Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults.  Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.

POSTION SUMMARY 

This position will require the individual to be located in the NORTH CENTRAL United States.

The medical science liaison (MSL) is a field-based Medical Affairs professional who is primarily responsible for establishing and maintaining relationships with thought leaders and other healthcare professionals (HCPs) as well as engaging in scientific exchange in their assigned territory. This individual will also serve as a scientific resource and scientific expert in the support of medical affairs and related activities such as medical congress staffing, advisory boards and cross-collaborative initiatives.

JOB FUNCTIONS/RESPONSIBILITIES

• Identifies, can gain access to, and develops professional relationships with thought leaders and other healthcare professionals, active and potential study investigators, and professional organizations within their assigned geography
• Supports research initiatives across development and provides support to clinical site investigators
• Serve as a liaison between HCPs who express interest in conducting investigator-initiated research to facilitate review and consideration of research proposals
• Engages in scientific exchange in response to thought leader requests
• Can effectively articulate relevant scientific and clinical information relative to the therapeutic area to HCPs and researchers
• Utilizes scientific resources to deliver impactful presentations to varying audiences and in a variety of different settings including (but not limited to) advisory boards, patient advocacy groups, and payors
• Provides accurate and unbiased assessment of community needs to senior management
• Within PhRMA guidelines, supports company-sponsored research, investigator-initiated research, and publications.
• Supports planning and execution of advisory boards
• Stays abreast of emerging scientific literature and clinical data
• Supports the congress and conference strategy, providing scientific support and communication of scientific insights
• Fully compliant with all company SOPs, regulatory requirements, and applicable laws including PhRMA guidelines for field-based employees
• Completes other responsibilities in a timely manner, as assigned

QUALIFICATIONS

Education and Experience:

• Advanced science or clinical degree (e.g. MD, DO, Pharm.D., PhD, NP, PA)
• 5+ years field Medical Science Liaison experience preferred
• Rare disease experience or prior experience in hepatology and/or gastroenterology preferred

Knowledge, Skills, and Abilities:

• Ability to understand and effectively communicate scientific information
• Strong oral, written, and communication skills
• Able to travel frequently, up to 60% overnight travel and has a valid drivers’ license
• Advanced computer skills (MS Office, Word, Excel, PowerPoint) and willingness to learn new applications
• Excellent organizational skills
• Strong business acumen
• Launch experience preferred

To apply, please send your resume to careers@mirumpharma.com.

Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults.  Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.

POSTION SUMMARY 

This position will require the individual to be located in the NORTH EAST  United States.

The medical science liaison (MSL) is a field-based Medical Affairs professional who is primarily responsible for establishing and maintaining relationships with thought leaders and other healthcare professionals (HCPs) as well as engaging in scientific exchange in their assigned territory. This individual will also serve as a scientific resource and scientific expert in the support of medical affairs and related activities such as medical congress staffing, advisory boards and cross-collaborative initiatives.

JOB FUNCTIONS/RESPONSIBILITIES

• Identifies, can gain access to, and develops professional relationships with thought leaders and other healthcare professionals, active and potential study investigators, and professional organizations within their assigned geography
• Supports research initiatives across development and provides support to clinical site investigators
• Serve as a liaison between HCPs who express interest in conducting investigator-initiated research to facilitate review and consideration of research proposals
• Engages in scientific exchange in response to thought leader requests
• Can effectively articulate relevant scientific and clinical information relative to the therapeutic area to HCPs and researchers
• Utilizes scientific resources to deliver impactful presentations to varying audiences and in a variety of different settings including (but not limited to) advisory boards, patient advocacy groups, and payors
• Provides accurate and unbiased assessment of community needs to senior management
• Within PhRMA guidelines, supports company-sponsored research, investigator-initiated research, and publications.
• Supports planning and execution of advisory boards
• Stays abreast of emerging scientific literature and clinical data
• Supports the congress and conference strategy, providing scientific support and communication of scientific insights
• Fully compliant with all company SOPs, regulatory requirements, and applicable laws including PhRMA guidelines for field-based employees
• Completes other responsibilities in a timely manner, as assigned

QUALIFICATIONS

Education and Experience:

• Advanced science or clinical degree (e.g. MD, DO, Pharm.D., PhD, NP, PA)
• 5+ years field Medical Science Liaison experience preferred
• Rare disease experience or prior experience in hepatology and/or gastroenterology preferred

Knowledge, Skills, and Abilities:

• Ability to understand and effectively communicate scientific information
• Strong oral, written, and communication skills
• Able to travel frequently, up to 60% overnight travel and has a valid drivers’ license
• Advanced computer skills (MS Office, Word, Excel, PowerPoint) and willingness to learn new applications
• Excellent organizational skills
• Strong business acumen
• Launch experience preferred

To apply, please send your resume to careers@mirumpharma.com.

Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults.  Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.

POSTION SUMMARY 

This individual will be responsible for supply chain planning including S&OP, forecasting, development and monitoring of the Master Production Schedule as driven by the forecast, bills of material (BOMs) creation and costing analysis with accurately costed BOM’s and identify variance or cost leakage/yield loss. S/he will develop, in conjunction with Finance and Legal standard terms and conditions for PO’s as well as creating contract template documents to support normal operations. S/he will assume responsibility for Service Agreement support, to ensure proper contract terms, cost and PO alignment and vendor relationship support. S/he will be responsible for material risk mitigation and replenishment strategies. S/he will be responsible for working with Finance to review invoices and track work outstanding on PO’s. Additionally, s/he will support Engineering programs with capital equipment contracting and purchasing needs. S/he will be responsible for the setup and coordination of freight and logistics providers to deliver components and finished products in a timely and cost competitive manner. S/he will work in partnership with the Supply Chain team to mentor and train staff members in best in class supply chain planning methodologies and techniques.

