POSITION SUMMARY

We are looking for a Senior Director of CMC Project Management who is upbeat, organized, self-motivated, collaborative, detail-oriented, and has a strong technical background and knowledge base.  The person filling this player/coach role will partner with the Head of Tech Ops, Biologics to provide strategic and operational leadership to the brelovitug CMC program, overseeing the development and implementation of integrated CMC plans from PPQ campaigns through global regulatory submission, approval, commercial launch, and lifecycle management activities. This role requires being able to prioritize to meet both short-term and long-term goals. This is a fantastic opportunity to make an impact, wear many hats, and be a part of an exciting growing biotech company.  This position is located in Foster City.

JOB FUNCTIONS/RESPONSIBILITIES

• Manage program CMC budgets and related contracts, partnering with internal Finance and Contract functions.
• Serve as the primary business lead for external partners, ensuring technical transfers,  manufacturing campaigns, testing, and other externally sourced activities stay on schedule and within budget.
• Maintain dashboards and reporting mechanisms for program status, risks, decisions, and critical path updates for team and senior/executive leadership.
• Facilitate cross-functional communications to gather inputs, align priorities, resolve conflicts, and share project updates; ensure clarity of owners, deliverables, and deadlines.
• Maintain an integrated program timeline identifying critical decision points, governance reviews, team events, and key milestones.
• Partner with Program Project Management to ensure appropriate integration with overall product strategy, timelines, and reporting, including alignment between development activities and portfolio-level planning as needed.
• Support preparation for governance reviews and executive program presentations, ensuring materials are accurate, aligned, decision-oriented, and delivered on schedule.
• Drive disciplined change control and documentation of scope/timeline changes, ensuring impacts are understood and communicated to stakeholders.

QUALIFICATIONS

Education /Experience:

• Bachelor’s degree; advanced degree (M.S., Ph.D, or MBA) preferred.
• At least 15+ years of work experience in the pharmaceutical/biotech industry with a significant focus on CMC project management for biologics.
• Experience managing relationships with biologics CDMOs.
• Able to effectively communicate updates, issues, and strategic solutions to problems.
• PMP (Project Management Professional) or equivalent accreditation is desired.

KNOWLEDGE, SKILLS, AND ABILITIES

• Strong interpersonal skills and ability to collaborate across functions; proven ability to influence without authority.
• Strong PM fundamentals (meeting management, timeline/critical path management, risk and issue management, decision tracking, action management, governance preparation).
• Proactive, forward-thinking, and able to anticipate needs in dynamic environments with competing priorities.
• Exceptional facilitation and communication skills (including executive-ready written and presentation skills) with success influencing at all levels cross-functionally.
• Strategic, able to identify long term needs and risks and to incorporate these into a long-term plan. Proven ability to make smart business decisions while balancing scientific, technical, and risk-based factors.
• Highly collaborative with outstanding relationship-building skills; ability to lead teams, navigate ambiguity, and resolve conflict effectively.
• Experience with project/portfolio management tools and systems and strong working knowledge of common collaboration tools (e.g., MS Office, Smartsheet, SharePoint).
• Willing to travel and to participate in teleconferences during non-business hours.

The salary range for this position is $270,000 to $300,000 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.

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POSITION SUMMARY

The Senior Manager, Bioanalytical will be responsible for all aspects of bioanalytical in the development and approval of Mirum rare disease assets.  As a key member of the small Clinical Pharmacology & Nonclinical Sciences group, the individual will represent these multiple functions on multidisciplinary drug development teams to define the strategy and oversee the execution of required studies/analyses through CROs to achieve team goals.

 JOB FUNCTIONS/RESPONSIBILITIES

• Serves as the bioanalytical lead on project and study teams, providing subject matter expertise on clinical development programs
• Leads the design and is responsible for the execution of nonclinical and clinical bioanalytical studies for all Mirum assets
• Manages collaborations with CROs and consultants, providing technical oversight as needed and ensuring timely and quality deliverables to fulfill project goals
• Leads the completion of the relevant sections of IND, NDA, MAA, other regulatory documents and works closely with Regulatory to support clinical document submission
• Provides CROs with technical oversight as needed and ensures that assay development, validations, sample analysis, and data transfers occur at CROs and in-house to meet project goals

QUALIFICATIONS

Education/Experience:

• BS in Biological Sciences and minimum of 6-8 years of relevant experience, or an advanced degree (MS, PhD) with fewer years of experience
• Prior experience with assets in liver, neurology, or rare disease indications is a plus
• Prior hands-on laboratory experience operating LC-MS/MS systems (or other quantitative instrumentation) and conducting sample preparation and analysis

 Knowledge, Skills and Abilities:

• Strong knowledge of GLP/GCLP compliance in supporting nonclinical and clinical studies
• Solid project management skills: ability to create and manage project plans, budgets, and schedules
• Strong communication skills (written and verbal) and interpersonal skills with an ability to communicate to people at all levels of the organization
• Functions efficiently, effectively and at times independently
• Proven track record of success as both an individual contributor and a collaborative team member
• Experience coordinating studies through CROs
• Recognized for being self-directed, well-organized, flexible, and detail-oriented; able to complete multiple activities while maintaining quality

 The salary range for this position is $200,000 to $220,000 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.

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POSITION SUMMARY

We are seeking a detail-oriented and highly organized AP Accountant to join our Accounting Operations team. This role is responsible for the accurate and timely processing of accounts payable transactions, expense reports, vendor communications, and related general accounting activities. The ideal candidate will thrive in a dynamic, complex, and fast-paced environment and possess strong analytical, organizational, customer service and critical thinking skills. This position requires a combination of technical accounting knowledge and operational experience, along with the ability to independently resolve issues, manage multiple priorities, and collaborate effectively across departments. The candidate should be able self-motivated, adaptable, and a strong team player with a solid work ethic. This role regularly interfaces with internal stakeholders and external vendors and plays a critical role in supporting the Finance and Accounting organization within a growing company.

JOB FUNCTIONS/RESPONSIBILITIES

• Responsible for processing high volumes of accounts payable transactions, including invoice entry, account coding, and ensuring proper accounting period entry for accuracy and compliance with company policies.
• Review invoices for appropriate supporting documentation prior to processing and payment.
• Process accounts payable by matching invoices with appropriate purchase orders and supporting documentation.
• Review vendor contracts and exercise judgment in assigning appropriate expense accounts, departments, and project coding for non-PO invoices.
• Research and resolve vendor account, invoice, and payment discrepancies while maintaining accounts payable in good standing.
• Manage and monitor the AP email inbox, including responding to vendor inquiries, payment requests, and invoice related questions.
• Ensure adherence to company signature authority and approval policies.
• Manage the Concur expense reporting system, including expense report processing, audits and user support.
• Review employee expense reports thoroughly to ensure compliance with company policies and procedures.
• Review expense reports containing Healthcare Professional (HCP) related expenses to ensure Sunshine Act compliance.
• Manage the expense reports email inbox and provide support for employee expense submissions and travel booking inquiries.
• Provide excellent customer service to internal stakeholders and external vendors.
• Support quarterly reviews and annual audit by providing requested documentation to auditors.
• System maintenance for tax reporting compliance and year-end processing of 1099’s.
• Support financial systems implementations and participate in process improvements.
• Assist on special projects and ad-hoc assignments as needed.
• Adapt to evolving responsibilities and business needs within a growing organization.

QUALIFICATIONS

Education /Experience:

• Bachelor’s degree in Accounting, Finance, or related field preferred.
• 5+ years of Accounts Payable or general accounting experience, preferably in a high-volume environment.
• Required experience with Concur expense management system and NetSuite ERP system.
• Strong understanding of AP processes, expense reporting, and internal controls.
• Knowledge of 1099 reporting requirements and audit support processes.
• Proficient in Microsoft Office applications, particularly Excel.
• Familiarity with Sunshine Act compliance is preferred.

