Mirum Pharmaceuticals

Leading regulatory CMC strategies and submissions for biopharmaceutical products. | Over 12 years of experience in Regulatory Affairs CMC, with expertise in small molecules and biologics, and successful regulatory submissions. | MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. POSTION SUMMARY The Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will provide strategic and operational leadership, and who will ensure the effectiveness of the Regulatory Affairs CMC team within the Regulatory Affairs department and across the organization. The position will be responsible for all CMC-related submissions: strategic planning, execution, and ensuring quality and accurate supporting documents are submitted within the agreed upon timelines. The ideal candidate will need to be able to accurately interpret and discuss CMC data within cross-functional teams and with Health Authorities. JOB FUNCTIONS/RESPONSIBILITIES Oversees the development and implementation of all regulatory CMC strategies to support market applications, post-marketing CMC commitments, and global development programs across Mirum portfolio. Directly leads the regulatory CMC strategy for assigned projects. Responsible for ensuring the appropriate execution of all regulatory CMC strategies. Actively seeks out knowledge of overall corporate planning, business objectives, and current regulatory requirements to develop regulatory positions for assets in Mirum portfolio, and incorporates this knowledge into submission planning. Ensures the effectiveness of the Regulatory CMC team in developing submissions and in working across functions. Clearly articulates regulatory challenges/risks, identify potential solutions, leads the preparation of risk assessments on regulatory CMC topics, and effectively oversees change controls Builds and manages relationships through active partnering with key internal and external stakeholders. Ensures CMC dossiers meet ICH format and content requirements, as well as specific local requirements of individual countries. Analyzes and exercises judgment on complex issues, guided by a thorough understanding of CMC. Supports regulatory submissions (NDA, MAA, etc.), Briefing Packages, and response documents for Health Authority interactions and address questions/requests, as well as annual updates (e.g., IB, NDA ARs, IND ARs). Previous experience leading CMC discussion during meetings with Health Authorities, and regulatory CMC strategy for small molecule, biologics and orphan/breakthrough programs. Effectively manages direct report(s) and provides mentorship to junior professionals. QUALIFICATIONS Education/Experience: A minimum of 12 years of relevant experience in Regulatory Affairs CMC. Experience in drug development focused on market applications (NDA, sNDA, MAA and variations), investigational applications (INDs, CTAs) and commercial lifecycle. Advanced degree in a relevant scientific discipline required, PhD in chemistry or other relevant scientific field is a plus. Must have experience with small molecules and biologics regulatory CMC activities, late-stage development through commercialization. Combination product experience/knowledge preferred. Demonstrated track record of successful submissions to FDA and/or other Health Authorities, including EMA. Regulatory experience/exposure to Japan and China is a plus, and other regions/countries (e.g., Canada, LATAM, MENA, Australia/NZ) is a plus. Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions. Excellent interpersonal, verbal and written communication skills as well as the ability to effectively partner with and influence others are essential in this collaborative work environment. Outstanding people management and mentorship skills are required. Excellent planning and organizational skills and ability to work simultaneously on multiple projects with tight timelines. Comfortable in a fast-paced, small company environment with minimal direction and able to adjust workload based upon changing priorities. Work Environment: This is a high-growth, fast-paced organization. The ability to be productive and a team player s critical. Ability to work under minimal supervision. Willingness and ability to travel domestically and internationally is required. It is anticipated that this will be 5-10% of work time. The salary range for this position is $280,000 to $310,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided. #LI-HYBRID Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws. Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.

