Loyal

• Own the clinical development strategy for our portfolio of veterinary drug programs, including target product profiles, pivotal pathway planning, and key endpoints aligned with CVM expectations. • Build and manage detailed timelines for product development • Communicate strategy and development timelines across multiple teams within Loyal • Design companion animal clinical trials (pilot, field safety, and pivotal effectiveness studies) with appropriate statistical powering, endpoint justification, inclusion/exclusion parameters, and handling of operational constraints (e.g., heterogeneous populations, compliance variability). • Develop protocols, investigator brochures, SAP inputs, and essential documents tailored for investigators and staff in veterinary practice settings. • Work closely with statisticians on statistical design, randomization schemes, interim analyses, and data quality plans. • Partner with clinical operations to execute protocols with GCP compliance and serve as medical expert throughout in-life phase. • Provide medical and scientific oversight for all clinical studies, including: • Eligibility decisions • Case reviews and AE/SAE reporting • Protocol deviations and issue escalation • Interpretation of clinical data trends during trial execution • Support Clinical Operations with site engagement strategy, investigator training, and owner-facing communication frameworks. • Partner with Veterinary Affairs on real-world applicability, disease models, and clinician feedback loops. • Lead clinical components of regulatory interactions, including: • Pre-Submission meetings • Technical section responses • Study protocol reviews with regulators • Evidence summaries for FOI packages • Ensure that all clinical components meet VICH, GCP, and CVM guidance standards. • Work tightly with R&D to vet new drug targets and mechanisms and interpret pre-clinical data • Regulatory to align development plans with CVM requirements. • Veterinary Affairs to ensure clinic workflows and veterinary input shape study design. • Clinical Operations on execution strategy, site selection, and quality. • Commercial to ensure label-enabling claims are supported by data. • Lead clinical data review, analyses, and messaging strategy. • Develop authoritative veterinary medical clinical narratives for regulatory submissions, publications, and scientific communications. • Author study reports, abstracts and external presentations as needed. • Build and mentor a growing, high-functioning clinical development team with both veterinary medical and technical backgrounds. • Foster a culture of scientific excellence, operational pragmatism, and veterinary investigator-centered study design

• Own and drive Loyal's controllership function, including monthly close, CRO/CMO accrual reconciliation, technical accounting (ASC 606, 718, 842, 330; IRC §382; R&D tax credits), and audit management from auditor selection through signed opinion delivery. • Build inventory and cost-of-goods tracking ahead of commercial launch. Stand up gross margin reporting and the financial infrastructure required for a revenue-generating operation. • Build on and enforce internal controls while still enabling speed and judgment - purchase order requirements, contract approval workflows, and segregation of duties - documented for audit readiness. • Own the financial model. Build and maintain an integrated P&L, balance sheet, and cash flow model across pipeline programs, milestone timelines, and capital deployment scenarios. • Lead program valuation - NPV, DCF, and rNPV modeling - and support portfolio prioritization, partnering discussions, and Board capital allocation reviews. • Maintain a rolling cash runway model linked to program spend, headcount, and financing events. Track budget vs. actual at the department level; issue quarterly reforecasts with variance narratives. • Evaluate and implement an FP&A platform, integrated with QBO and providing department-level visibility. • Own the quarterly board finance package - standardized KPIs, variance analysis, and cash runway narrative - and provide regular financial updates to executive leadership and the board. • Populate data rooms, respond to investor and lender diligence requests, and prepare financial packages for capital partners. Support venture debt facilities and future financing events. • Partner with leadership on pre-board alignment, narrative framing, and capital strategy. Over time, assume primary ownership of investor-facing finance communications. • Build and manage contract processing workflows, the contract repository, and outside counsel relationships. Oversee vendor management and compliance filings. • Maintain the company's insurance portfolio - D&O, clinical trial liability, general coverage - reviewed annually and updated at financing events. • Manage in-house finance and people team and outsourced service providers. Ensure HR infrastructure is compliant across offer letters, onboarding, benefits, offboarding, and policy maintenance. Ensure payroll runs accurately across multiple states with equity compensation tracked correctly. • Lead ERP evaluation and migration when the company outgrows QBO.