Knowledge, Skills and Abilities:

• Strong analytical, problem solving, and critical thinking skills with the ability to exercise sound judgment.
• Strong verbal and written communication skills.
• Ability to work independently to complete tasks in an accurate and timely manner while managing multiple priorities in a fast-paced environment.
• Highly organized, detail-oriented, dependable, and committed to producing accurate, high-quality work.
• Positive attitude, team-oriented mindset, and willingness to adapt to changing priorities and responsibilities.
• Customer-service oriented with the ability to work collaboratively across departments and with external vendors.
• Ability to prioritize tasks effectively and seek guidance when needed.

The salary range for this position is $115,000 to $130,000USD. 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.

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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.

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POSITION SUMMARY

Mirum Pharmaceuticals is a rare disease company with a growing portfolio of innovative therapies and a robust pipeline, Mirum is committed to improving the lives of patients who often face limited treatment options and complex care journeys.

We operate with a deep sense of purpose and urgency—grounded in our values: Care. Have Fun. Be Real. Get it Done. As we continue to scale, market access plays a critical role in ensuring that innovation translates into real-world patient access.  The Senior Director of U.S. Market Access will:

• Shape and elevate U.S. market access strategy to drive optimal coverage, pricing, and patient access across the existing portfolio and future assets.
• Lead critical access decisions end-to-end—owning pricing strategy, payer positioning, and execution with a high degree of autonomy.
• Challenge the status quo by introducing differentiated, insight-driven approaches rooted in real-world payer dynamics and behavior.

This role is highly cross-functional and enterprise-facing, partnering across Commercial, Medical, Patient Services (HUB), Government Pricing, Legal/Compliance, and Supply Chain to shape and deliver meaningful access strategies. The ideal candidate blends strategic vision with operational experience, bringing deep payer expertise and a passion for rare disease patients.

JOB FUNCTIONS/RESPONSIBILITIES

• Lead the development of market access strategies that drive coverage expansion, policy optimization, and quality of access (QOA) improvements across commercial and government payers for inline and pipeline assets
• Identify key differentiators critical to payers for rare disease products in competitive environments and translate into actionable strategy
• Anticipate and shape payer dynamics in rare disease to craft clear, differentiated value narratives that resonate in competitive rare disease markets (UM criteria, specialty pharmacy distribution, generics/biosimilar pressure) for both in-line and pipeline assets
• Translate clinical and economic evidence into practical, payer-ready tools that influence coverage and reimbursement decisions
• Lead pre-launch payer engagement, value evidence planning, and access readiness to ensure optimal coverage pathways, especially in competitive markets
• Partner cross-functionally with medical and marketing to ensure evidence generation is targeted, efficient, and directly aligned to access impact.
• Engage directly with payer stakeholders to uncover actionable insights and convert them into strategic access decisions
• Align with the US Head of Payer Accounts on strategic account planning and escalation for high-impact access challenges
• Act as the enterprise voice of access, influencing key decisions across brand strategy, pricing, and commercialization planning workstreams
• Collaborate with Government Pricing on policy implications (e.g., Medicaid best price, 340B, IRA/GUARD considerations)
• Ensure compliance with all regulatory and legal requirements

QUALIFICATIONS

Education /Experience:

• Bachelor’s degree required; MBA or advanced degree preferred
• 10+ years of experience in market access, payer marketing, or reimbursement, with rare disease experience strongly preferred
• Proven success in launching and optimizing access for specialty/rare disease therapies, including pricing strategy
• Deep understanding of:
• Commercial and government payer dynamics
• Prior authorization, appeals, and reimbursement pathways
• Successful experience in leading and developing a team within the market access function  
• Demonstrated ability to lead cross-functional teams and influence senior leadership in small biotech/rare disease companies with agile working environments a plus
• Strong analytical, strategic, and communication skills
• Resilient and adaptable and proven experience in navigating complex payer dynamics with confidence

The salary range for this position is $280,000 to $315,000 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.

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POSTION SUMMARY

 The Clinical Trial Manager will support the overall management and coordination of operational activities involved in the planning, conduct and completion of clinical trials including the management of deliverables, adherence to budget, and ongoing risk mitigation. The CTM will support the management of selected CROs and help lead cross-functional study. teams to ensure the trial is completed on time, within budget, and with high quality.

 JOB FUNCTIONS/RESPONSIBILITIES

 General:

• Drive the planning, development and execution of timelines, while identifying and tracking the team's critical path.
• Facilitate the project team kick-off meeting by identifying key stakeholders and resources.
• Execute and control project activities, including scope, schedule, budget and risk associated with each assigned project and report performance to senior management.
• Help support the establishment of communication plans for information distribution to team members.
• Support study meetings.
• Support the Clinical Operation’s lead in the reviews at significant milestones or gates to evaluate successes as compared to baseline estimates.
• Identify and track key study metrics to identify/anticipate issues (early) and conduct root-cause investigations for issue resolution and/or escalation (as needed).

Clinical:

• Assist the scientific staff in developing and reviewing protocols, investigator brochures, informed consent forms, clinical study reports and other scientific documents.
• Assist with IND/CTA submission preparation.
• Support the development of plans and execution of those plans related to site monitoring, safety management, data management and biostatistics.
• Help the Clinical Operation Lead in identifying, evaluating, and selecting external vendors (central lab, CROs, consultants/contractors).
• Train and manage CROs and other clinical vendor activities to ensure the quality meets Mirum and regulatory requirements. 
• May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance. Develops/reviews and approves study plans.
• Support the development of contracts for and perform ongoing management of vendors to ensure deliverables and performance adhere to contract.
• Support the identification, selection and proper initiation of sites.
• Help develop patient recruitment strategies to ensure goals are achieved
• Support the development of CRFs, and clinical databases, support development of safety databases, and shell Tables, Figures and Listings.
• Plan and coordinate investigator meetings.
• Plan, coordinate and conduct Data Monitoring Committee (DSMC) meetings.
• Oversee timely database freeze and database lock. Participate in data review meetings.
• Oversee maintenance of the Trial Master File for each study and conduct periodic QC reviews of the TMF to ensure quality.
• Ensure adherence to SOPs, Good Clinical Practice and FDA/ICH regulations.

 QUALIFICATIONS

Education/Experience:

• Bachelor’s degree or equivalent in the life sciences or related field required. Additional coursework or certifications in clinical trial planning and operations desired.
• At least 5 years of relevant experience with project management and clinical development.
• Experience in liver disease is a plus.
• Experience in small, fast-paced biotech is a plus.
• Experience working in a fully outsourced model is a plus.
• Demonstrated experience coordinating interdepartmental activities and efforts to meet protocol and program goals.
• Expert and extensive knowledge of CRO / vendor management and global protocol operations.

Knowledge, Skills and Abilities:

• Must have a demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.
• Proficiency in resource planning and financial management (clinical trial budgeting) required.
• Ability to deal with multiple priorities with aggressive timelines.
• Strong oral and written communication skills.
• Strong social skills to build relationships with Investigators and site staff
• Ability to work with minimal supervision, take initiative and complete tasks to deadlines, and resolve/elevate problems in a timely manner.
• Ability to find creative solutions to issues impacting timelines and budgets.

Work Environment:

• This is a high growth, fast paced organization. The ability to be productive and successful in a fast paced work environment is critical.
• Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 10% of work time.

The salary range for this position is $160,000 to $180,000 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.

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POSITION SUMMARY

The Executive Director, Clinical Development will join the Clinical Development group and will be responsible for all clinical trial related activities in all stages of clinical development in a cross-functional team of internal and external experts, investigators and government agencies. Activities include but are not limited to protocol development, support study startup, oversight of trial execution, recruitment, ongoing clinical development management and closeout as appropriate. Compliance with internal processes, GCP/ICH and regulatory requirements, study and data monitoring, data analysis, are required. Participation in health authority meetings and regulatory filing activities are also part of this role. The Director, Clinical Development, operates in collaboration with other functions including internal Safety and Clinical Operations teams.

