schemes, interim analyses, and data quality plans.</li> <li>Partner with clinical operations to execute protocols with GCP compliance and serve as medical expert throughout in-life phase.</li> </ul> <h3><strong>Study Execution &amp; Medical Oversight</strong></h3> <ul> <li>Provide medical and scientific oversight for all clinical studies, including:</li> <ul> <li>Eligibility decisions</li> <li>Case reviews and AE/SAE reporting</li> <li>Protocol deviations and issue escalation</li> <li>Interpretation of clinical data trends during trial execution</li> </ul> <li>Support Clinical Operations with site engagement strategy, investigator training, and owner-facing communication frameworks.</li> <li>Partner with Veterinary Affairs on real-world applicability, disease models, and clinician feedback loops.</li> </ul> <h3><strong>Regulatory Leadership (FDA-CVM)</strong></h3> <ul> <li>Lead clinical components of regulatory interactions, including:</li> <ul> <li>Pre-Submission meetings</li> <li>Technical section responses</li> <li>Study protocol reviews with regulators</li> <li>Evidence summaries for FOI packages</li> </ul> <li>Ensure that all clinical components meet VICH, GCP, and CVM guidance standards.</li> </ul> <h3><strong>Cross-Functional Collaboration</strong></h3> <ul> <li>Work tightly with:</li> <ul> <li>R&amp;D to vet new drug targets and mechanisms and interpret pre-clinical data&nbsp;</li> <li>Regulatory to align development plans with CVM requirements.</li> <li>Veterinary Affairs to ensure clinic workflows and veterinary input shape study design.</li> <li>Clinical Operations on execution strategy, site selection, and quality.</li> <li>Commercial to ensure label-enabling claims are supported by data.</li> </ul> </ul> <h3><strong>Data Interpretation &amp; Evidence Generation</strong></h3> <ul> <li>Lead clinical data review, analyses, and messaging strategy.</li> <li>Develop authoritative veterinary medical clinical narratives for regulatory submissions, publications, and scientific communications.</li> <li>Author study reports, abstracts and external presentations as needed.</li> </ul> <h3><strong>Team Leadership</strong></h3> <ul> <li>Build and mentor a growing, high-functioning clinical development team with both veterinary medical and technical backgrounds.</li> <li>Foster a culture of scientific excellence, operational pragmatism, and veterinary investigator-centered study design</li> </ul> <h3>About you:&nbsp;</h3> <ul> <li>DVM or equivalent.</li> <li>10 -12+ years of experience in clinical development in animal health clinical development.</li> <li>Demonstrated experience designing and leading clinical trials, including protocol authorship, data review, and cross-functional collaboration.</li> <li>Prior oversight of safety evaluation, study conduct, and interpretation of clinical endpoints.</li> <li>Strong understanding of evidence requirements for regulatory approval.</li> <li>Ability to lead in a fast-paced, high-accountability biotech environment.</li> </ul> <h3><strong>Required</strong></h3> <ul> <li>Direct experience with FDA-CVM VICH guidelines.</li> <li>Experience in companion animal medicine, bonus if experience is in aging/longevity or quality-of-life endpoints.</li> <li>Background working with veterinary clinics, practice networks, or decentralized trial models.</li> </ul> <p>Salary range: $230,000 - $270,000</p> <h3>Loyal benefits</h3> <ul> <li>Full-coverage health insurance — medical, dental and vision — for you and your dependents</li> <li>$1,000 home office equipment stipend</li> <li>$1,200/year learning budget for books, courses, etc.</li> <li>$250/month wellness budget for gym, cleaners, spa, food, etc.</li> <li>All 3-day weekends are turned into 4-day weekends 🎉</li> <li>Unlimited vacation and paid holidays</li> <li>Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶</li> <li>Competitive salary</li> <li>Company equity options grant for new hires</li> </ul> <p>Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law.&nbsp;</p> <h3>Our values</h3> <p><strong>Moonshots, derisked methodically</strong></p> <p>Bringing the first longevity drug to market is an extremely difficult technical and social pursuit. To achieve this we must take bigger bets than the field has historically made, paired with the technical rigor to de-risk them step by step. We plan on both short and extremely long timescales, and we have the conviction to see our vision through to success or failure.</p> <p><strong>Opportunity is at the intersection</strong></p> <p>We lean into combining disciplines, expertise, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos.</p> <p><strong>Expertise without ego</strong></p> <p>Titles do not determine who has a voice. We push back on each other, ask questions instead of issuing orders, and try to prove ourselves wrong. We are emotionally attached to the outcome, not our personal hypotheses, and welcome being challenged instead of treating it as a threat.</p> <p><strong>High agency, high humility</strong></p> <p>Most of what we're doing has never been done before, so we can't rely on established precedents to guide our way. We move forward to generate clarity, build strategies resilient to the fact that we don't know what we don't know, and design small experiments where we can fail safely, without jeopardizing the bigger mission.</p> <p><strong>Lead with transparency and context</strong></p> <p>We proactively and consistently share the why behind our strategy - not just the what - because we believe sharing context enables great people to make great decisions.</p> <p><strong>Empathy and respect for all life</strong></p> <p>Our patients are not just numbers. We deeply respect the value of every life, large and small and take our ethical responsibility to the families we treat extremely seriously.</p>

Perks & benefits

  • Medical Insurance
  • Unlimited Vacation
  • Paid Time Off
  • Learning Budget
  • Mental Wellness Budget
  • Home Office Budget
  • Equity Compensation

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