• Authoring and reviewing regulatory submissions, including INAD filings, study reports, clinical trial evaluability meetings, and agency correspondence • Leading preparation for FDA CVM meetings, including  briefing documents, meeting requests, posing questions, and follow-up MOCs • Partnering with clinical teams to provide real-time regulatory guidance on active studies, including SAE submissions, BIMO preparedness, and NCIE reports • Reviewing and preparing study protocols, ICFs, and amendments to ensure the highest quality submissions for pivotal protocol concurrence • Monitoring and interpreting CVM guidance, policy updates, and precedent to inform Loyal's regulatory strategy across our pipeline • Anticipating and resolving regulatory risks across functions (including R&D, CMC, and commercial) throughout the portfolio before they become problems • Managing and mentoring 1–2 direct reports, providing feedback, priorities, and development support • Collaborating cross-functionally with R&D, clinical development, clinical operations, data management, and legal teams on submissions and strategy • Oversee the maintenance and organization of all regulatory records and interactions related to Loyal’s drug programs • Serving as the internal subject matter expert for any question touching FDA CVM clinical requirements — from study design to labeling to adverse event reporting  • Reviewing and advising on external facing pre-approval communications and activities to ensure compliance with FDA CVM regulations • Reviewing and providing guidance on labeling materials for submission to ensure compliance with FDA CVM regulations

• Own and drive Loyal's overall regulatory strategy across all active programs, including integrated CMC and clinical regulatory plans aligned with development milestones and commercial objectives, from early development through approval and post approval lifecycle management. • Provide regulatory input into portfolio planning, program prioritization, and business development activities, ensuring regulatory feasibility and risk are embedded in key decisions. • Develop and maintain global regulatory intelligence capabilities, monitoring evolving agency expectations, guidance documents, and industry precedents relevant to Loyal's programs and translating these into actionable strategy. • Provide regular regulatory updates and risk assessments to executive leadership and the board on submission progress, agency interactions, and regulatory risk. • Lead all CMC regulatory activities including filing strategy, CMC section authorship and review, post approval CMC change management, and regulatory oversight of manufacturing and CDMO partners. • Ensure CMC regulatory strategy reflects current agency expectations for small molecule OSD products and is integrated with CMC development plans and manufacturing timelines. • Partner with CMC and Quality leadership on CDMO regulatory readiness, including preparation for pre approval inspections and CMC related agency interactions. • Lead clinical regulatory activities including IND strategy and management, protocol regulatory review, study report oversight, and integration of clinical data into regulatory submissions. • Oversee regulatory strategy for pivotal studies and ensure alignment between study design, endpoints, and agency expectations to support a strong approval package. • Own the approval submission strategy and execution, coordinating across CMC, Clinical, and Quality to ensure submission ready packages that reflect current agency expectations and eCTD standards. • Serve as the company's primary liaison with regulatory agencies globally, leading the planning and execution of pre submission meetings, formal submissions, and ongoing agency communications. • Manage post approval regulatory obligations including periodic reports, labeling updates, post approval study commitments, and CMC variation filings, ensuring ongoing compliance with approval conditions. • Own labeling strategy and content development across the product lifecycle, ensuring labeling reflects agency requirements, clinical data, and commercial considerations, and is maintained in compliance with post approval obligations. • Establish and own Loyal's regulatory information management infrastructure, eCTD publishing capability, and submission archiving standards. • Build and lead a high performing regulatory organization, establishing clear functional ownership across CMC regulatory, clinical regulatory, submissions management, labeling, and regulatory operations. • Establish and scale regulatory governance frameworks and regulatory procedural documents — including submission templates, agency meeting management procedures, labeling review workflows, and regulatory decision documentation standards — that meet eCTD and global filing requirements and scale with the organization's growth. • Serve as the company's independent regulatory authority, with clear accountability to escalate regulatory risks, flag compliance concerns, and advise on activities where regulatory risk warrants executive attention. • Foster a culture of regulatory excellence and proactive risk management across the organization.

