Job description — Clinical Quality Manager
Location:
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 to bring the first product to market in 2025.
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
We’re seeking an experienced Clinical Quality Manager who will own data quality generated in Loyal’s pre-clinical and clinical studies. They are responsible for implementing quality assurance and quality control processes to ensure studies are conducted and data are generated, documented, and reported in compliance with applicable protocols, GLP, GCP, and regulatory requirements. The Clinical Quality Manager will lead quality initiatives, collaborating with cross functional teams (e.g. biostatistics, clinical operations and regulatory affairs).
Because Loyal’s clinical studies are long and complex, the Clinical Quality Manager will be responsible for building and implementing systems that maximize integrity of data throughout years long studies and prepare the data for the most efficient turn around to analysis and final study report (FSR) writing at study conclusion. The role will support primarily, but not exclusively, clinical operations and biostatistics teams to ensure that our clinical trials maximize retention of as much of the hard-earned data as possible. .
You will be reporting to our Director of Quality - Amanda Koperski.
Your daily work will include:
- Leading the development of a rigorous quality control program for Loyal’s clinical team and, where appropriate, collaborating with operational quality to integrate processes within the company quality system.
- Mastery of clinical protocols and study endpoints to ensure collected data is is compliant with the protocol guidelines
- Site visits to clinical trial sites (vet clinics) with clinical research associates (CRAs) to ensure procedural quality at the data collection source
- Operating within electronic data capture systems and study drug inventory management systems (such as IWRS) to navigate large numbers of study subjects and ensure consistency and management of data across study sites
- Performing user acceptance testing of electronic data capture builds specific for each clinical study
- Identifying discrepancies and inconsistencies in data collection and, if necessary, providing remediation or training to clinical operations team
- Working closely with CRAs to standardize data collection methods and quality processes from site initiation through study close out
- Utilize guidance documents and standards to interpret for guidance, ensuring quality and compliance to regulations
- Own inspection readiness programs pertaining to pre-clinical and clinical studies
- Development and implementation of quality plans
- Develop risk based, efficient audit plans at the study and site level
- Partner with clinical team for risk identification, management, and mitigation activities
- Oversight of deviation root cause analysis and CAPA development for pre-clinical and clinical studies
- Identify, generate, and communicate appropriate quality metrics to the team and management
- Provide GCP guidance on questions arising from day to day clinical trial activities
About you:
- Bachelor’s degree or equivalent experience required, preferably in animal science, biology, veterinary, or related life sciences
- 5+ years experience in GCP/PV, clinical development, or QA
- Excellent communication, presentation, and interpersonal skills
- Exceptional organizational and follow-up skills, as well as attention to detail.
- Able to travel up to 40% regionally and nationally.
- Working knowledge of regulations, standards, and guidances for Good Laboratory Practice and (Veterinary) Good Clinical Practice
- Proficiency in electronic data capture systems and study drug inventory management systems
- Ability to analyze complex problems and develop multiple solutions within regulatory guidance
Preferred but not required
- Understanding of product development processes
- Experience working with VICH GCP studies
- Experience in clinical research and/or product development in animal health
- Experience working with Prelude EDC
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 🐶
- Annual company retreat at beautiful locations across the country (recently: Tahoe, Cape Cod)
- Competitive salary
- Company equity options grant for new hires
Salary range: $110k - $150k
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.
