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Mirum Pharmaceuticals

3 open positions available

3 locations
1 employment type
Actively hiring
Full-time

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Senior Manager, Compliance Operations & Analytics

Mirum PharmaceuticalsFoster City, CaliforniaFull-time
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Compensation$85K - 130K a year

Lead global healthcare compliance programs using analytics and AI tools to improve monitoring and reporting. | Bachelor's degree with 5+ years in healthcare compliance or analytics in biotech/pharma and experience with Sunshine Act reporting and data visualization tools. | 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, Compliance Operations & Analytics is responsible for supporting the strategic development, implementation, and ongoing enhancement of Mirum’s global healthcare compliance program. This role partners cross-functionally across Commercial, Medical Affairs, Market Access, Legal, Finance, Privacy, and IT to help ensure the Company meets its ethical and legal obligations to patients, healthcare professionals, employees, investors, and other stakeholders. This position will lead operational aspects of the compliance program with a strong focus on compliance analytics, open payments and transparency reporting, auditing, and technology-enabled process improvement. The role will be responsible for overseeing federal and state transparency reporting operations, advancing data analytics and monitoring capabilities, and leveraging AI-enabled tools and automation to improve compliance efficiency, insights, and scalability in a growing biotech environment. The ideal candidate is a proactive and business-oriented compliance professional with demonstrated experience building scalable compliance operations and analytic tools within a small to mid-size biotechnology or pharmaceutical company. JOB FUNCTIONS/RESPONSIBILITIES Compliance Operations and Program Management Support the ongoing development, implementation, and continuous improvement of Mirum’s comprehensive healthcare compliance program. Assist in the design, enhancement, and operationalization of compliance policies, SOPs, standards, and controls aligned with applicable federal and state healthcare laws, regulations, and industry guidance. Partner with Commercial, Medical Affairs, Market Access, Patient Services, and other business functions to provide practical, risk-based compliance guidance. Champion a culture of integrity and accountability in which employees view compliance as aligned with Mirum’s core values and business objectives. Support compliance committee activities, risk assessments, and remediation tracking. Assist with management of third-party compliance due diligence and monitoring activities. Transparency Reporting Ownership Lead operational execution and ongoing enhancement of Federal Open Payments (Sunshine Act) and applicable state transparency reporting processes. Serve as the primary business owner for transparency reporting operations, including data governance, reconciliation, issue resolution, aggregate spend validation, and cross-functional coordination. Partner with Finance, Commercial Operations, Medical Affairs, and vendors to ensure accurate and timely data collection and reporting. Oversee pre-submission review, dispute resolution support, and post-submission reconciliation activities. Monitor evolving transparency reporting regulations and assess and update business process impacts as needed. Drive process improvements and automation initiatives to strengthen reporting accuracy, efficiency, and audit readiness. Compliance Analytics & Monitoring Design, develop, and execute risk-based compliance monitoring and analytics programs using internal and external data sources. Conduct compliance audit activities to identify opportunities for field ride-alongs, speaker program reviews, medical congress audits, expense monitoring, and targeted transactional reviews. Develop dashboards, KPIs, trend analyses, and reporting metrics to identify potential compliance risks and inform leadership decision-making. Partner with business stakeholders to develop corrective action plans and monitor remediation activities. Assess audit and monitoring outcomes and develop and maintain resources to further mitigate risk and address concerns. Support internal investigations, audits, and monitoring initiatives as needed. AI, Technology & Process Innovation Evaluate and implement technology-enabled compliance solutions, including AI-assisted monitoring, analytics, workflow automation, and reporting tools. Utilize AI and data analytics to proactively identify trends that may assist in developing future audit/monitoring plans. Partner with IT, Legal, Privacy, and business stakeholders to assess appropriate governance and controls for the use of AI within compliance-related processes. Support development of governance frameworks and policies related to responsible AI use, data privacy, and compliance oversight. Stay informed on emerging industry trends and best practices related to AI-enabled compliance operations. QUALIFICATIONS Education /Experience: Bachelor’s degree required; advanced degree (JD, MBA, MPH, MS, or equivalent) preferred. 5+ years of healthcare compliance, compliance operations, audit, analytics, or related experience within the biotechnology, pharmaceutical, or life sciences industry. Experience within a small to mid-size biotechnology organization strongly preferred. Demonstrated experience supporting or leading operational aspects of a healthcare compliance program. Strong knowledge of applicable healthcare compliance laws and regulations, including the Anti-Kickback Statute, PhRMA Code, FDA promotional requirements, Open Payments/Sunshine Act, state transparency laws, and related compliance obligations. Direct experience managing or overseeing Sunshine Act/Open Payments and state transparency reporting operations required. Experience developing and executing compliance monitoring, auditing, and analytics programs/dashboards. Experience leveraging data analytics, reporting tools, and visualization platforms (e.g., Power BI, Tableau, Excel, SQL, or similar tools) required. Experience implementing or utilizing AI-enabled compliance tools, automation platforms, or advanced analytics solutions preferred. Experience collaborating cross-functionally with Commercial, Medical Affairs, Finance, Legal, IT, and other stakeholders. Rare disease and/or specialty pharmaceutical experience preferred. Knowledge, Skills & Abilities Strong analytical mindset with the ability to interpret complex data sets and translate findings into actionable business recommendations. Demonstrated ability to build scalable compliance operations and processes in a fast-paced, growth-oriented environment. Strong understanding of compliance analytics methodologies, data governance principles, and risk-based monitoring approaches. Ability to evaluate emerging technologies, including AI-enabled solutions, and apply them appropriately within a regulated environment. Excellent interpersonal skills with the ability to build trusted relationships across all levels of the organization. Business-oriented and solutions-focused approach to complex databases and associated compliance risk management. Strong project management and organizational skills with the ability to manage multiple priorities simultaneously. Excellent written, verbal, presentation, and communication skills. Strong conflict management, collaboration, and negotiation skills. Ability to work independently while exercising sound judgment and attention to detail. High level of professionalism, integrity, discretion, and accountability. Ability to influence without direct authority and effectively partner across functions. The salary range for this position is $175,000 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.