• Build, own, and continuously improve Loyal's CMC quality management system: SOPs, document control, change control, deviation management, CAPA, and risk management processes; ensure systems are fit for purpose now and scalable through commercial launch • Serve as the primary QA point of contact for CDMOs, contract testing laboratories, and key raw material and excipient suppliers, lead qualification, audit execution, and ongoing quality oversight of all external partners • Negotiate, draft, and maintain quality agreements with CDMOs and contract testing laboratories; drive timely execution and hold partners accountable to commitments • Plan and conduct routine GMP audits of CDMOs and suppliers; own audit finding responses and track CAPAs to closure • Lead batch disposition decisions for clinical and development batches; ensure complete, audit-ready documentation packages and timely release • Review and approve analytical method validation protocols and reports, stability protocols and data, executed batch records, CoAs, and CoCs • Oversee deviation and OOS management originating from external partners through to closure • Execute PAI readiness activities including quality systems documentation, validation packages, and site readiness; serve as QA lead during FDA inspections and agency interactions related to CMC • Partner with Regulatory Affairs and CMC teams to ensure quality considerations are incorporated into program decisions, technical transfers, and filing activities; support QA input into NDA and other regulatory submissions • Provide QA oversight of all tech transfer activities — site qualification, process comparability, transfer protocols, and batch record development • Own the Annual Product Review (APR/PQR) process and QA sign-off on labeling for clinical and commercial supply • Define, track, and report CMC QA KPIs: CDMO performance, CAPA cycle times, deviation trends, audit findings, quality agreement status, and batch disposition timelines; use metrics to drive external partner accountability and surface risks proactively to leadership • Apply formal quality risk management principles (ICH Q9) across manufacturing and development activities • Build quality infrastructure that supports the transition from clinical to commercial supply, including commercial batch release processes, post-approval change management, and commercial QMS requirements • Balance compliance requirements with the practical realities of a fast-moving startup environment

• Set and execute the analytical development and QC strategy aligned with Loyal's CMC objectives, resubmission timeline, and PAI readiness • Own the end-to-end analytical and QC lifecycle from early development through commercialization, including method development and validation, commercial QC readiness, product release, stability programs, and post-approval lifecycle management • Author and review analytical sections of regulatory submissions, including CTD modules, NADA/resubmission CMC sections, responses to agency observations, and amendments; this person writes, not just reviews • Lead cross-functional identification and lifecycle management of CQAs, specifications, and control strategies for drug substance and drug product • Lead the development, validation, transfer, and lifecycle management of analytical methods with immediate focus on small molecule OSD, while supporting additional modalities as the pipeline evolves • Own method transfers from development to QC and from internal to contract testing laboratories; ensure methods are robust, transfer-ready, and fit for GMP use • Qualify, manage, and govern contract testing laboratories, including identifying and qualifying alternative testing labs to ensure capability and capacity are not single-source dependent • Ensure contract lab reference standard oversight is governed appropriately, including qualification, traceability, and lifecycle management at external partners • Serve as the accountable leader for GMP analytical and QC operations, ensuring inspection-ready systems and sustained regulatory compliance; own PAI readiness for all analytical and QC activities • Establish and oversee commercial QC operations, including governance of external GMP testing laboratories and service providers • Provide oversight of deviations, investigations, OOS/OOT events, change control, and CAPAs related to analytical and QC activities • Serve as the senior analytical subject matter expert in interactions with FDA CVM and other global animal health regulatory agencies, including regulatory submissions, responses, and inspections • Act as a senior CMC leader on cross-functional program teams, influencing development strategy, timelines, and investment decisions • Build, scale, and lead a high-performing AD and QC organization, including hiring, mentoring, and developing senior technical staff • Own and oversee analytical data systems, ensuring data integrity, 21 CFR Part 11 compliance, and robust digital infrastructure across internal and external partners • Manage resource planning, aligning analytical and QC investments with pipeline priorities and business objectives

• Independently manage the full sales cycle from prospecting through close for deals in the $150K–$800K ARR range. • Own client/prospect relationships, navigating multiple stakeholders and high-level conversations confidently. • Apply in-depth knowledge of Loyal’s products to strategically address customer needs across functions and industry verticals. • Define decision-makers and budget parameters, and prioritize the highest-value opportunities. • Proactively communicate customer needs, market intelligence, and industry insights to internal teams. • Collaborate cross-functionally, bringing the right stakeholders into the sales cycle and supporting internal teams as needed. • Develop and deliver tailored sales presentations, proposals, and business cases. • Maintain accurate CRM records and provide reliable pipeline forecasting. • Mentor junior sales team members by sharing knowledge and best practices.

