• 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

• Articulate the value of the Tanium platform to decision makers and expertly manage the complex sales cycle • Nurture and develop relationships within the assigned territory and/or accounts, presenting to the C-suite the value of the Tanium platform • Work with the Partner and Marketing teams to define and support prospecting and sales efforts within assigned territory and/or accounts • Generate appropriate sales development activity to ensure healthy pipeline management • Accurately forecast, maintaining excellent SFDC hygiene • Conduct online webinars or in-person presentations to generate qualified leads • Travel as needed

• Oversee and drive quality performance across payment integrity solutions, ensuring continuous improvement and operational excellence • Collaborate with cross-functional business units to measure, report, and enhance quality performance metrics and outcomes • Develop and align best-in-class quality processes and standards, delivering exceptional results through operational excellence • Work closely with Operations and Product teams to drive quality improvements by leveraging technology, optimizing processes, and developing talent • Ensure timely and accurate responses for Payment Requests for Information (RFIs) and Request for Proposals (RFPs) • Support client intake requests for PrePayment Business Unit by understanding client requirements and providing tailored solutions and cost estimates • Hire, develop, coach, and retain top-tier talent, fostering a culture dedicated to exceptional quality and customer satisfaction • Optimize labor and operating expenses while increasing productivity, service quality, and supporting future client growth • Lead and support operational improvement initiatives encompassing people, processes, and technology to deliver incremental value and operational efficiency, consistently meeting or exceeding service and quality goals • Enforce Cotiviti’s intellectual property protection best practices throughout all operations • Diagnose and resolve issues proactively, manage schedules, and ensure deadlines are met for timely completion of work • Develop short-term and long-term plans to anticipate client needs and operational improvements • Cultivate a positive workplace culture that supports corporate goals, promotes initiative, and fosters open communication at all organizational levels • Collaborate and support business leaders throughout the organization, maintaining highly effective client and team dynamics in a collaborative environment • Manage and delegate team and individual projects/assignments, and review performance against operating plans and standards • Provide comprehensive reports and metrics to drive operational quality and inform strategic decisions, based on operational objectives and work plans at a senior level • Build, maintain and influence strong relationships with executive leadership to support organizational goals

