Director/VP of Regulatory (Human Health)

Loyal is developing drugs to extend dog lifespan; we aim to build the defining aging company. Loyal was founded in early 2020 and has raised over $50M from Khosla, First Round Capital, Collaborative Fund, Longevity Fund, Quiet Capital, BoxGroup, and more.

Loyal is working on bringing to market the first drugs intended to extend dog lifespan (years of life) and healthspan (quality of life). We aspire to build a pharma brand people love around deeply technical products.

While we are currently focusing on dog drugs, our ultimate aim is to take what we learn in dogs to leapfrog into human aging drugs, and build the company that catalyzes and captures the public’s excitement around aging therapeutics.

We’re hiring a Senior Director or Vice President of Regulatory to lead the interactions with the FDA on our human health projects. This is a great opportunity to bring experience with FDA interactions to a start-up environment and the role will be critical to the success of this endeavor.

These activities will run alongside our existing interactions with the FDA CVM for our dog projects. We therefore offer an unprecedented opportunity to be involved in the regulatory strategy for dogs and humans in parallel.

Loyal is founded and led by a first-gen, female CEO – we encourage and look forward to diverse applicants.

As part of the Regulatory and Strategy Team you will:

• • Guide the strategy for FDA conversations on biomarkers, study design, and path to approval for human health longevity products
  • Lead the discussions with the FDA
  • Prepare documents for submission, working with teams across the company
  • Support teams with regulatory guidance around studies in human health
  • Contribute to the regulatory strategy for the dog products

Proficiencies:

• • Experience with approval of surrogate biomarkers by the FDA
  • Experience with approval of functional endpoints/biomarkers by the FDA
  • Experience with approval of small molecule products by the FDA
  • Experience with introducing novel approval pathways to the FDA
  • Experience with FDA meetings and other interactions
  • Good network of consultants
  • Experience preparing regulatory documents
  • Ability to think strategically and explain how tasks fit into the big picture
  • Ability to deal with ambiguity and to build novel paths to approval and market
  • Willing to read and learn about new areas of science
  • Knowledge of regulatory CMC is a bonus but not required

How you work and think:

• • Mission driven - able to prioritize and put day to day work in the context of the overall company goals
  • Excited by challenges and the opportunity to build something novel
  • Able to work in a fast paced and ever-changing environment
  • Detail oriented, disciplined, naturally seek ownership and responsibility, and happy working on a mix of the fascinating and the mundane
  • Concise, logical thinker who can communicate complicated topics with ease
  • Growth mindset, value transparency, seek out feedback and iteration cycles
  • Empathy to others and low ego

Why you may not like this role:

• • We are still relatively new, therefore many systems are either not in place or being iterated on. Tolerance for ambiguity and a bit of chaos is key
  • The strategy can change rapidly based on the science
  • As with other companies we are still figuring out hybrid remote working and communication
  • We may be comfortable with more ambiguity and uncertainty than you are used to, as we like to test hypotheses early You will have to be comfortable taking full responsibility for your area of expertise, with support and guidance from the rest of the team and company.

Logistics:

• • Full-time position. Can be remote or based in San Francisco, CA - our offices are on Market Street near Noe Valley
  • Competitive salary depending on your background & company shares
  • Full coverage health/dental/vision
  • Monthly learning budget for books and self-improvement
  • Start ASAP

Health | Good health is critical to every other human (and animal!) experience. We believe health is a fundamental right and are dedicating our lives to maximizing health and developing better medicines for the worst diseases.

Seeking & Feedback Loops | Uniquely in biology, there is a predetermined truth of whether a specific drug will work or not — we just have to catch up with biology! We seek out this truth and do not shy away from inconvenient truths. This holds for personal development too: we are always searching for feedback loops and embody a perpetual growth mindset.

Transparency | We believe full transparency in thoughts, opinions, intentions, and actions (both good ones and mistakes) is a better way to build a business and work together.

Morality & Empathy | We are developing medicines that may one day be given to a living animal, medicines that if designed badly could hurt that animal instead of help. This is a huge responsibility and should be respected as such. Our work needs to adhere to the strictest moral code and always integrate empathy for the patient.

Kindness | Great business(wo)men do not need to be ruthless — you can execute excellently with kindness.

Dog gifs | We love them.