Loyal is an organization centered on experience and building a platform that allows consumers to make meaningful decisions when it comes to healthcare. We deeply understand providers, locations, services, appointments, business rules, and moreover, we understand patients -- who they are, the preferred method of communication, upcoming appointments, lapsed appointments, outstanding bills, health risks, and more. With this intelligence, our platform fuels highly relevant and personalized experiences across all mediums (website, email, voice…) allowing patients to get healthy, stay healthy, and have a better relationship with the health care provider. Summary We are seeking a dynamic Strategic Account Manager to join our Customer Success team and drive meaningful, lasting partnerships with health system customers while demonstrating the measurable value of Loyal's platform. In this pivotal role, you will own customer strategy, achieve a 95% Revenue Retention target within your book of business, and serve as the primary liaison between key accounts and Loyal's internal teams — directly contributing to Loyal's growth, product stickiness, and customer satisfaction. The ideal Strategic Account Manager is a relationship-driven strategic thinker who goes beyond customer expectations to deliver real outcomes, and brings 3–5 years of experience in strategic account management or full-cycle sales within a SaaS or healthcare environment. You will report to our Chief Operating Officer and collaborate closely with Sales, Implementation, Product, and Marketing teams. This role offers the opportunity to serve as a trusted advisor to executive stakeholders at leading health systems while making a meaningful impact on how healthcare organizations engage with their patients. If you're passionate about healthcare technology and ready to build the deep partnerships that transform customer relationships into long-term growth, we'd love to hear from you. The Strategic Account Manager is responsible for demonstrating the value of Loyal’s platform and products to their customers and achieving a Revenue Retention target of 95% within their book of business, by: - Coordinating with Loyal’s Implementation team and the customer during the implementation phase to collect customer’s baseline data and launch the solution on time - Baselining customer performance before using Loyal solutions and tracking improvements in the performance of Loyal’s solutions throughout the partnership - Reporting on and gaining buy-in on success from multiple stakeholders (inclusive of executive stakeholders) - Recommending strategies to increase the usage and stickiness of Loyal’s products - Identifying new opportunities across the customer organization to implement Loyal products - Understanding stakeholder opinions of Loyal and executing on strategies to move customer stakeholders from unknown, detractor or passive status to promoter status on the People Map You will: Revenue Retention & Account Ownership - Owns a Revenue Retention goal of 95% within their book of business - Maintains a thorough understanding of contractual obligations and ensures 100% adherence to all commitments made by Loyal Relationship Management - Serves as the primary liaison for key accounts, building strong, long-term relationships with executives and key stakeholders through: - Weekly touchpoints with each key stakeholder outside of regularly scheduled meetings - Personalized outreach (cards, notes) to celebrate birthdays, anniversaries, promotions, and other milestones - Quarterly in-person visits, with a preference for connecting every six to eight weeks - Maintaining a minimum of 50% live interactions (in-person or by phone) versus asynchronous communication - Builds and maintains people maps, cultivating relationships both laterally and vertically within customer organizations - Keeps the Loyal Health executive sponsor informed and fully prepared ahead of all customer-facing meetings Customer Strategy & Value Delivery - Partners with Sales to understand customer goals, motivations for partnering with Loyal, and expected contract outcomes; leads the external kick-off meeting with the customer team - Collaborates with customers and Sales to define value metrics (e.g., time to value, usage, ROI); regularly reports on key metrics with strategic interpretation and actionable recommendations - Executes Loyal's standardized discovery process, identifying customer pain points and surfacing cross-sell and upsell opportunities for the Sales team Account Health & Risk Management - Maintains and regularly updates the Customer Health Scorecard; proactively flags changes in account health to leadership and collaborates on risk mitigation strategies - Serves as the internal expert on each account by proactively monitoring customer news and keeping the account team informed of shifting priorities - Responds to customer questions post-onboarding, triages complex issues through Loyal's Customer Support ticketing process, and ensures each interaction adds value Growth & Market Presence - Builds referenceability and actively solicits referrals from key stakeholders to internal and external prospects - Partners with Marketing to coordinate customer participation in testimonials, case studies, and white papers, amplifying the customer voice