Senior Director, Analytical Development

5 дн. назад

СШАDirectorRemote

fda regulatoryanalytical developmentosd analytics

Strategic leadership and hands-on role for analytical development in a veterinary medicine startup focused on longevity drugs for dogs.

О компании

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.

Обязанности

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.

Требования

Ph.D., M.S., or B.S. in Analytical Chemistry, Chemistry, or a related scientific discipline.
18+ years of progressive experience in analytical development and quality control for pharmaceutical products, with deep expertise in small-molecule oral solid dosage forms.
Demonstrated experience spanning early development, clinical programs, commercial launch, and post-approval lifecycle management.
Proven success building and leading analytical and/or QC organizations, including hiring, mentoring, and developing senior technical leaders.
Extensive experience with analytical method development, phase-appropriate validation, method transfer, and GMP QC operations.
Direct experience interacting with FDA on regulatory submissions, responses, meetings, and inspections, with working knowledge of ICH guidelines.
Track record of effective oversight of external GMP testing laboratories and analytical service providers, including governance, performance management, and quality issue resolution.
Track record of leading the analytical and control-strategy content of NADA/NDA CMC sections through approval, including deficiency responses and pre-approval inspections
Strategic mindset with the ability to translate scientific and regulatory complexity into clear, actionable business recommendations.
Comfortable operating in a fast-paced, growth-stage environment, balancing hands-on technical leadership with executive-level decision-making.
Excellent communication and influencing skills, with the ability to engage credibly with executive leadership, regulators, and external partners.

Будет плюсом

Knowledge of animal health regulatory requirements, including FDA CVM and VICH guidelines.

Условия

Salary Range: $230,000 - $280,000
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

Другое

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 identification and lifecycle management of CQAs, specifications, and control strategies.
Establish and oversee commercial QC operations, including governance of external GMP testing laboratories and service providers.
Provide executive oversight of deviations, investigations, OOS/OOT events, and CAPAs related to analytical and QC activities.
Serve as a senior analytical subject-matter expert in interactions with FDA Center for Veterinary Medicine (CVM) and other global animal health regulatory agencies, including regulatory submissions, responses, and inspections.
Select, manage, and govern external analytical laboratories, CDMOs (as applicable), and other partners to ensure technical performance, compliance, and cost effectiveness.
Build, scale, and lead a high-performing QC and analytical development organization, including hiring, mentoring, and developing senior technical leaders.
Establish operating models that balance internal capabilities with strategic outsourcing to support a growing and commercial portfolio.
Manage resource and budget planning, aligning analytical and QC investments with pipeline priorities and long-term business objectives.
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.
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.
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.
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.
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.
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.