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Sr. Director, CMC Supply Chain
4 months ago
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 an experienced Sr. Director, CMC Supply Chain to lead and manage the supply chain process at Loyal. This person will work within a multidisciplinary team to plan, execute, and deliver clinical trial material, and manage the launch and replenishment of drug product supplies. You will have the opportunity to directly influence program strategy and build a new SOP infrastructure within Loyal from the ground up.
Your work will directly impact the strategy and timing of clinical supply chain activities, drug substance supply, manufacturing, drug product production, distribution, and inventory management.
This role is for someone who has an accomplished track record in strategic planning and operational supply chain management, CMO selection and management, third-party logistics, and project planning/coordination including leading cross-functional teams for commercial product launch.
You will be reporting to our SVP of CMC, Jana Spes.
Your daily work will include:
Design, lead, and implement a comprehensive global supply chain strategy at Loyal with a focus on US market launch.
Product launch preparation: lead supply chain planning and execution to ensure timely, cost effective delivery of products in full, including building a robust replenishment plan.
Establish, manage, and improve the sales & operations planning process at Loyal in collaboration with commercial organization business partners.
Partner with Clinical Operations and other internal stakeholders to create and test clinical supply assumptions.
Execute supply chain direction and plan resource requirements sufficient to deliver robust supply solutions (ie. scenario planning, stockpiling, spend at risk, etc.)
Drive forecast planning and inventory management of all drug products in the pipeline. Provide global forecast planning and inventory control of all intermediates.
Oversee product purchasing and planning at contract manufacturing and logistic suppliers. Includes establishment and oversight of rolling forecasts for clinical and commercial products, and coordination of clinical packaging, logistics, and labeling operations for drug products.
Communicate the master production schedules for drug products both internally and externally, including a master production forecast for all strategic partners.
Manage and improve key supply chain interfaces with teams (Commercial, Clinical Operations, Quality Assurance, Regulatory Compliance, Sales & Marketing) such that inventory demands, and forecasts align at both the operational and revenue levels.
Participate in program strategy discussions to ensure that decisions align with the business direction and processes.
Develop and prepare long and short range global supply plans including potential capital investment plans at 3rd parties.
Establish and implement inventory policy and materials risk mitigation strategies.
Review and execute purchase orders for commercial API and finished products as approved and agreed upon.
Act as the primary point of contact with 3PL companies and actively manage relationships to ensure scheduled delivery goals are met.
Serve as Subject Matter Expert for supply and distribution on commercial launch teams and other forums as appropriate.
Develop and manage annual operating budgets and assure maximum functional area output with minimum cost and resource burden.
Ensure that the supply chain follows all supply and distribution corporate policies and that all company products abide by lawful and accepted practices of supply and distribution, including import and export of veterinary pharmaceutical products.
Lead the development of productivity and quality metrics/measurements (KPI’s) to ensure optimum efficiency, quality, and utilize metrics to drive supply chain operational improvements.
About you:
Bachelor’s or Master’s degree in Biology, Chemistry, Engineering or related technical field
10+ years of relevant experience in supply chain management and/or project management within a commercial-stage pharmaceutical or biopharmaceutical environment
Track record of skilled management of third-party contractors; can motivate and inspire action in the absence of direct reporting relationships
Demonstrated success in bridging the operations of various internal groups (API, pharmaceutics,QA, Regulatory, Clinical)
Ability to thrive in a multi-tasking and complex environment, working independently on supply plans and strategies, including scenarios and risk management planning with internal/external commercial partners
Experience proposing and leading projects that improve SC and S&OP processes
Experience in the development of a veterinary drug is a plus
Demonstrated experience in inventory management and forecasting
Detailed eye for logistics and problem solving
Willing to work and comfortable in a fast-paced startup environment with a dynamic team.
Familiarity with Google Workspace applications (e.g., Sheets, Slides, etc.)
How you work and think:
Gladly participate in a team-oriented culture
Self-starter who is always looking to push the ball forward
Able to work independently with minimal supervision
Detail-oriented, disciplined, naturally seeking ownership and responsibility, and happy to be working on a mix of the fascinating and the mundane
Professional and clear communicator with the ability to distill out the important information for relevant stakeholders no matter how complex the scenario
Growth mindset, value transparency, seek out feedback and iteration cycles.
Why you might not like this role:
This is a fast-paced, rapidly-scaling startup environment.
We may be comfortable with more ambiguity and uncertainty than you are accustomed to, as we like to test hypotheses early. 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.
You’ll need to be comfortable adapting to change, and operating in a fast-paced, highly-regulated environment.
What you'll gain from this role:
Experience leading the launch of a first-of-its-kind drug to market
A working environment that is positive, kind, thoughtful, and full of some of the smartest people in the industry
Experience building process and doing impactful work supplying product to the distribution chain and ensuring a successful launch
Full-coverage health insurance — medical, dental and vision — for you and your dependents
$1,000 home office equipment stipend
$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)
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.
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