People Matter

Clinical Development Manager

Loyal

Loyal

Administration
United States · Remote
Posted on Saturday, June 1, 2024

About Loyal

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

We’ve already achieved significant milestones on our path to gaining 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

Loyal is less than 12 months away from the projected launch of our first product. We’re seeking a Clinical Development Manager to help bring the first FDA approved longevity drug to market and further expand Loyal’s pipeline.

You will be responsible for the clinical development of Loyal’s programs and be the primary owner of the following activities: development and finalization of clinical protocol, Investigator’s Brochure, Informed Consent Forms (ICF) and study report, medical monitoring, and training on protocol compliance. Additional responsibilities include assisting with regulatory submissions and providing clinical perspectives (ie, acting as an internal consultant) to colleagues in clinical operations, commercial, data science, manufacturing, preclinical pharmacology and pharmacokinetics.

You will report to our Senior Director of Clinical Development, Ellen Ratcliff, DVM.

Your daily work will include:

  • Medical monitoring of ongoing clinical trials, requiring (1) solid understanding of the pharmacology/toxicology profile of drug compounds and (2) strong clinical competency in assessing medical observations/lab findings.
  • Planning and authoring regulatory submissions for clinical trials, final study reports (including statistical analysis discussion and interpretation).
  • Analyzing R&D data and leveraging results to design and execute optimal clinical studies.
  • Contributing to the design of development pathways, starting from preclinical studies through full FDA CVM approval.
  • Frequent interactions with pre-clinical teams, data scientists, drug development, regulatory and strategy and clinical operations teams.

About you:

  • DVM or equivalent degree from an AVMA-accredited school.
  • 5+ years of clinical practice experience.
  • Prior industry experience as medical monitor/study director is nice-to-have, but not required.
  • Familiarity with good clinical practice (GCP) guidelines and regulations.
  • Enjoy serving as the veterinary medical expert to bridge gaps between diverse subteams/functions, ranging from R&D, clinical operations, manufacturing and commercial/go-to-market activities.
  • Tech-savvy, or can be trained quickly to use new software, platforms or applications.
  • Think creatively, anticipate challenges, and develop innovative solutions to complex problems.
  • Committed to scientific excellence, integrity, and ethical conduct in all aspects of drug development.

How you work and think:

  • Gladly participate in a team-oriented culture.
  • Self-starter who takes ownership and responsibility.
  • Happy to work on a mix of (mostly) the fascinating and (occasionally) the mundane.
  • Clear communicator who can distill complex information into concise summaries and action plans.
  • Growth mindset, value transparency, seek out feedback and iteration cycles.

Reasons you might not like this role:

  • This is a fast-paced, rapidly-scaling startup environment.
  • We’re still relatively new, with many systems and processes either not in place or being developed, so you’ll need to tolerate ambiguity.
  • Development strategy can change rapidly based on science and/or business requirements.
  • You’ll need to be comfortable taking full responsibility for your area of expertise, with support and guidance from the rest of the team and company.
  • The spotlight: veterinarians on the clinical development team exert significant influence on the strategy, timelines, study designs, data analysis and regulatory pathway to drug approval.

What you will gain from this role:

  • Enabling the approval and launch of the first longevity drugs approved by the FDA.
  • Working and leading in an entrepreneurial environment that is constructive, kind, and thoughtful, alongside some of the most passionate people wanting to do meaningful work.

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

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 do not 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 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.