As the leading global type 1 diabetes (T1D) research and advocacy organization, Breakthrough T1D helps make everyday life with T1D better while driving toward cures. We invest in the most promising research to turn ideas into life-changing therapies and devices. We work with government, regulatory officials, and insurance companies to address issues that impact the T1D community -- breaking through barriers that limit access to care worldwide. We provide resources and guidance that makes it easier to live and thrive with T1D. This is more than a moment -- we're empowering a movement for the T1D community. Share your support and help educate and empower individuals facing type 1 diabetes. Our mission is to improve lives today and tomorrow by accelerating life changing breakthroughs to treat, prevent and ultimately, cure T1D and its complications. Always, we are guided by a single purpose: As we drive towards curing type 1 diabetes, we help make everyday life better for the people who face it. The Chapter Director (CD) supports the organizational strategies and mission by serving as the chapter’s primary external affairs officer while building strategic relationships with constituents and donors on behalf of Breakthrough T1D, expanding our reach to support maximum chapter and market penetration. The CD ensures increased efficiency, effectively utilizing core program metrics and key indicators to drive year-over-year trends, goal attainment and maximum performance impact. The CD develops and sustains effective volunteer board in assigned market and leads relationship building with key donors and volunteers. The CD collaborates with Global Development on activities to generate greater revenue and volunteer impact. This individual is a visionary and motivator who effectively brings the mission to life within the community through collaboration, cultivation, inspiration, and engagement. Utilizing exceptional time management skills, they proficiently execute activities that support organizational strategies in the assigned chapter to drive optimal results and actively demonstrate and promote enterprise-wide mindsets. As one of the top performing territories in the country, the Southern States Territory includes Alabama, Arkansas, Louisiana, Mississippi and Tennessee, and plays a vital role in the organization’s success. The territory has 16 staff, 7 Boards, 17+ events, and collectively drives approximately $7 million in total net revenue. The LA Chapter Director is responsible for fundraising in the LA Chapter with events across the state including Baton Rouge and New Orleans. Collaboration with staff, committee members, volunteers, and managing a 15+member LA Chapter local board to raise $800,000 annually through BT1D signature events, including a Gala and P2P campaigns. This is a remote position; however, the ideal candidate is required to reside in Baton Rouge or New Orleans, LA areas. Key Responsibilities Fundraising & Engagement – 50% - Execute strategic revenue plans to drive profitable, diversified, and sustainable year-over-year growth in the chapter. - Assume responsibility for achieving both personal and chapter level revenue goals; and support the achievement of territory revenue goals. - Drives new levels of performance in Peer 2 Peer, Signature Events, individual giving, and constituent relationship management within the chapter. - In collaboration with national and chapter partners, collaborate on annual strategy for corporate engagement, major giving, and stewardship at the chapter level. Identify and develop new business with existing donors and new prospects. Volunteer Management – 25% - Engage and leverage the Community Board in assigned chapter area and ensure the on-going development of a strong and impactful board. - Guide the board nominating process and provide direct support and leadership in attracting and retaining high-impact board members and ensure it represents the community served. - Ensure meaningful engagement of volunteers at all levels and promote good working relationships between staff and volunteer leadership. - Partner with volunteer leadership to solicit funding and other support from individuals, corporations, foundations and other sources of funding and/or influence. Awareness – 15% - Provide leadership for the cultivation of productive relationships with constituents, media, and health care partners to advance brand awareness and mission priorities. - Promote mission engagement opportunities throughout the community in the areas of research, advocacy, and clinical trials. - Support active and growing Community Engagement programs to acquire and activate new families. - Collaborate with territory staff on the engagement of mission-focused volunteer leadership – including Advocacy Team Chairs, Clinical Trial Education Volunteers, and Mission Information Volunteers – to advance the priorities of the organization. Administration and Management – 10% - Provide leadership, performance management and professional staff development and build a strong, cohesive, and collaborative team. - Accountable for the development, management, and attainment of annual budgets, the maintenance of fiscal records, and the timely and accurate submission of Breakthrough T1D financial and forecast reports. - Ensure staff and volunteers adhere to organizational policies and procedures, including annual training and other compliance requirements. - Represent the interests, professionalism, and integrity of Breakthrough T1D in all activities and relationships through a unified message of the Breakthrough T1D mission, and a commitment to organizational standards and leadership by personal example. - Serve as an active member of the Territory Executive Team providing overall leadership, mentoring, and operational direction to ensure cost-effective and efficient systems. Requirements: - 7-10 years of professional fundraising experience, with a clear record of achievement in a complex, mission-driven organization; 5-7 years in a supervisory capacity. College degree or equivalent combination of education and experience. - Record of success in a fundraising leadership role, with revenue responsibilities in excess of $2M; experience working directly or leading staff teams particularly in large scale events (walk, gala, etc.) and major and corporate giving. Strong skills in the identification, cultivation, solicitation, and on-going stewardship of donors and supporters - Experience in partnering with strong and active volunteer leaders, including working successfully with a large network of passionate volunteers. - High degree of energy, integrity, courage, empathy, and creativity. High emotional IQ. Superior active listening, analytical, and critical thinking skills. - Demonstrates the ability to inspire, lead, and motivate teams while fostering an inclusive and respectful work environment through all interactions with staff and volunteers. Exhibits effective delegation skills to enhance both organizational and individual productivity. - Ability to develop and successfully maintain an extensive network of strategic relationships (donors, volunteers, community partners, etc.) in the local area. Existing knowledge and network of relationships in the territory preferred. - Ability to be an enthusiastic spokesperson/representative of Breakthrough T1D’s mission. High level of comfort communicating complex information (e.g., Breakthrough T1D research, goals, etc.) to a wide range of audiences so that they can understand and retain the content. - History of effective performance management that aligns staff efforts with organizational goals. - Proficiency in Salesforce CRM and MS Suite, essential for managing donor relationships and streamlining operations. - Highly efficient in time management and able to meet deadlines under pressure. Ability to travel locally required. Occasional overnight travel as needed. Essential Functions: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools or controls. The employee is occasionally required to stand, walk, sit, reach with hands and arms, climb or balance, and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 25 pounds, and infrequently up to 50 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, and the ability to adjust focus. The noise level in the work environment is usually moderate. Benefits: Breakthrough T1D offers competitive benefits, including medical, dental, and vision coverage, a 403(b) retirement plan, voluntary benefits, flexible spending and commuter benefit accounts, an employee assistance program (EAP), life and disability insurance, performance-based bonuses, and generous paid time off. Benefits may vary by job level and full time or part time status. Additional information: Requests for medical, religious, and other exemptions will be considered on an individual basis. Breakthrough T1D will comply with all federal, state, and local laws. Breakthrough T1D supports a diverse and inclusive workforce. Breakthrough T1D is an Equal Opportunity Employer. All your information will be kept confidential according to EEO guidelines.