Own and operate Mirum’s Commercial IT integration landscape, ensuring reliable, scalable, and compliant data flows across platforms. | Extensive experience in enterprise integrations, supporting Salesforce, middleware platforms, and regulated industry standards, with leadership in cross-functional teams. | MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. POSITION SUMMARY The Senior Manager, Commercial IT Integration Lead is responsible for owning and operating Mirum’s Commercial IT integration landscape, serving as the enterprise lead for data movement, system connectivity, and integration governance. This role has end-to-end accountability for the stability, scalability, monitoring, and continuous improvement of real-time, event-driven, and batch data flows supporting Salesforce Life Sciences Cloud (SFLC) and the broader Commercial ecosystem. As the Patient CRM platform transitions to steady state, this role will expand to support broader Commercial IT integration strategy and data movement initiatives to strengthen Mirum’s enterprise data foundation. The Senior Manager, Commercial Integration Lead partners closely with the CRM Platform Lead, internal IT teams, business users, and external vendors to ensure integrations and data flows are reliable, scalable, and supportable in a regulated environment. JOB FUNCTIONS/RESPONSIBILITIES Integration Platform Ownership & Leadership Serve as the IT owner for Commercial integrations, with accountability for enterprise integration architecture, standards, and governance. Define and enforce reusable integration patterns, API strategies, data contracts, and architectural guardrails across Commercial systems. Own the reliability, scalability, performance, and resiliency of real-time, event-driven, and batch integrations across Salesforce and external platforms. Partner closely with the CRM Platform Lead to ensure tight alignment between platform configuration, integration design, and data flow behavior. Contribute to long-term Commercial IT integration and data architecture strategy as the ecosystem matures. Integration Operations & Monitoring Establish proactive monitoring, alerting, health metrics, and observability frameworks across all Commercial integrations. Lead incident management, root cause analysis, and remediation for integration failures impacting Patient Services or HCP engagement operations. Design and implement structured error-handling, retry logic, and recovery patterns to minimize business disruption. Oversee integration change management, release coordination, and production support processes. Design, Optimization & Tool Strategy Refine and standardize integration patterns to improve reliability, performance, and ease of troubleshooting, independent of specific tools. Partner with IT leadership to evaluate, select, and recommend integration technologies as business and scalability needs evolve. Support initiatives to centralize and operationalize Commercial data assets, ensuring integration patterns align with enterprise data engineering and warehousing strategies. Ensure integration solutions are operationally supportable, well-documented, and resilient regardless of the underlying platform. Vendor & Cross-Functional Collaboration Work closely with internal IT teams, the SFLC Platform Lead, and external IT vendors to design, implement, and support integrations. Coordinate deployments, production support, and issue resolution across multiple vendors and system owners. Ensure effective knowledge transfer from implementation vendors to internal IT teams for long-term ownership. Governance, Security & Compliance Ensure integrations comply with Mirum’s security, data privacy, and regulatory requirements, including controlled data handling. Support audit readiness by maintaining integration documentation, data flow diagrams, and operational procedures. Implement and enforce governance practices for integration design, change management, and production support. Continuous Improvement & Enablement Identify opportunities to improve automation, observability, and operational efficiency across the integration landscape. Document integration architectures, support processes, and troubleshooting guides to enable consistent operations. Support evolving Commercial IT data needs, enabling scalable data movement and accessibility for reporting, analytics, and operational insight. Stay current with integration best practices and emerging technologies, recommending improvements that reduce risk and manual effort. QUALIFICATIONS Bachelor’s degree in Computer Science, Information Systems, Engineering, or a related field. 6+ years of experience designing and supporting enterprise integrations in complex environments. Proven experience supporting Salesforce integrations across real-time and batch processing models. Hands-on experience with iPaaS or middleware platforms (e.g., Workato, MuleSoft, Informatica, or equivalent). Exposure to enterprise data engineering, data warehousing, or Commercial analytics ecosystems preferred. Experience working in biotech, pharma, or similarly regulated industries strongly preferred. Demonstrated experience working with external vendors and supporting platforms post–implementation. Knowledge, Skills and Abilities: Deep expertise in enterprise integration architecture, including API-led design, event-driven patterns, middleware platforms, and batch processing models. Strong understanding of data governance, master data principles, and integration impacts on analytics and reporting ecosystems. Proven ability to implement observability frameworks, structured error handling, and resilient integration designs in production environments. Experience operating integrations in regulated industries, with awareness of validation principles, audit readiness, and secure data handling practices. Strong troubleshooting and analytical skills in high-availability production environments. Demonstrated leadership and cross-functional collaboration skills, balancing strategic integration roadmap ownership with hands-on operational accountability. The salary range for this position is $190,000 to $205,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided. #LI-HYBRID Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws. Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.