JOB FUNCTIONS/RESPONSIBILITIES

• Leadership and management of all aspects of complex, global development clinical study program(s), from phase 1 through registration globally.
• Primary point of contact for medical inquiries from sites, CRO and site monitors; answer or triage questions as appropriate integration of clinical/regulatory strategy into global product development strategy.
• Primary liaison for internal Clinical Operations for site selection, site start-up activities, study management and closeout activities, etc.
• Support the creation of and/or review of clinical slides for internal and external meetings (i.e. Investigator Meetings, SIVs, Advisory Boards, etc.)
• Assist in authoring key clinical study documents, including Protocols, Clinical Study Reports, Investigator Brochures, Regulatory Authority briefing books, Development Safety Update Reports etc.
• Responsible for medical monitoring of efficacy and safety clinical trial data
• Strategic input on the overall development plan, internal and external evaluation of new indications and studies
• Oversight of medical aspects of compliance of and inspection readiness in completed, ongoing and starting clinical trials
• Collaboration in the analysis and writing of scientific publications/presentations
• Works closely with other functions, in particular with Safety function and Clinical Operations
• Co-leads Study Management Team with Clinical Operations lead.

QUALIFICATIONS

Education/Experience:

• MD, with a minimum of ≥5years. 
• Experience in rare disease.
• Knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe.

KNOWLEDGE, SKILLS

• Demonstrated accountability for delivery on complex development plans.
• Leadership in clinical development programs and multidisciplinary trial teams.
• Experience with basic statistical principles and techniques of data analysis, interpretation and clinical relevance.
• Ability to understand and communicate risks, as well as develop and execute contingency plans.
• Experience presenting data to regulatory agencies and advisory committees.
• Ability to think creatively and develop and execute in a fast-paced environment.
• Detail oriented with exceptional organizational skills.
• Effective communicator with strong verbal and written skills.
•  Ability to identify issues, analyze situations and provide effective solutions.
• Solid understanding of the clinical development process.
• Knowledge of applicable regulatory guidance.

Work Environment:

• This is a high growth, fast paced organization. The ability to be productive and successful in a work environment is critical.
• Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 30% of work time.

The salary range for this position is $375,000 to $420,000 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.

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POSITION SUMMARY

Director, Medical Writing works closely with stakeholders in Clinical Development, Clinical Operations, Biostatistics, and other functional areas and manages medical writing service providers to develop Regulatory documents, including but not limited to clinical study protocols and clinical protocol amendments, clinical study reports, patient narratives, clinical development plans, IND submissions, integrated summary reports, NDA/MAA and eCTD submissions, and Investigator Brochures, etc.

JOB FUNCTIONS/RESPONSIBILITIES

• Participate in and oversee vendors for the writing, editing, and confirmation of the scientific and medical accuracy of clinical and regulatory documents.
• Work collaboratively to incorporate/adjudicate comments from internal and external stakeholders through document development to produce final high-quality deliverables.
• Interact with internal stakeholders and with external service providers to ensure the timely development, review, and publication of documents.
• Critically analyze complex data and information and collaborate with clinical, medical, and biostatistics/data science teams on data analysis, description, and presentation.
• Coordinate the development of the documents named above and others as assigned by the Head of Medical Writing.
• Ensure quality control of documents as well as formatting finalization.
• Provide support in development of submission-level documents.
• Ensure adherence to timelines.
• Assist the Head of Medical Writing in coordinating workload and maintaining a high standard. Effectively manage multiple assignments in parallel.
• Prepare documents in accordance with Mirum SOP and specifications as applicable, and relevant ICH and regulatory/industry guidelines.
• Review of Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed.
• Inform management of medical writing problems promptly and propose solutions.
• Provide advice on medical writing issues to project team members (internal and external) and help to resolve problems.
• Represent department in audits and interdepartmental working groups.
• Develop and maintain in-depth scientific, medical, and technical knowledge relevant to Mirum’s clinical studies and pipeline.
• Develop strong relationships with external advisors.

QUALIFICATIONS

Education /Experience:

• An advanced degree with minimum of 8-10 years of experience in medical writing in the pharmaceutical, biotech, medical communication agency industry.
• Excellent writing ability with strong editorial and formatting skills.
• Fluency in written and spoken English.
• An independently motivated working style with good problem-solving skills that allow analysis, synthesis, and compilation of data from a broad range of disciplines.
• Experience managing vendors.
• Rare disease or liver disease background highly desirable.

Knowledge, Skills and Abilities:

• Have a demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and clinical data in English.
• An ability to work in a fast-paced, cohesive, collaborative team-oriented work environment.
• Self-directed and solution oriented.
• Extensive knowledge of FDA and ICH regulations and guidelines, as well as familiarity of AMA Style Guide and Chicago Manual of Style.
• Strong proficiency in Word, Excel, PowerPoint, and other applications.
• Ability to demonstrate a familiarity with principles of clinical research and interpret and present clinical data and other complex information.
• A demonstrated ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to timelines.

The salary range for this position is $230,000 to $245,000 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.

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POSTION SUMMARY

Reporting to the Executive Director, Clinical Supply Chain, the Senior Specialist is responsible for supporting the senior team members in managing the global supply and distribution of investigational drug product for Mirum’s ongoing clinical trials inclusive of the oversight management of multiple Contract Manufacturing Organizations (CMOs) and distribution providers. The ideal candidate is a detailed oriented, self-starter, proactive, with the ability to work independently under minimal supervision.

JOB FUNCTIONS/RESPONSIBILITIES

• Supports the development and execution of Clinical Supply strategies for all Mirum investigational drug products in collaboration with senior team members.
• Assists in creating and maintaining the Clinical Supply forecasting models to ensure investigational material production aligns with corporate and financial goals, study enrollment, and business continuity.
• Supports Clinical Supply program activities for investigational drug product inventory management and distribution in partnership with CMOs; evaluates drug utilization versus forecast considering country requirements and logistical timelines.
• Provides support for the oversight of Clinical Supply CMOs, including assisting in selection (RFI), contract negotiations, financial review, daily operations, and routine assessment of CMO performance via formal Business Reviews.
• Assists with the management of global resupply strategies in IRT systems.
• Interacts with the Clinical Operations, CMC, Quality, and other functions to ensure optimal execution of the Clinical Supply strategy for investigational drug products.
• Supports project-related interactions with IRT vendors and Contract Research Organizations.
• Maintains study and depot-level accountability and reconciliation documentation to support regulatory compliance and study closeout.
• Archives documentation on Trial Master Files as required.
• Archives Proof of Delivery (POD) documentation.
• Responsible for the creation, periodic review, and maintenance of all Clinical Supply SOPs.
• Accountable for initiating, overseeing, and resolving departmental deviations.
• Tracks and resolves temperature excursions.
• Supports the preparation and review of Mirum documentation including regulatory applications, clinical trial applications, routine amendments, protocols, briefing documents, Quality Technical Agreements, responses to health authority inquiries, and other documents as required.

QUALIFICATIONS

Education/Experience:

• Degree in biological or life sciences, pharmacy or medicine (or international equivalent). A minimum of 5 years in the pharmaceutical industry or relevant work experience and a minimum of 3 years in Clinical Supply Chain.
• Familiar in the daily management and operations of a Clinical Supply Chain inclusive of bulk management, distribution, and maintaining study blinds across multiple investigational products.
• Experienced with Clinical Supply Chain systems for inventory management and resupply (Interactive Response Technology – IRT).
• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
• Excellent communication skills both in writing and verbally.
• Assisting as the Clinical Supply Chain support during Regulatory Inspections and Audits.

Knowledge, Skills and Abilities:

• Experienced with Clinical Supply Chain systems for inventory management and resupply (Interactive Response Technology – IRT).
• Knowledge of import / export requirements.
• Proactive in supporting cross-functional collaboration and team performance.
• Good knowledge of industry technology.
• Applies and drives Forecasting and Planning activity as it relates to protocol.
• Ability to build/drive internal team consensus.
• Translates broad strategies into specific objectives and action plans.
• Familiar with team and individual leadership.
• Knowledge and experience relating to clinical trials would be desirable.

