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Senior Director, Analytical Development

Loyal · Remote · Remote - US · $230k–$280k

Posted by Loyal on their careers site · View the original posting

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About Loyal

Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives.

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.

Loyal is a well-funded startup 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.

About the role

The Senior Director, Analytical Development provides strategic leadership for all analytical development across Loyal’s pipeline and future commercial products. This is a hands-on role in a lean, virtual company. You’ll set the strategy and do the work, including authoring the analytical content of CVM submissions. You’ll build and scale the AD organization, leveraging internal and external partners, with deep expertise in OSD analytics and FDA regulatory requirements.

You will be reporting to our Vice President of Manufacturing.

Your daily work will include

  • Set and execute the global analytical development and quality control strategy aligned with Loyal’s corporate and CMC objectives.
  • Serve as the accountable executive for GMP analytical operations, ensuring inspection-ready systems, data integrity, PAI readiness at Loyal and CDMOs, and sustained regulatory compliance.
  • Act as a senior CMC leader on cross-functional program teams, influencing development strategy, timelines, and investment decisions.
  • Lead the development, validation, transfer, and lifecycle management of analytical methods and control strategies, with immediate focus on small-molecule oral solid dosage products, while supporting additional modalities as the pipeline evolves.
  • Own the dissolution strategy, including discriminating method development, validation, and the dissolution data package for CVM submissions.
  • Author and review the analytical content of the NADA CMC technical section, including method validation summaries, specification justifications, stability narratives, and deficiency responses.
  • Lead the drug substance analytical strategy including method development and validation, specifications, impurity control, stability programs, reference standards, and testing at API manufacturers and starting material suppliers
  • Own the stability strategy across the pipeline, including protocol design, statistical evaluation, shelf-life assignment and trending.
  • Lead cross-functional identific

[…]
ual 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

Moonshots, derisked methodically

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.

Opportunity is at the intersection

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.

Expertise without ego

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.

High agency, high humility

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.

Lead with transparency and context

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.

Empathy and respect for all life

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.