Manage end-to-end global pharmaceutical supply chain activities, including planning, artwork, and compliance, in a fast-paced environment. | Requires 6+ years in pharmaceutical supply chain, experience with CMOs, CPOs, and global distribution, and knowledge of regulatory and artwork management. | MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. POSTION SUMMARY Manage Mirum’s end-to-end commercial supply planning activities for global markets. The successful candidate will demonstrate end-to-end commercial supply chain expertise (including global artwork and labeling & packaging end-to-end process and systems), be able to work independently and enjoy working in a dynamic, complex, fast-paced environment during a period of significant growth and global expansion. This is a highly integrated role that will work cross-functionally partnering with Mirum’s internal functions/SMEs and external partners to ensure supply continuity. JOB FUNCTIONS/RESPONSIBILITIES Manage the end-to-end commercial supply planning and scheduling with Mirum’s CMOs and CPOs (including managing raw materials, material allocations based on jurisdictional control requirements). Own the planning process to ensure supply continuity managing active replenishments to support the future sales forecast while minimizing inventory costs and effectively communicating supply needs within Mirum and to CMOs and CPOs. Own the artwork management process to develop pristine and compliant artwork aligned with approved global labeling and adhering to regulations across the worldwide health authorities/agencies. Partner with Senior Director Commercial Supply Chain to continuously optimize the Global S&OP process. Manage the Global Supply Review (GSR) process specifically ensuring no impact to global supply, closely managing routine manufacturing for API & Drug Product & Packaging. Partner closely with the CMC, Regulatory, and Quality teams to ensure smooth transition from process validation to routine commercial manufacturing. Ensure that CMC is a partner during routine manufacturing to cover all technical manufacturing requirements. Partner with the Supply Chain BPO for the set-up and management of commercial supply chain systems and processes – ensure all elements of drug substance allocation, drug product management, jurisdictional control restrictions, etc. are incorporated in the attributes and master data in Rapid Response Advance Planning System. Support new products and product life cycle management improvements projects as required. Partner with the Supply Chain BPO to draft, formalize and maintain commercial SOPs for manufacturing, jurisdictional control, planning, artwork management etc, as required. Manage and lead supply chain projects & initiatives with artwork, manufacturing and distribution to improve supply flow, inventory costs, and business processes. Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. Support labeling inspection/audit readiness activities Keep abreast of any changes in regulatory requirements that may impact Mirum’s end-to-end manufacturing planning and distribution. QUALIFICATIONS Education/Experience: A./B.S. required. 6+ years of global supply chain or supply chain planning related experiences (including S&OP) in Pharmaceutical / Biotech operations. Experience in working with CMOs, CPOs, 3PLs, vendor and artwork management. Proven understanding of global pharmaceutical distribution requirements (including cold chain) and trade compliance Experience in end-to-end supply chain network, forecasting, inventory management, safety stocks, jurisdictional control and artwork management. Advance planning system experience preferred, i.e., Rapid Response Certification in ASCM CPIM preferred. Demonstration of project management, negotiation, and excellent communication skills or new product supply chain planning experience preferred. Knowledge, Skills and Abilities: Proven ability to manage end-to-end supply planning in a virtual manufacturing environment working with CMOs and CPOs Demonstrates a ‘can-do, agile’ attitude and willing to work in a small, dynamic environment. Proactive, shows good judgement, anticipates future consequences, and can make decisions decisively in the face of ambiguity. Demonstrates understanding of labeling requirements, regulations, and guidance in support of labeling strategies worldwide. Manage through complex product allocation scenarios to support jurisdictional requirements. Creates a sense of partnership with CMOs/CPOs, suppliers, etc. but with direct approach. Demonstrates cross-functional collaborations and teamwork fostering customer focus mind internally and externally. Strong written and oral communication and organizational skills Attention to detail. Thinks outside the box and can come up with creative solutions when faced with challenges. Can prioritize (and quickly re-prioritize as needed) and multi-task. Not afraid to speak up when there is a better way to do something. Has integrity, honesty, conscientiousness, organized, team-oriented and willing to jump in wherever needed. The salary range for this position is $180,000 to $190,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided. #LI-HYBRID Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws. Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.

Assist in preparing SEC filings, ensure compliance with US GAAP and SEC regulations, and support SOX compliance. | CPA certification, 2-3 years in a public company, experience with SEC reporting and technical accounting in biotech or pharma preferred. | MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. POSTION SUMMARY As Senior Manager, SEC Financial Reporting and Technical Accounting, you will be an integral part of the preparation of financial statements in compliance with US GAAP and SEC guidelines, serve as a technical accounting expert and assist in managing the SOX program for the organization. This individual interacts with various levels of management within the accounting/finance organization and third parties across financial and operational projects and initiatives. The ideal candidate is a licensed CPA with extensive biotechnology and/or pharmaceutical experience. This position reports directly to the Executive Director, SEC Reporting & Technical Accounting. JOB FUNCTIONS/RESPONSIBILITIES Assist in the preparation of the quarterly and annual SEC filing on Forms 10-K and 10Q. Compile financial statements and footnote disclosures, as well as assist in analysis for management disclosures and other SEC disclosures. Ensure financial statements are prepared in accordance with US GAAP and SEC regulations, including newly issued accounting pronouncements. Perform technical accounting research as needed on significant or unusual transactions. Assist with ASC 606 revenue recognition matters for the company. Recommend, implement, maintain and communicate accounting policies and procedures to ensure integrity and consistency of application throughout the organization. Responsible for stock-based compensation accounting. Assist with the Company’s 404 SOX compliance program including evaluating the adequacy of controls at existing and proposed new service organizations based on reporting provided by the service organizations. Work with Company’s external SOX partners to ensure timely completion of management testing of controls. Assist with preparation of the annual proxy statement and other ad hoc filings. Prepare supporting schedules for audit committee presentations. Other ad hoc projects as needed. QUALIFICATIONS Education/Experience: Strong US GAAP and compliance experience . Minimum 5 years of progressive accounting experience including 2-3 years in a public company, at a minimum. CPA and Big Four experience auditing biotech companies is strongly preferred. Workiva experience preferred SEC reporting, technical accounting experience, plus operations in a SOX 404(b) environment preferred. Candidate performs with strong sense of urgency and works effectively under deadlines. Attention to detail and ability to multi-task. Strong written and verbal communication skills. Education: Bachelor or master’s degree in accounting CPA required Knowledge, Skills and Abilities: Strong work ethic. Strong analytical skill. Excellent written and verbal communication skills. Self-starter with ability to prioritize workload. Candidate performs with strong sense of urgency and works effectively under deadlines. Attention to detail and ability to multi-task. The salary range for this position is $170,000 to $190,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided. #LI-HYBRID Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws. Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.

