The Structure of (one) Early-Stage Biotech Co
I get a lot of questions on how I have structured Loyal as we have grown. Here is how we are currently doing it.
Our Org Structure at a Glance
For context: Loyal is a clinical-stage biotech company developing drugs to extend dog lifespan. Each department at Loyal is represented by a box. The head of each group either is or reports into the CEO or a VP.
The Y-axis does not represent ‘superiority’ or seniority in the company; it represents the breadth of that department across all others. For example, my role as CEO impacts every other group. Project Management does not play a significant role in People Ops, but it coordinates the backend for all other groups. And so on.
The core of the company at this stage is R&D. All other groups exist to support and translate out what R&D develops. As our products mature, R&D will remain core to the company but other departments like ClinDev & Veterinary Medicine will become centers of gravity too.
There are a few important company-specific variables that influenced how we decided to structure the company:
We do most of our research via CROs. The only research we do in house are mouse lifespan studies and some molecular work.
We will remain approx. 50% remote for the foreseeable future.
We have <5 portfolio products.
We do not develop novel compounds.
We are ~17 people and have been operating for little over a year.
What Each Group Does
CEO/CoS - Set the direction of the company, fundraising, hiring, management, mentorship, partnerships
People Ops - HR, culture, accounting, operations, administrative work
Project Management, Strategy - Standard operating procedures, timeline management, project mapping, budgeting, target product profiles, pre- and post-mortem coordination
Regulation - FDA submissions, compliance audits, quality assurance & control, regulatory strategy
CMC - Chemistry, Manufacturing, and Controls. The manufacturing of the drug product
Quantitative Research & Bioinformatics - our computational biology core
Translational & Veterinary Medicine - Coordination of R&D’s molecular work with the end-user’s (veterinarian and dog owner) needs and concerns. Veterinarian-facing.
R&D - Research and Development. Takes ideas for new aging pathways and drugs and brings them to proof-of-concept.
Research Operations - designs, manages, and coordinates studies conducted by Contract Research Organizations (CROs)
Scientists - design and execute on in-house laboratory work (in vivo & in vitro)
Clinical Development & Operations - Designs canine clinical studies, submits protocols, runs clinical trials, interprets results
Consumer - Dog-owner facing. Ensures drug products meet an unmet need for dog owners, price point viable, product convenience and compliance, builds Loyal’s brand.
Our Guiding Frameworks
We made a couple of key decisions that have driven our organizational structure.
// We avoid silos as much as possible. We think regular transparent communication between groups is key to building a successful product. More on this below.
// Silos are only used to facilitate focus. Silos are common in biotechs because they are easier to manage. We strategically silo projects when it’s only relevant to that team; e.g., a very early idea in diligence with R&D may not be brought up with the ClinDev team. We do this to help keep the information overload to minimum.
// Determine core focus of that group and delegate away all other parts. Because of the technical difficulty of what we are trying to build - a drug to extend lifespan - it is especially important that we abstract away the other parts of running the company (e.g., timeline management) so they can have as much time per week to focus on their part.
// Allow the experts to lead; exec team is there to facilitate and ensure clarity of thought.
// Promote within. Because of the specialized nature of what we are building, there is not an obvious source of candidates. Continuity and institutional knowledge are especially critical for us.
Avoiding silos…..
The skillset to work in, for example, R&D differs significantly from those in CMC or Veterinary Medicine, but all are critical for bringing a new product to market. The technical difficulty combined with the criticality of each of these groups means building structure to facilitate transparent and clear communication. It is critical for these teams to work together from early in the life of a new drug to avoid problems later.
Here is an example how each group may participate in the development of a new drug:
R&D - identifies that up-regulating protein X may positively impact a disease. Identifies a lead compound that does this.
CMC - determines the drug formulation(s) that may be viable with this lead compound, approximate unit costs, and other manufacturing variables of note
Veterinary Medicine - determines which drug products would be most favorable to a vet, whether the disease is an unmet need, current standard of care and whether our product could be competitive
Consumer - determines the willingness to pay of a dog owner and whether this coordinates with CMC’s unit costs
Clinical Development - how to assess our lead drug for efficacy in clinical trials, if FDA-approved endpoints for this disease already exist
In any part of this process the new drug may be killed. Understanding the development path and its risk before significantly investing is key to ensuring you don’t waste money or time on a product that may never work for a reason that was predictable before this investment.
…..without distracting the team.
Silos emerge because it is both challenging and distracting to have your finger on the pulse of the entire company. In larger companies, silos often compete for resources or decision making power, pitching them against each other.
Project management is key
Somewhat controversially, one of our first hires was a Project Manager and this team continues to be a significant portion of the total team. We also have a VP of Project Management & Strategy, our second executive hire after the VP of Aging Biology.
Think of it as the skeleton and tendons of the company - PM gives the company a strong base off of which to build muscle.
PM is responsible for ensuring coordination upon the groups. As they are independent from the other groups, they are not biased to any one group’s desire or opinion. They make it effortless to coordinate and take the burden off of each group, allowing groups to put maximal energy into their specific goals.
Order of building
We approximately built the groups in this order:
Research Ops
R&D VP
Translational Medicine
Consumer
People Ops
Program Development/CMC/strategy
Clinical Development & Ops
Veterinary Medicine
Quantitative Research and Bioinformatics
Doing it again, I would have hired the Program Development/CMC/Strategy team sooner.
Other facets of our corporate structure and strategy:
Extreme clarity on the vision & the role of each group in achieving company’s goals
We are a company with a long-term mission: lifespan extension. Decisions we make now will determine our success or failures year from now. When you are building a drug, seemingly tiny decisions can be deceivingly impactful. This is complicated by the technical difficulty of each step. As CEO, I will never have enough training to ask the hard-hitting technical questions.
Therefore, the best way to ensure that our decisions stand the test of time is to 1) have a truly mission motivated team, 2) ensure they completely understand the company’s mission and strategy for achieving it, and 3) give them the resources they need (capital, expertise, headcount) to execute excellently.
Heavy use of specialist consultants
There are very few people who have pre-existing expertise in the areas we work in. Therefore, we bias to hire cognitively flexible and truth seeking generalists that have a strong scientific background in a tangential field, who then coordinate with the best experts we can find for each aspect of a problem. For example, our CMC lead works with four consultants who are specialists who together cover all facets of our product development.
Scaling Titles
Currently, our titling scheme from most to least senior is: CxO, Vice President, Director, Head, Manager, Associate.
Titles are important biotech. Matching the seniority to what someone may get at a bigger company can be critical to close a hire. Additionally, little things like calling someone a scientist versus a research associate can grease the wheels for the rest of their career.
final notes: the correct structure for your budding biotech differs a lot on what your company does. This PM-heavy structure likely won’t be necessary for a company that does a lot of in-house laboratory work, for example.
I tried to address the key questions I had when designing this structure. If you think of something I should add, please email me at celine@loyalfordogs.com