in the marketplace You have: - Bachelor’s degree in Business, Healthcare, or related field or equivalent work experience - Experience in digital healthcare and/or specifically with hospitals or health systems. - 5 years of experience in full-cycle strategic enterprise account management. - Proven track record of maintaining and growing customer relationships. - Experience working within a software-as-a-service (SaaS) company - Experience working within a high-growth and/or ambiguous environment, with proven experience to be dynamic Knowledge and Skills - Team Leadership & Development: Mentors junior team members on Loyal's operations and product expertise; coaches team on effective customer management techniques and project management methodologies; shares relationship-building best practices and strategic tactics; trains team members on risk management practices and ROI demonstration; develops training materials for complex product features; leads cross-functional project teams to achieve objectives. - Customer Advocacy & Strategic Support: Advocates for customer needs in internal strategy discussions; serves as liaison between customers and product development team; knows when to involve Product partners in client conversations; provides advanced technical support for product usage; develops custom success plans for all accounts; advises customers on optimizing product usage; conducts periodic business reviews with key customers; manages escalations and resolves conflicts effectively. - Market Intelligence & Thought Leadership: Analyzes industry trends to provide strategic insights to clients; identifies opportunities based on industry shifts; offers strategic advice based on deep market knowledge; engages in thought leadership by sharing insights internally; serves as product expert in external and internal meetings; analyzes customer data to suggest product optimization ideas; develops reports aligning customer usage with business outcomes. - Relationship Management & Partnerships: Builds strategic alliances with key stakeholders in customer organizations; facilitates partnerships that enhance customer value; guides team in effective relationship management strategies; knows when to provide immediate answers versus when to research and follow up; maintains professional boundaries while building trust; ensures smooth communication between all parties. - Strategic Problem-Solving & Innovation: Develops creative solutions for unique and complex customer situations; uses data analytics to inform decision-making; evaluates and adjusts strategies based on feedback and results; champions initiatives encouraging experimentation and innovation; mentors team through creative problem-solving processes; accurately articulates problems before developing solutions. - Risk Assessment & Prioritization: Leads risk assessment initiatives for key accounts; develops frameworks for prioritizing customer issues; identifies and mitigates risks to customer satisfaction; establishes protocols for escalating critical issues; analyzes outcomes of escalated issues for continuous improvement; balances multiple projects and priorities effectively. - Value Realization & Growth: Creates customized value assessments tailored to customer goals; builds and shares customer success stories for influence and marketing; develops case studies demonstrating significant ROI; develops strategic plans for upselling and cross-selling; uses customer data to present compelling business cases for additional purchases; participates in negotiations for expansion opportunities; analyzes market trends to identify new opportunities for customers. Core Competencies - Advocacy and Collaboration: Promoting alignment, collaboration, and shared goals across teams and departments. - Constructive Communication: Providing clear, actionable feedback and fostering open, two-way communication. - Operational Excellence: Driving consistent, high-quality results by adhering to best practices and measurable standards. - Professional Integrity: Demonstrating accountability, ethics, and reliability in all interactions and deliverables. - Curiosity and Critical Thinking: Asks insightful questions, challenges assumptions, and demonstrates curiosity about team and user challenges. Drives deeper investigation and focuses on finding the right answers. - Feedback and Adaptability: Actively seeks, gives, and incorporates feedback constructively. Demonstrates a growth mindset by adjusting behaviors and approaches to improve outcomes Physical Demands This job operated in a professional remote or in-office environment. This job uses standard office equipment, such as computers and phones. This job is largely a sedentary role; however, the employee has the flexibility to move as needed. Constantly operates a computer, phone, keyboard, mouse, and other office productivity machinery. The employee frequently communicates with internal and/or external customers and co-workers. Must be able to exchange accurate information. Must be able to recognize objects from short and long distances. Pay Transparency Certain states and localities require employers to post a reasonable estimate of salary range. A reasonable estimate of the current base salary range for this position is $80,000 - $110,000. Actual salary will be based on a variety of