The salary range for this position is $115,000 to $125,000 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.

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POSITION SUMMARY

Leads roll out and oversight of Veeva QMS modules, ensuring compliance with applicable regulatory requirements. Manages the development, implementation, and continuous improvement of policies and procedures to maintain quality standards aligned with global regulatory and company guidelines. Partners cross-functionally to ensure effective execution of quality processes. Applies strong knowledge of global regulations to support compliant and efficient operations. Contributes to the strategic direction and ongoing performance of the Quality Management System (QMS), driving consistency, inspection readiness, and continuous improvement initiatives.

JOB FUNCTIONS/RESPONSIBILITIES

• Lead the end-to-end implementation and rollout of new modules within Veeva, ensuring alignment with business needs and regulatory requirements.
• Serve as the Quality Systems lead and subject matter expert (SME) processes, driving standardization and harmonization across the organization.
• Partner with cross-functional stakeholders (Quality Assurance, Manufacturing, Supply Chain, and IT) to define system requirements, workflows, and business processes.
• Oversee system configuration, user acceptance testing (UAT), and validation activities (e.g., CSV/CSA) to ensure the system is fit for intended use and compliant with global GMP regulations.
• Assist with developing and executing implementation plans, including timelines, resource planning, risk mitigation strategies, and communication plans.
• Author and/or review governing documents (SOPs, work instructions, and training materials) to support the new modules and ensure alignment with QMS requirements.
• Lead training strategy and rollout, including role-based curricula, to ensure successful user adoption and adherence to new processes.
• Monitor system performance and user feedback post-implementation; identify and implement continuous improvements and enhancements.
• Collaborate with internal stakeholders to ensure alignment and effective utilization of newly implemented and current modules.
• Act as the primary point of contact for system-related issues, deviations, and change controls.
• Support internal and external audits and health authority inspections by providing system documentation, demonstrating functionality, and addressing inquiries.

QUALIFICATIONS

Education /Experience:

• Bachelor’s degree in scientific discipline

Knowledge, Skills and Abilities:

• 12+ years’ experience and strong background in Quality and Quality Systems in the drug development industry with knowledge of cGMP/ICH/FDA/EMA regulations
• Prior experience implementing or supporting electronic QMS platforms, ideally Veeva Vault QMS
• Strong project management and change management skills is a plus
• Ability to drive process standardization and continuous improvement
• Demonstrate a quality mindset and ability to influence across the organization
• Successful experience writing and reviewing SOPs and other Quality documents.
• Expert knowledge of phase appropriate cGxPs and experience leading Quality System implementation and continuous improvement efforts.
• Demonstrated ability to successfully interact with regulatory health authorities at inspections and thorough understanding of audit and vendor management programs.
• Excellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneously
• Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.

The salary range for this position is $197,129 to $221,404 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.

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POSITION SUMMARY

The Director of Clinical Pharmacology will be responsible for all aspects of clinical pharmacology in the development and approval of Mirum rare disease assets.  As a key member of the small Clinical Pharmacology & Nonclinical Sciences group, the individual will represent these multiple functions on multidisciplinary drug development teams to define the strategy and oversee the execution of required studies/analyses through CROs to achieve team goals.

JOB FUNCTIONS/RESPONSIBILITIES

• Serves as the clinical pharmacology lead on project and study teams, providing subject matter expertise on clinical development programs
• Leads the design and is responsible for the execution of the clinical pharmacology strategy (from study design, planning, and oversight to data analysis, interpretation, and reporting) in support of key decisions/milestones (e.g., dose selection)
• Manages collaborations with CROs and consultants, providing technical oversight as needed and ensuring timely and quality deliverables to fulfill project goals
• Leads the authoring of clinical pharmacology sections of regulatory documents (clinical study protocol, CSR, Investigator’s Brochure, IND, NDA, MAA, briefing materials, response to queries)
• Plays a key role in due diligence efforts for potential drug in-licensing or partner opportunities, including review of existing data and development of clinical pharmacology strategy

QUALIFICATIONS

• Prior experience with assets in liver, neurology, or rare disease indications is a plus
• Experience with various therapeutic modalities (small molecule, antibody, ADC)

Education/Experience:

• BS in Biological Sciences with 12-15+ years or an advanced degree (PhD, PharmD) with 10+ years of experience in clinical pharmacology

Knowledge, Skills and Abilities:

• Proficiency in the design, execution, and interpretation of clinical pharmacology studies, including PK and PD assessments
• Thorough understanding of clinical pharmacology requirements, including regulatory guidance, to support drug development
• Proven track record of success as both an individual contributor and a collaborative team member
• Experience authoring and supporting regulatory filings (IND, NDA, MAA)
• Experience coordinating studies through CROs
• Solid knowledge of GCP compliance in supporting clinical studies
• Proficient in regulatory interactions both written and verbal
• Knowledge of PopPK, PBPK, exposure-response, or PK/PD modeling
• Solid project management skills: ability to create and manage project plans, budgets, and schedules
• Strong communication skills (written and verbal) and interpersonal skills with an ability to communicate to people at all levels of the organization
• Recognized for being self-directed, well-organized, flexible, and detail-oriented; able to complete multiple activities while maintaining quality

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POSITION SUMMARY

The Associate Director of GCP/GVP/GLP-QA is responsible for supporting Mirum’s clinical study programs as the GCP-QA representative on the study management team; managing activities involving GCP quality assurance and compliance with applicable regulatory requirements; development and implementation of policies and procedures to ensure quality standards in compliance with relevant regulatory and quality guidelines. Additionally, this position will support GVP and GLP QA operational activities to ensure data integrity and meeting regulatory expectations and industry standards. 

This position requires experience with global contract research organizations (CROs) and GCP Vendors as well as knowledge of global GCP regulations.

JOB FUNCTIONS/RESPONSIBILITIES

• Achieve established timelines for deliverables.
• QA Representative for assigned Mirum’s Program’s Clinical Study Management Teams.
• Manage/Support BIMO inspection readiness activities
• Support GCP/GCLP/GVP internal audits.
• Provide quality oversite for the GCP/GVP/GLP vendor activities, including internal/external deviations, CAPAs, change controls, and KPIs/KQIs.
• Support GCP, GCLP and GVP Vendor Management/Audit Program. Ad hoc audits may be requested.
• Assist with planning and supporting Clinical Site Management/Audit Program. Ad hoc site audits may be requested.
• Assist with and support regulatory agency inspections for the GCP and PV impacted functions.
• Provide GCP/GCLP/GVP Training as necessary
• Support Quality Management Team (QMT) by providing monthly/quarterly updates based on role and responsibilities
• Support process improvement of QA department, KPI/QPI tracking and oversight.
• Manage GCP/GVP/GLP consultant(s) as needed

QUALIFICATIONS

Education /Experience:

• Bachelor’s Degree in a scientific discipline.
• 10-12 years of experience in the pharmaceutical industry, including 5-10 years in GCP Quality and 5+ years supervising GCP Quality internal staff and/or external consultants.
• Knowledge and demonstrated experience in the applicable GCP regulations, FDA Regulations and Good Clinical Practices, EMA EudraLex Regulations, and ICH Guidelines.
• Strong verbal and written communication.
• Knowledge of basic GVP, GCLP and GLP regulations.

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.

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POSITION SUMMARY

We are seeking an experienced Director, GMP Quality Assurance (QA) Operations to provide strategic and operational leadership in managing quality for outsourced manufacturing and testing operations, ensuring product quality, regulatory compliance, and reliable supply of clinical material. This role will be a key cross-functional partner, and will work closely with CMC, Supply Chain, Quality Control, and Regulatory teams to drive quality strategy, continuous improvement, and operational excellence. It would be specializing in QA support of late phase development to commercial biologics manufacturing. 