Develop and execute strategic plans for engaging key opinion leaders, collaborate with internal teams, manage compliant relationships, and support brand strategy in the pharmaceutical field. | Bachelor’s degree plus 10+ years pharmaceutical experience with 3+ years working with Hepatology/Gastroenterology KOLs, strong strategic, project management, and communication skills, and ability to travel extensively. | MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. POSITION SUMMARY The Thought Leader Liaison (TLL) serves as a key strategic partner between Mirum Pharmaceuticals and the healthcare community, focusing on cultivating and maintaining relationships with key opinion leaders (KOLs), thought leaders, and other external stakeholders. This role is responsible for building scientific credibility, supporting brand strategy, and ensuring aligned, compliant engagement with external experts to enhance awareness and education. Area of focus will be supporting the Mirum IBAT Inhibitor portfolio targeting the Hepatology and Gastroenterology community. JOB FUNCTIONS/RESPONSIBILITIES Develop and communicate the strategic vision and operational plan for engaging KOLs. Develop and oversee development and execution of individual KOL Mapping KOLs plans. Partner closely with the Director, Marketing – KOL Strategy and Congress Planning to ensure alignment. Build and maintain productive, collaborative, and compliant relationships with peers leading teams in Marketing, Market Access, Patient Services, and Medical Affairs. Work closely with the Field Sales team on the execution of all thought leader-related initiatives and programs. Build mechanisms to collect insights, synthesize and integrate them, and communicate to brand to inform tactics Bring thought leaders closer to Mirum by ensuring compliant, value-added connections across the organization. Collaborate with Medical Leadership on engagement strategy and planning as appropriate, including support and coordination of commercial advisory boards. Engage with KOLs to solicit feedback that shapes and informs brand strategy. Contribute Marketing strategy for conferences/congresses including sponsorships, communication/messaging, and advocacy group engagement. Work in partnership with the Marketing portfolio leaders and field leadership to develop appropriate KPIs and metrics to support the brand marketing and executional goals. Act as primary point of contact for the field, maintaining an effective two-way dialogue on KOL engagement, potential speaker identification, and up-and-coming thought leaders and experts. Analyze market data, confirm data reliability and inform team stakeholders to make informed decisions. Proactively engage partners in Legal and Compliance to ensure programs and processes are being delivered with the highest ethical standards QUALIFICATIONS Bachelor’s degree (required) A minimum of 10 years of pharmaceutical or related industry experience required A minimum of 3 years of working with Hepatology/Gastroenterology KOLs preferred Knowledge, Skills and Abilities Strategic thinking and an ability to work in a hands-on manner to deliver on multiple priorities Able to draw insights from a variety of sources, understands market and competition. Compiles relevant data from appropriate sources and performs analysis. Synthesize complex and diverse information, recognizes trends and/or interrelationship. Ability to meet objectives and deadlines, promote efficiency and effectiveness, and incorporate improvements and program return on investment (ROI). Strong project management experience and the ability to manage and coordinate projects with multiple internal stakeholders and vendors on time Excellent verbal, written, organization and interpersonal skills required. Versed in MS Office tools including Word, PowerPoint, and Outlook. TRAVEL Requirements Approximately 65% domestic travel throughout the US. Selected candidate must live near a major airport and be able to travel regularly throughout the assigned area and attend meetings at both Mirum office and off-site locations through the US. #LI-REMOTE Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws. Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.