Compliance Analytics
Project Management
Risk Management
Direct Apply
Posted 14 days ago
Mirum Pharmaceuticals

Associate Director, Global Medical Communications New

Mirum PharmaceuticalsFoster City, CAFull-time
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Compensation$190K - 210K a year

Develop and manage medical communications materials and initiatives supporting rare disease treatments. | Requires advanced degree and 5+ years pharmaceutical industry experience in Medical Affairs or Communications. | Foster City 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 Associate Director of Global Medical Communications for the LIVMARLI/Bile Acid Portfolio Global Medical Affairs Team (GMAT) is a critical team role with a high-level of accountability, reporting to the GMAT Lead. This role will focus on developing and executing GMAT materials and initiatives, including development, approval, and roll-out of Field Medical Materials; creation of content for and execution of Medical Advisory Boards; and creation of content for and execution of Scientific Symposia and other Medical Education initiatives. The Associate Director of Medical Communications will collaborate with external Medical Communications agencies and Medical Education partners to create timely, relevant, accurate, and engaging tools and programs that support Mirum scientific and medical objectives. They will also collaborate in the management of the database of Medical Field tools, including updating, archiving, and tracking of existing materials, and strategic planning and development of new tools based on needs and objectives of the GMAT. Essential to this role is the ability to effectively communicate and work with internal stakeholders and external thought leaders in a fast-paced environment. JOB FUNCTIONS/RESPONSIBILITIES • Develop and update Field Medical Materials, materials for Medical Advisory Boards, and materials for Scientific Symposia and other Medical Education initiatives independently or with guidance • Ensure all Medical Materials are timely, relevant, accurate, and engaging; are consistent with Mirum scientific and medical objectives; and meet appropriate Regulatory and Compliance standards for the intended use and audience • Collaborate in the management of the database of Medical Field tools, including updating, archiving, and tracking of existing materials and strategic planning and development of new tools based on needs and objectives of the Medical Team • Manage Medical, Legal, and Regulatory (MLR) Committee submission and review of Medical Materials • Organize Medical Advisory Board meetings including operational planning for advisory boards (contracting with advisors, approving FMV honoraria, securing venue, travel, etc.) • Plan and execute scientific/medical education (non-CME) such as: Scientific Symposia at congresses or web-based education, medical education content at congress booths, or other medical education activities • Engage internal and external subject matter experts, when appropriate, for participation in Medical Communications or Medical Education activities and content development • Assist with the creation of other scientific documents (e.g., medical science liaison [MSL] training slide decks, training tools, and FAQs) • Ensure Medical Communications initiatives and tactics are executed within agreed upon timeline and budget • Support commercial team on various tactics (e.g. Brand Plan and commercial materials) QUALIFICATIONS Education /Experience: • Advanced degree (i.e. PharmD, MD, PhD, RN, MS/MA) from an accredited university/program • 5+ years of experience of pharmaceutical industry experience, preferably in Medical Affairs, MSL, and/or Medical Communications experience in an agency or pharmaceutical environment with transferable skill set • Pharmaceutical industry fellowship within Medical Affairs or Medical Communications may satisfy experience requirement • Experience working with cross-functional stakeholders and/or agencies to develop medical field materials/tools • Experience in liver disease or rare disease desired • Experience managing vendors and budgets desired Knowledge, Skills and Abilities: • Advanced computer and Internet skills, including knowledge of Word, PowerPoint, Excel, Veeva Systems, search engines (PubMed, etc.), references databases (e.g., EndNote, Reference Manager), etc. • Proficiency with Microsoft PowerPoint is essential • Knowledge and proficiency in Veeva Vault and Veeva CRM is strongly desired • Working knowledge of regulations which guide promotional and non-promotional activities of pharmaceutical companies, and experience with their application • Excellent and effective interpersonal and communication skills • Must be well-organized and able to multi-task in a fast-paced, deadline-driven environment • Ability to interact with internal stakeholders (i.e. commercial, clinical operations, statistics, regulatory, publications, etc.) and coordinate on appropriate scientific and medical activities as they relate to on-going medical affairs projects • Ability to work independently with some supervision and guidance • Ability to travel (US and International) approximately 25% of time The salary range for this position is $190,000 to $210,000 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. 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.

Medical Communications
Stakeholder Collaboration
Project Management
Verified Source
Posted 3 months ago
MP

Associate Director Marketing Thought Leader Liaison, West

Mirum PharmaceuticalsAnywhereFull-time
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Compensation$120K - 200K a year

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.

KOL engagement
Strategic thinking
Project management
Market data analysis
MS Office (Word, PowerPoint, Outlook)
Pharmaceutical industry knowledge
Hepatology/Gastroenterology expertise
Direct Apply
Posted 11 months ago

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