Director, Clinical Operations
Loyal
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
Responsible for leading the strategic planning and execution of clinical trials across all phases (observational, pilot, and pivotal) within established timelines and budgets. The candidate should demonstrate strong mutli-tasking management skills, confidence in working independently, and have a proven ability to lead a team to deliver on key study milestones. In addition, the candidate must have experience managing and providing oversight of clinical studies outsourced to third party vendors (ie, CROs, central labs, etc.) but also experience managing studies in-house without a full-service CRO. This role is critical to ensuring the timely delivery of high-quality clinical data to support regulatory submissions and drive Loyal products forward to market.
You will be reporting to our Senior Director, Clinical Operations.
Your daily work will include:
- Lead and manage all operational aspects of assigned clinical trials from initiation to close-out, including data analysis and final study report (FSR) writing.
- Translate corporate goals into actionable clinical strategies and ensure their successful execution.
- Develop and review protocols, informed consent forms (ICFs), study manuals, department guidances and tools, and regulatory submission documents.
- Has an in-depth understanding of study protocols and study procedures to develop team knowledge, share best practices, recommend continuous improvements, and provide training as appropriate/required.
- Act as the clinical operations lead on cross-functional study teams, building strong partnerships with regulatory, clinical development, biostatistics, quality, and medical monitoring.
- Facilitate partnerships with Investigators and vendors.
- Oversee vendor selection and management, including scope of work and contract negotiations, performance management, and issue resolution.
- Monitor patient recruitment, site activation, site close-out, and other clinical site metrics while proactively assessing risk and implementing mitigation strategies.
- Ensure internal team and clinical site adherence to study timelines, budgets, and key company milestones within each study.
- Manage, mentor, and develop junior team members.
- Ensure compliance with VICH-GCP, FDA/CVM regulations, and internal SOPs.
- Oversee site monitoring, data collection, and data reviews to ensure inspection readiness.
- Participate in audits/audit preparation, corrective and preventative action (CAPA) plans, and support other regulatory activities (submissions, new animal drug application (NADAs), etc.), as needed.
- In collaboration with finance, create, oversee, track, and manage study budgets and financial reports.
- Review and approve vendor invoices against scope of work and deliverables.
- Provide study status updates, including presentations and reports, to senior management.
- Contribute to developing and revising company standard operation procedures (SOPs) and department work instructions/guidances.
- Travel (up to 25%) required.
About you:
- Bachelor’s degree (BS/BA) in life sciences, animal sciences, biology, veterinary medicine, or health care.
- Minimum 10 years of clinical research experience in human drug development (pharmaceutical/biotech industry) or veterinary health/medicine.
- Minimum 3 years of experience in a Sr. Manager role
- Proven track record of managing phase 1 - 3 clinical trials across various therapeutic areas.
- Extensive knowledge of GCP VICH GL9 and/or GCP ICH E6(R2) regulations.
- Strong leadership skills and ability to manage teams.
- Exceptional communication, presentation, and problem-solving skills.
- Thrives in a dynamic, fast-paced biotech environment.
Loyal 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
Salary Range: $152,000 - $218,000
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.
Our values
Lean into moonshots
We don’t settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have.
Opportunity is at the intersection
We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos.
Expertise without ego
Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it.
Learning by doing
Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes.
Lead with context
We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed.
Empathy and respect for all life
Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.