Responsibilities:

• Manage and provide oversight of routine operations conducted by external partners, including CDMOs and testing labs
• Provide timely feedback for GMP quality events and escalate to management for aligned decisions, as appropriate.
• Ensure timely batch record review, product disposition, and compliance with regulatory requirements
• Develop and monitor partner performance metrics, risk assessments, and escalation pathways
• Collaborate with internal CMC, Regulatory, Quality Control, and Supply Chain teams to support technical transfers, process development, and regulatory submissions
• Serve as GMP SME for cross-functional initiatives to strengthen quality systems, enhance compliance, and drive operational efficiency
• Serve as a primary QA representative during regulatory inspections (FDA, EMA, and other global authorities), including hosting inspections, responding to questions, and managing commitments.
• Own inspection follow-up activities, including CAPA development, execution, and effectiveness verification.
• Champion a culture of quality and inspection readiness across internal and external operations

Qualifications:

• Bachelor’s or advanced degree in Biology, Chemistry, Chemical Engineering, or related scientific field
• 10+ years of progressive cGMP Quality Assurance experience supporting biologics manufacturing and analytical testing in a regulated environment, Person in Plant, and direct Inspection experience with domestic and international regulatory agencies
• Direct experience managing external partners/CDMOs and ensuring compliance from clinical supply through validation to commercial supply
• Strong knowledge of FDA, EMA, ROW CGMP regulations, and ICH guidance
• This is a hybrid on-site / remote work schedule, with 3 days on-site per week

The salary range for this position is $220,000 to $235,000 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.

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POSITION SUMMARY 

This role will be responsible for owning and supporting Mirum’s Salesforce Life Sciences Cloud (SFLC) platform that powers the Patient CRM and HCP Portal. This Senior Manager role serves as the IT Platform lead with primary accountability for platform stabilization, operational excellence, and scalability following initial implementation and go-live of the Patient Services Hub. Over time, this role will expand to support additional Commercial systems related to customer engagement platforms. The ideal candidate is a highly skilled CRM platform leader with deep experience in regulated life sciences environments, complex CRM implementations, and cross-system integrations.

JOB FUNCTIONS/RESPONSIBILITIES 

• Salesforce Platform Ownership & Leadership
• Serve as the IT platform owner for Salesforce Life Sciences Cloud platform supporting Patient CRM and HCP Portal capabilities.
• Assume platform ownership during the final phase of implementation to ramp up, assess solution design, and prepare for steady-state operations.
• Provide strategic leadership for platform stability, scalability, and long-term roadmap post–go-live.
• Own Salesforce account, user, role, profile, and territory management, ensuring appropriate access controls and alignment with business operating models.
• Oversee reporting and dashboard creation, supporting operational visibility for Patient Services and HCP engagement teams.
• Utilize Salesforce Workbench and other approved tools to perform secure data exports, analysis, and issue investigation in support of operational and compliance needs.

• Post–Go-Live Stabilization & Operations

• • Lead post-launch stabilization, including production support, incident management, and root cause analysis.
  • Own backlog prioritization, defect remediation, and technical debt reduction following initial implementation.
  • Establish and mature operational processes, including monitoring, support models, and release management.
• Stakeholder Management & Prioritization
  • Partner with Patient Services and business stakeholders to support and enhance the platform
  • Ensure platform configurations, data models, security, and workflows align with evolving patient and HCP needs.
  • Enable controlled enhancements while minimizing risk to live operations.

• Governance, Compliance & Risk Management

• • Own Salesforce platform governance, ensuring alignment with Mirum’s security, privacy, and compliance requirements.
  • Implement and enforce change management, access controls, and audit-ready documentation.
  • Act as the primary IT escalation point for platform-related risks impacting patient services or HCP engagement.

• Collaboration & Continuous Improvement

• • Partner with implementation vendors, integration teams, and enterprise architecture to ensure knowledge transfer and solution continuity.
  • Document platform architecture, configurations, and operational procedures to ensure long-term maintainability.
  • Stay current on Salesforce Life Sciences Cloud capabilities and recommend improvements that enhance operational efficiency and scalability.

QUALIFICATIONS

• Bachelor’s degree in Computer Science, Information Systems, Engineering, or a related field.
• 6+ years of experience supporting Salesforce platforms in regulated industries, with leadership experience preferred.
• Proven experience owning platforms post-implementation, including stabilization and steady-state operations.
• Strong experience with Salesforce Life Sciences Cloud or complex Salesforce CRM implementations.
• Experience supporting Commercial systems such as Veeva CRM, Master Data Management, Events Management, or similar HCP engagement platforms preferred.
• Demonstrated ability to lead cross-functional teams and manage vendor-delivered solutions.

 Knowledge, Skills and Abilities:

• Strong knowledge of core Commercial and Patient Services processes, including territory alignment, HCP/HCO customer master data management, patient enrollment and case management workflows, and compliant HCP engagement.
• Deep expertise in Salesforce architecture, security model, data design, automation, integrations, reporting, and environment management (preferably Salesforce Life Sciences Cloud).
• Proven ability to lead post–go-live stabilization, production support, backlog prioritization, and steady-state platform operations.
• Experience integrating CRM with Commercial ecosystem systems such as MDM, data warehouses, marketing automation, and HCP engagement platforms
• Strong leadership, analytical, and stakeholder management skills with the ability to balance strategic roadmap ownership and hands-on operational accountability.

• Excellent problem-solving and decision-making skills in production environments.
• Strong communication and stakeholder management skills in fast-paced, regulated environments.

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.

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POSITION SUMMARY

The Senior Director, Global Regulatory Affairs will play a significant role in providing regulatory strategic leadership on multiple clinical development programs associated with rare diseases in assigned Therapeutic Area (TA). This role will represent the regulatory function and provide guidance to Program Teams across the organization which include Clinical Development, Clinical Operations, Biometrics, Nonclinical Science, Drug Safety and Pharmacovigilance, and Quality Assurance for assigned projects. This role will be the Global Regulatory TA Lead, responsible for ensuring global regulatory compliance and overseeing timely delivery of submissions and approvals of regulatory procedures including but not limited to IND, NDA, MAA, and life cycle management activities for multiple projects. 

JOB FUNCTIONS/RESPONSIBILITIES

• Develops and oversees the global regulatory strategy for projects in assigned TA, in conjunction with and under the leadership of the SVP, Global Regulatory Affairs.
• Leads the Global Regulatory Project Team meetings in collaboration with Regulatory Project Management when being the Global Regulatory Lead on a project.
• Oversees the preparation of regulatory documentation (meeting request/briefing books) in support of interactions with a Health Authority and provide guidance to their team.
• Oversees/leads the preparation and the critical review of submission documents to ensure compliance with regulatory requirements.
• Contributes to and reviews responses to global Health Authority questions to ensure appropriate, consistent, and complete responses, ensuring their alignment with global development strategy.
• Provide global regulatory advice through the product life cycle by representing the regulatory function in the Program Team when being the Global Regulatory Lead on a project.
• In partnership with Regulatory Project Management, Regulatory Labelling and Regulatory CMC, oversees the development of content and format for regulatory submissions and related variations/amendments internationally in assigned TA.
• Actively participates in Health Authority meetings.
• Clearly articulate regulatory challenges/risks, identify potential solutions, and make a recommendation(s) on a path forward to Program Teams and Senior Management.
• Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating regulatory changes to Program Teams.
• Effectively manages direct report(s) and provide mentorship to junior professionals.

QUALIFICATIONS

• Bachelor’s or Master’s degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent); an advanced degree is desirable.
• A minimum of 15 years in the pharmaceutical industry with a minimum of 12 years in Global Regulatory Affairs, experience with major Health Authorities (US FDA, Health Canada, and EMA) is mandatory.
• Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
• Experience with major regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), Paediatric Investigation Plans (PIP) and Orphan Drug Designation (ODD) activities) is highly preferred.
• Experience in all phases of development and post marketing activities is highly preferred.
• Demonstrated ability to analyze and interpret efficacy and safety data.
• Strong understanding of regulatory operational activities.
• Outstanding people management skills are required.
• Outstanding interpersonal and communication skills.
• Experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on the regulatory strategy for a given product is required.
• Demonstrated proficiency in organizational awareness, including experience working cross-functionally representing the Regulatory Affairs function and on global teams.
• Excellent planning and organizational skills and ability to work simultaneously on multiple projects with tight timelines.
• Supports the SVP, Global Regulatory Affairs as required.