factors, including location, experience, skill set, performance, licensure and certification, and business needs. The range for this position in other geographic locations may differ. In addition, certain roles also have the opportunity to earn sales incentives based on revenue or utilization, depending on the terms of the plan and the employee’s role. #LI-REMOTE 🏆 Benefits and Perks We believe in a work/life balance that fulfills you while you’re here and supports you when you’re not. We built our benefits package to prove that we’re committed to you having everything you need (including a little fun). Here is what we offer full-time employees: - Comprehensive health, dental, and vision insurance plans with HSA/FSA options - Flexible PTO, sick, and personal days - Company paid holiday week between Christmas and New Year's! - $50 Monthly Internet Stipend - Long-term & short-term disability - 401[k] plan - Stock Options - Bonus Program - Generous Paid Parental Leave Our Commitment We believe that the key to Loyal's success is you. Your unique background, life experience, knowledge, self-expression, and talent make you uniquely you. Who you are, what you have experienced, and how you think inspires us to be innovative and bold. Loyal is an equal opportunity employer. We hire great people from a wide variety of backgrounds, not just because it's the right thing to do, but because it makes our company stronger. We welcome the unique contributions that you can bring in terms of your education, opinions, culture, ethnicity, race, ancestry, sex, gender identity and expression, national origin, citizenship, marital status, age, languages spoken, veteran status, color, religion, disability, sexual orientation, and beliefs. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Further, consistent with applicable federal and state law, Loyal provides reasonable accommodations when requested by qualified applicants or employees with disabilities, unless doing so would cause an undue hardship. Loyal’s policy regarding requests for reasonable accommodation applies to all aspects of employment, including the application process. If you require a reasonable accommodation in connection with the application process, please contact the People Department at people@loyalhealth.com E-Verify This employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue before the employer can take any action against you, including terminating your employment. Employers can only use E-Verify once you have accepted a job offer and completed the I-9 Form. 🚩 Notice - Employment Scams Communication from our team regarding job opportunities will only be made by an Owner team member with an @owner.com email address. We do not conduct interviews over email or chat platforms, and we will never ask you to provide personal or financial information such as your mailing address, social security number, credit card numbers or banking information. If you believe you are being contacted by scammer, please mark the communication as "phishing" or “spam” and do not respond.

• Owns a Revenue Retention goal of 95% within their book of business • Serves as the primary liaison for key accounts, building strong, long-term relationships with executives and key stakeholders • Partners with Sales to understand customer goals, motivations for partnering with Loyal, and expected contract outcomes • Maintains and regularly updates the Customer Health Scorecard; proactively flags changes in account health to leadership and collaborates on risk mitigation strategies • Builds referenceability and actively solicits referrals from key stakeholders to internal and external prospects

• Lead and continuously advance Loyal’s enterprise-wide GxP Quality Management System, ensuring compliance across GMP, GLP, and GCP domains. • Drive sustained inspection readiness, including strategic preparation for FDA CVM Pre-Approval Inspections (PAIs) and other global regulatory inspections. • Provide executive oversight of GCP quality systems, including clinical trial governance, CRO oversight, TMF compliance, protocol adherence, vendor qualification, and audit readiness for active and future studies. • Ensure robust GMP oversight across CMC development, manufacturing partners, testing laboratories, and commercial supply activities. • Oversee GLP compliance for pivotal laboratory-based studies and CROs. • Lead enterprise audit strategy, including internal audits, supplier audits, clinical site audits, and mock regulatory inspections. • Establish and maintain quality agreements and oversight frameworks for CDMOs, CROs, testing laboratories, and other GxP vendors. • Provide executive oversight of deviations, investigations, CAPAs, change controls, and risk management processes to ensure timely and defensible resolution. • Develop and monitor quality metrics and dashboards to provide executive visibility into compliance performance and organizational risk. • Serve as the primary quality representative during regulatory inspections and interactions with FDA CVM and other global animal health authorities. • Recruit, build, and lead a high-performing QA organization with scalable governance structures and clear accountability. • Foster a proactive, risk-based quality culture that supports operational agility while maintaining regulatory rigor.