Work Environment:

• This is a high-growth, fast-paced organization. The ability to be productive and a team player is critical.
• Ability to work under minimal supervision.
• Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 10-15% of work time.
• On site presence at the headquarter is required (minimum 2 days a week).

The salary range for this position is $289,000 to $320,000 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.

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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.

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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.

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POSTION SUMMARY

 The Senior Manager, Clinical Data Management will collaborate primarily with internal team members and external vendors to manage all data collection and data reporting aspects. In addition, the Senior Manager will lead the development of systems and procedures to assure consistency across the Clinical Data Management department.   Overall responsibilities will include supporting clinical data management activities from study start-up through study closure in support of trial objectives and corporate goals in accordance with Standard Operating Procedures (SOPs) and regulatory directives. Participate in staff recruitment, onboarding, training and mentoring. 

PRIMARY RESPONSIBILITIES

• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies, build effective relationships with CRO/vendor counterparts
• Able to review and provide feedback to the multi-disciplinary team on other study documents e.g. clinical study protocols, protocol deviation plans, medical monitoring plan, statistical analysis plan, mock Tables, Figures and Listings (TFL) shells and Clinical Study Reports (CSRs)
• Reviews and approves DM related documentation for quality, completeness, and accuracy; including but not limited to Case Report Forms, Data Validation Specifications, Case Report Form Completion Guidelines, Data Management Plans, Data Transfer Agreements, Medical Coding Guidelines, Validation Plan, User Acceptance Testing (UAT) documentation, Data Review Plan, etc.
• Track and manage progress towards data deliverables through effective metrics tracking, analysis, and reporting
• Develop and execute procedures for data quality review and data acceptance prior to data analyses and/or database lock
• Knowledge of standard coding dictionaries MedDRA, WHOdrug, etc., and related best practices
• Attends and represents CDM effectively on all assigned studies and programs at relevant meetings.
• Understand critical tasks and milestones; ensure data management deliverables are met per study timelines
• Manage the clinical study budget, ensuring the project remains within scope through reviewing and approving invoices, identifying out-of-scope activities and its appropriate handling
• Work collaboratively with biostatistics, programming and other functions to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting
• Monitor in-house resources of assigned projects and identify potential deficiencies; work with supervisor to develop and implement a plan to overcome any obstacles
• Contribute to developing and implementing departmental policies, standards and process improvement initiatives as needed
• Support implementation of data standards
• Align with and support management and corporate goals or objectives
• Contribute to activities supporting audits & inspection readiness and regulatory inspections
• Assist in selecting vendors/CROs e.g. reviewing RFIs/RFPs and participating in bid defenses
• Identify, manage, mentor and develop Clinical Data Management team members
• Good working knowledge of medical/scientific terminology and knowledge of ICH guidelines and regulations relating to data management activities

QUALIFICATIONS

Education/Experience

• Bachelor’s Degree preferably in a scientific or health-related discipline; Master’s degree is a plus
• 8+ years of clinical data management experience in a pharmaceutical/biotech setting

Knowledge, Skills and Abilities

• Proven ability to prioritize and manage multiple tasks with conflicting deadlines in support of corporate goals and objectives
• Experience in managing outsourced clinical data management activities and/or other vendors
• Thorough understanding of the drug development process, clinical trial methodology, regulatory requirements, ICH, GCP and GCDMP
• Current and extensive knowledge of industry CDM best practices and processes
• Strong experience with various clinical database management systems including EDC, eCOA, and ePRO
• Strong and effective oral and written communication, project management, and interpersonal skills
• Proven success working in a virtual, global and multi-cultural environment
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
• Proven success in identifying creative solutions to complex study-related or technical issues
• Knowledge of SAS, EDC programming, systems integration experience
• Solid understanding of CDASH and CDISC standards
• Ability to mentor junior staff

The salary range for this position is $185,000 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.

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POSITION SUMMARY 

Lead for NonClinical and Clinical Pharmacology Functions at Mirum.

JOB FUNCTIONS/RESPONSIBILITIES

• Lead the design and execution of a nonclinical and clinical pharmacology development plan for all Mirum assets
• Develop resource plan via employees and vendors to enable nonclinical and clinical pharmacology development of Mirum assets
• Manage nonclinical team members and coordinate across functions to achieve nonclinical and clinical pharmacology goals
• Continually review and monitor guidance, regulations, and publications in nonclinical and clinical pharmacology development and relevant therapeutic areas
• Assess nonclinical safety findings for potential expedited safety reporting
• Provide input on clinical safety programs (informed consent, exclusion criteria, pregnancy, etc.) and clinical pharmacology programs (ADME, DDIs, PK/PD, BE, etc)
• Identify and work with expert consultants as needed to fill project needs
• Ensure the completion of the relevant sections of IND, NDA, MAA, other regulatory documents, and ensure robust responses for information requests
• Represent nonclinical and clinical pharmacology with regulatory agencies (responses to queries, preparation of pre-meeting documents, attend teleconferences and meetings with Health Authorities, as needed)
• Lead due diligence efforts for potential drug in-licensing or partner opportunities, including assessment and review of existing data and development of nonclinical strategy
• Provide expertise and execute non-clinical efficacy research for translation into clinical programs, including resourcing appropriate animal models and interpretation of results, in partnership with senior management team

QUALIFICATIONS 

Education/Experience:

• Advanced science degree (e.g. PhD, PharmD)
• Board certification in toxicology (DABT) preferred
• 10+ years leadership experience and 15+ years drug development experience

 Knowledge, Skills and Abilities: 

• Ability to understand and effectively communicate scientific information
• Thorough understanding of the nonclinical and clinical pharmacology requirements, including regulatory guidance, to support drug development in US and EU
• Deep knowledge of toxicology study design and interpretation, pharmacodynamics and pharmacokinetics modeling
• Extensive experience coordinating studies through CROs
• Extensive experience authoring and supporting regulatory filings (INDs, NDAs, MAA, DSURs, IBs, etc)

The salary range for this position is $300,000 to $330,000 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.

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POSITION SUMMARY

Mirum is seeking a Contracts Manager who will partner with internal stakeholders to draft, redline, review, negotiate and execute clear agreements with external business partners and providers. The types of agreements include a variety of commercial and clinical trial agreements, including software licensing, Master Services Agreements, Statements of Work, Amendments, Manufacturing, Supply, Quality, HCP and General Consulting Agreements and well as the full suite of Clinical trial agreements (CTAs, LOIs and PI acknowledgements). This role will prepare, negotiate, and manage contracts and/or contract activities across multiple functions and domestic and international environments using an internal contract management system. The successful candidate will have significant experience in contracts drafting and negotiations in the pharma industry, as well as experience working in fast-paced, start-up, high growth environments.

JOB FUNCTIONS/RESPONSIBILITIES

• Structure, draft, redline, review and negotiate contracts: Ensure accuracy and appropriateness of contract language relative to the business need, compliance with all laws and regulations and company policies and procedures.
• Collaborate with cross-functional teams to understand business needs, identify issues, and obtain input on timelines and deliverables.
• Utilize and champion the CLM platform to track, monitor, and report on contract status, renewals, and obligations.
• Structure, draft, and negotiate contract terms based on strategy discussions, key stakeholder input, approved contract standard terms and conditions, and organizational needs and expectations.
• Ensure that the contract is complete, accurate and all risks have been identified to the business owner and the proper reviews/approvals completed prior to execution.
• Work with business owners on any amendments, contract terminations, and/or contract renewals.
• Ensure contracts are recorded and maintained in the repository.
• Coordinate with other departments to ensure compliance with internal policies and legal requirements.
• Manage electronic execution of agreements through DocuSign and ensure proper integration into the contract repository.
• Assist with other projects as needed/requested.

QUALIFICATIONS

Education/Experience:

• Minimum 5+ years’ experience in contracts management required.
• Experienced professional in contract drafting, review, redline, negotiation and finalization with the ability to understand and draft complex legal and business terms.
• Experience with a variety of clinical and commercial agreements preferred.
• Solid understanding of legal terminology and contract management software.
• Experience in Life Science or Biotechnology industries required.
• Familiarity with international agreements preferred.
• Knowledge of international organizational structures preferred.
• Detail oriented, strong organizational skills and ability to work independently in a start-up environment.
• Strong communication skills.
• Ability to demonstrate sound judgement even in ambiguous situations.
• Common sense, great judgement, and a good sense of humor.
• Ability to operate with a sense of urgency.
• Willingness and ability to work with high volume of contracts.
• Business acumen and ability to understand business needs.

Knowledge, Skills and Abilities:

• Problem Solving/Legal and Business Analysis
• Customer-Service/Client Focus
• Excellent organizational skills
• Time management skills
• Decision Making
• Desire to learn
• Proficient in SharePoint, Outlook, Word, PowerPoint, Excel, Box, Contracts Lifecycle Management software.

The salary range for this position is $145,000 to $160,000 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.

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POSITION SUMMARY

The Associate Director of Clinical Pharmacology will be responsible for all aspects of clinical pharmacology in the development and approval of Mirum rare disease assets.  As a key member of the small Clinical Pharmacology & Nonclinical Sciences group, the individual will represent these multiple functions on multidisciplinary drug development teams to define the strategy and oversee the execution of required studies/analyses through CROs to achieve team goals.

JOB FUNCTIONS/RESPONSIBILITIES

• Serves as the clinical pharmacology lead on project and study teams, providing subject matter expertise on clinical development programs
• Leads the design and is responsible for the execution of the clinical pharmacology strategy (from study design, planning, and oversight to data analysis, interpretation, and reporting) in support of key decisions/milestones (e.g., dose selection)
• Manages collaborations with CROs and consultants, providing technical oversight as needed and ensuring timely and quality deliverables to fulfill project goals
• Leads the authoring of clinical pharmacology sections of regulatory documents (clinical study protocol, CSR, Investigator’s Brochure, IND, NDA, MAA, briefing materials, response to queries)
• Plays a key role in due diligence efforts for potential drug in-licensing or partner opportunities, including review of existing data and development of clinical pharmacology strategy

QUALIFICATIONS

• Prior experience with assets in liver, neurology, or rare disease indications is a plus
• Experience in PopPK, PBPK, exposure-response, or PK/PD modeling is a plus

Education/Experience:

• BS in Biological Sciences with 7+ years or an advanced degree (PhD, PharmD) with 3+ years of experience in clinical pharmacology

Knowledge, Skills and Abilities:

• Proficiency in the design, execution, and interpretation of clinical pharmacology studies, including PK and PD assessments
• Thorough understanding of clinical pharmacology requirements, including regulatory guidance, to support drug development
• Proven track record of success as both an individual contributor and a collaborative team member
• Experience authoring and supporting regulatory filings (IND, NDA, MAA)
• Experience coordinating studies through CROs
• Solid knowledge of GCP compliance in supporting clinical studies
• Solid project management skills: ability to create and manage project plans, budgets, and schedules
• Strong communication skills (written and verbal) and interpersonal skills with an ability to communicate to people at all levels of the organization
• Recognized for being self-directed, well-organized, flexible, and detail-oriented; able to complete multiple activities while maintaining quality

The salary range for this position is $195,000 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.

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POSITION SUMMARY

We are seeking an experienced Senior Director, Intellectual Property to lead our intellectual property (IP) strategy in support of our mission to develop and commercialize transformative therapies for patients with rare diseases. This role reports to the Chief Legal Officer, requires a balance of strategic acumen and hands-on execution and will be responsible for shaping and executing a comprehensive global IP program across our clinical and commercial programs. As a senior legal leader in a dynamic, high-growth biopharmaceutical organization (~350 employees worldwide), you will partner closely with internal teams and outside counsel to maximize the value of our programs while mitigating risk.

PRIMARY RESPONSIBILITIES

IP Strategy & Portfolio Management

• In partnership with the Chief Legal Officer and outside intellectual property counsel, develop and oversee a global IP strategy for the company’s patents, trademarks and trade secrets.
• Lead and oversee the drafting, filing, prosecution, and maintenance of a worldwide patent portfolio.
• Provide guidance on patent term extensions and regulatory exclusivities.
• Deliver freedom-to-operate (FTO), patent validity, and infringement analyses to inform decision-making across development and commercial programs.
• Manage the company’s global trademark portfolio.

Transactional Support

• Provide IP guidance in business development, licensing, collaboration, and M&A transactions; lead or support IP due diligence efforts.
• In collaboration with other Legal team members, draft and negotiate IP provisions in material agreements (e.g., research collaboration, license, clinical, supply, manufacturing and distribution agreements).

Litigation & Disputes

• With the Chief Legal Officer and outside counsel, manage potential Hatch-Waxman patent litigation.
• Direct and manage patent dispute processes such as U.S. inter partes review (IPR), post-grant proceedings, European oppositions, and other adversarial actions in key jurisdictions.
• Support pre-litigation risk assessments.

Legal & Business Support

• Partner with program teams and internal functions to identify and capture inventions at an early stage.
• Evaluate inventions and determine whether patent or trade secret protection would be appropriate.
• Support product launches with lifecycle management strategies.
• With the Chief Legal Officer, manage outside counsel relationships with a focus on cost-effectiveness and quality.
• Deliver timely, practical, and business-focused legal advice across jurisdictions.

QUALIFICATIONS

• J.D. and licensed to practice law in at least one U.S. jurisdiction (active and in good standing).
• USPTO registration and eligibility to practice patent law.
• 12+ years of intellectual property law experience, with significant in-house and/or law firm experience in the biopharmaceutical sector.
• Advanced scientific degree (M.S. or Ph.D.) in chemistry, biochemistry or related discipline.
• Strong global perspective, with experience managing patent portfolios across the U.S., EU, UK and Japan.
• Proven track record advising executives and program teams, balancing legal risk with business goals.
• Excellent written and oral communication skills — able to translate complex IP concepts for diverse stakeholders.

Preferred

• Experience with rare disease regulatory frameworks, including orphan drug exclusivity in the U.S. and EU.
• Demonstrated success in managing patent litigation, disputes, oppositions, or post-grant proceedings.

KNOWLEDGE, SKILLS, AND ABILITIES

• Mission-driven, passionate about bringing therapies to patients with serious, underserved rare diseases.
• Strategic thinker with hands-on execution ability in a small organization.
• Collaborative, approachable and comfortable working cross-functionally in a fast-paced, global culture.
• Entrepreneurial and creative mindset with flexibility to pivot quickly as business needs evolve.
• Strong leadership presence, credibility, and collaborative mindset.

The salary range for this position is $315,000 to $335,000 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.

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POSITION SUMMARY

We are seeking an experienced Senior Director, Development Quality (GMP) who will be responsible for providing strategic and operational quality oversight for product development activities from early development through commercialization. This role ensures compliance with global GMP regulations and supports development, scale-up, and technology transfer of drug substance, drug product, and finished product.

This position requires extensive experience in GMP Quality Assurance, including oversight of CMC development, clinical manufacturing, and global supply, along with strong knowledge of regulatory expectations across all phases of development..

JOB FUNCTIONS/RESPONSIBILITIES

• Serve as a strategic Quality leader to support development and advancement of a compliant, phase-appropriate, and collaborative GMP quality culture across development and technical operations.
• Provide QA oversight of product development lifecycle activities, including drug substance (DS), drug product (DP), and finished product (FP) from early development through commercialization.
• Oversee and support GMP quality systems applicable to development, including deviations, CAPAs, change control, investigations, and product complaints.
• Provide QA support for clinical manufacturing, including batch record review/disposition and release of DS, DP, and FP for clinical use.
• Ensure quality oversight of process development, technology transfer, scale-up, and validation activities.
• Support preparation, review, and approval of CMC sections for regulatory submissions (e.g., IND, NDA, MAA) and responses to regulatory authority questions.
• Interface with regulatory agencies and support GMP inspections, including pre-approval inspections (PAIs) and general GMP inspections.
• Identify compliance risks within development and manufacturing activities and escalate issues to appropriate levels of management.
• Oversee and support GMP vendor management, including qualification, auditing, and ongoing oversight of CMOs, laboratories, and suppliers.
• Establish and maintain Quality/Technical Agreements with CMOs and development partners.
• Support new product introduction, acquisition, and integration activities from a GMP quality perspective.
• Support development and oversight of stability programs for investigational and commercial products.
• Develop, track, and trend quality metrics for reporting to Quality Management Review (QMR) and Annual Product Reviews (APR/APQR).
• Ensure inspection readiness across development and clinical manufacturing operations.
• Collaborate cross-functionally with Technical Operations, CMC, Regulatory Affairs, Supply Chain, and Manufacturing.
• Build, mentor, and lead a high-performing Development Quality team.
• Champion a culture of quality and inspection readiness across internal and external operations

QUALIFICATIONS

Education /Experience:

• Bachelor’s degree in a scientific discipline; advanced degree (MS, PhD) preferred.
• 15+ years of experience in the pharmaceutical/biotech industry, including 12+ years in GMP Quality Assurance.
• Strong expertise in global GMP regulations, including FDA, EMA (EudraLex), ICH guidelines, and Good Manufacturing Practices.
• Demonstrated experience supporting product development from early stage through commercialization, including clinical manufacturing.
• Strong knowledge of CMC development, process validation, technology transfer, and manufacturing operations.
• Experience supporting regulatory submissions (IND, NDA, MAA) and health authority inspections, including PAIs.
• Experience with GMP vendor oversight, including CMOs and contract laboratories.
• Proven leadership experience with the ability to build and develop high-performing teams.
• Strong understanding of pharmaceutical supply chain and lifecycle management.
• Experience with inspection readiness and continuous improvement of quality systems.
• Excellent communication, collaboration, and risk management skills.
• Strong knowledge of FDA, EMA, ROW CGMP regulations, and ICH guidance

The salary range for this position is $275,657 to $310,847 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.

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POSITION SUMMARY

The Director/Senior Director, Clinical Development will be responsible for all clinical trial related activities for Brelovitug, a key asset in Phase 3 on a cross-functional team of internal and external experts, investigators and government agencies. Activities include but are not limited to protocol development, support study startup, oversight of trial execution, recruitment, ongoing clinical development management and closeout as appropriate. Compliance with internal processes, GCP/ICH and regulatory requirements, study and data monitoring, data analysis are required. Participation in health authority meetings and regulatory filing activities are also part of this role. The Director/Senior Director, Clinical Development operates in collaboration with other functions including internal Safety, Regulatory, Biometrics, and Clinical Operations teams.

JOB FUNCTIONS/RESPONSIBILITIES 

• Leadership and management of all aspects of complex, global development clinical studies.
• Primary point of contact for clinical inquiries from sites, CRO and site monitors; answer or triage questions as appropriate integration of clinical/regulatory strategy into global product development strategy.
• Primary liaison for internal Clinical Operations for site selection, site start-up activities, study management and closeout activities, etc.
• Support the creation of and/or review of clinical slides for internal and external meetings (e.g. Investigator Meetings, SIVs, IDMCs, Advisory Boards, etc.)
• Assist in authoring key clinical study documents, including Protocols, Clinical Study Reports, Investigator Brochures, Regulatory Authority briefing books, Development Safety Update Reports etc.
• Strategic input on the overall development plan, internal and external evaluation of new studies
• Oversight of clinical aspects of compliance of and inspection readiness in completed, ongoing and starting clinical trials
• Collaboration in the analysis and writing of scientific publications/presentations
• Works closely with cross-functional team members
• Co-leads Study Management Team with Clinical Operations lead.

QUALIFICATIONS

Education/Experience:

• MD, PharmD, PhD or equivalent is preferred with ≥3 years of drug development in industry, academia, or a related environment, working within cross‑functional project or program teams with proven success.
• Experience in Liver or rare disease a plus.
• Knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe.

 Knowledge, Skills and Abilities:

• Demonstrated accountability for delivery on clinical studies.
• Leadership in clinical development programs and multidisciplinary trial teams.
• Experience with basic statistical principles and techniques of data analysis, interpretation and clinical relevance.
• Ability to understand and communicate risks, as well as develop and execute contingency plans.
• Ability to think creatively and develop and execute in a fast-paced environment.
• Detail oriented with exceptional organizational skills.
• Effective communicator with strong verbal and written skills.
• Ability to identify issues, analyze situations and provide effective solutions.
• Solid understanding of the clinical development process.
• Knowledge of applicable regulatory.

Work Environment:

• This is a high growth, fast paced organization. The ability to be productive and successful in a work environment is critical.
• Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 20% of work time.

The salary range for this position is $220,000 to $240,000 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.

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POSITION SUMMARY

The Associate Director, Program Management plays a central role within Mirum by providing program management expertise and ensuring cross-functional planning and execution. The program manager partners with the Program Lead and functional leads to develop and manage the integrated product plan, develop timelines, and ensure adherence to the budget for one of our pipeline programs. 

JOB FUNCTIONS/RESPONSIBILITIES

• Support the Program Lead with the development, communication, and timely execution of the program strategy
• Organize and drive effective and action-oriented program team meetings by preparing and distributing agendas/minutes, identifying and tracking decisions and action items to resolution, and escalating areas of concern as needed
• Partner with the Program Lead to facilitate effective cross-functional decision making with transparent communication and clear escalation pathways
• Facilitate identification of risks which could impact the program’s strategic goals; propose and implement plans to mitigate risks or develop contingencies
• Develop and maintain integrated program timelines in conjunction with functional leads
• Identify and communicate program priorities, interdependencies, and critical path activities to all stakeholders to allow long term planning, including resource allocation
• Organize the preparation of high-quality documents for review by governance committees in collaboration with the Program Lead and program team
• Prepares and provides project documents and information for monthly reports, executive team updates, and board meetings.
• Partner with Program Lead and finance and accounting to develop annual operating plan components related to assigned program and support budget management by timely identification of out-of-scope activities
• Coordinate and manage special program-related projects, as assigned
• Contribute to the standardization of project management best practices at Mirum

 QUALIFICATIONS

Education /Experience:

• Bachelors Degree or higher in scientific/healthcare/business field
• Experience (7+ years) in clinical research and project management within the pharmaceutical industry (Biotech/small pharma experience preferred).
• Experience in rare disease and/or liver disease is a plus.

Knowledge, Skills and Abilities:

• Strong ability to communicate effectively with team members creating an environment that fosters successful teamwork, collaboration and cooperation.
• Thorough understanding of clinical trial management processes and the operation of all clinical development functional areas.
• Demonstrated ability to prepare timelines and present related information to management.
• Proven ability to identify risks, propose mitigation strategies, and remove barriers to success.
• Strong attention to detail and the ability to work collaboratively with Project Lead to establish priorities for team.
• Expertise in developing and managing project scope, deliverables, risks and resource requirements.
• Strong knowledge of project management software packages and the Microsoft Office Suite: Excel, Project, PowerPoint, Word and Outlook; ability to create effective presentations for internal and external use.
• Ability to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands, across time-zones, while maintaining positive attitude.
• Ability to work independently, take initiative, complete tasks to deadlines and support product team in doing the same.
• Excellent written and oral communication skills.
• Displays a high level of professionalism with internal and external stakeholders.
• Knowledge of current regulatory requirements and guidelines governing clinical research. (e.g. ICH/GCP).

The salary range for this position is $195,084 to $225,217 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.

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