The ideal candidate will have 5 – 7 years’ experience working in a Purchasing, Planning, and Logistics role in a Life Sciences, Biotech, or Medical Device company.

JOB FUNCTIONS/RESPONSIBILITIES

• Plans, schedules, and monitors the movement of materials through the production cycle to determine required materials
• Purchases materials, using engineering and production schedules to maintain inventory at planned levels
• Checks requisitions, obtains quotes, examines bids and makes awards
• Develops Specifications for new contract orders
• Obtains materials, components and equipment
• Evaluates vendor reliability by tracking metrics
• Develops new supply sources in which current vendors and suppliers are inadequate.
• Monitors cost, schedule and scope of assigned subcontracts to ensure best quality at best value
• Handle shipment logistics of purchased components and finished goods through cost effective methods including international customs and freight
• Manufacturing master planning, including issuing forecasts and scheduling
• Inventory tracking and management support at vendors and 3PL
• Vendor relationship support
• Purchasing contract process and template development ownership
• BOM costing analysis and updates, including cost savings opportunity identification
• Service Agreement support
• Capital purchasing support
• Support new product launch and key research programs with purchasing and materials planning
• Dual/second sourcing opportunity development
• Conduct vendor supply risk assessment & contingency planning

QUALIFICATIONS

Knowledge, Skills, and Abilities:

• A minimum of 5 years’ experience in a procurement and planning role, preferably in a Life Science, Biotech, or Medical Device company
• Proficient in the fundamentals of manufacturing BOM’s
• Proficient in the use of Excel and database applications
• Experience with Life Science/Biotech equipment maintenance and manufacturing agreements
• Experience working with contract manufacturers
• Experience with contract development and negotiations
• Experience developing RFP or RFQ’s
• Strong communicator with ability to maintain open communication with internal employees, managers and suppliers as needed
• Able to integrate and apply feedback in a professional manner
• Ability and willingness to work as part of a team and to support the materials warehouse team

Desired:

• Bachelor’s degree, or equivalent
• APICS Coursework; Certification, a plus
• Experience in custom capital equipment procurement, a plus
• Experience developing contract and other business transactional templates
• Experience developing custom purchasing specifications
• Knowledgeable in ERP/MRP planning systems
• Experience with US and International Customs requirements and procedures

Work Requirements:

• Travel Requirements: approximately 15 – 20%
• Some lifting (greater than 25 pounds) may be necessary; may occasionally lift at least 50-75 pounds

To apply, please send your resume to careers@mirumpharma.com.

Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults.  Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.

POSTION SUMMARY 

As the Manager International Accounting for the accounting team, you’ll work closely with the Assistant Controller to oversee and manage the accounting activities for our foreign subsidiaries. This is a newly created position to address our expanding foreign operations and requires a thorough understanding of consolidations, foreign currency translation and intercompany transactions. In addition, you will be responsible for the accounting of our global manufacturing and supply chain activities. You will utilize your existing accounting skills and knowledge, learn new skills, and play a key role as a member of our growing finance and accounting team.

JOB FUNCTIONS

• Oversee and manage the accounting activities for foreign subsidiaries, including intercompany sales, royalties, service agreements and currency translation
• Ensure compliance with international accounting policies, procedures, and controls for international legal entities.
• Work with local accounting teams to ensure that transactions are accurately and timely recorded in the local financial statements as well as the financial statements of the parent company.
• Manage the monthly close process for the international offices, including the review of financial reporting packages, preparation and recording of journal entries, and maintenance of foreign exchange.
• Assist in the consolidation of international subsidiaries
• Assist with transitioning the foreign accounting activities to NetSuite to create an integrated global financial reporting system
• Perform accruals for all outsourced global manufacturing and supply chain activities
• Assist with the monthly close process including account reconciliations/analyses for balance sheet and income statement accounts
• Asist with flux analyses to ensure that all results are proper and prepared in accordance with US GAAP guidelines
• Assist with the annual audit of the consolidated financial statements and local foreign statutory audits, when required.
• Develop and document key accounting processes and controls for international offices
• Assist in preparation of US GAAP financial statements and footnotes
• Other responsibilities include, but are not limited to participating in special projects, system improvements or ad hoc analyses/projects as assigne

QUALIFICATIONS

Education/Experience:

• Strong US GAAP and international accounting experience – biotech industry, public company
• Minimum 5-7 years of experience with accounting and financial reporting, public auditor experience (EY, Deloitte, etc.)
• Advanced knowledge of accounting for foreign subsidiaries and consolidations
• Advanced knowledge of Microsoft Office Suite, especially Excel
• Hands-on experience in managing general ledger related functions, including familiarity with accounting software such as NetSuite or similar (NetSuite experience with consolidation and foreign currency reporting a plus)
• Bachelor or master’s degree in accounting
• Public company experience preferred
• Biotech research and development accounting experience preferred
• CPA preferred 

Knowledge, Skills and Abilities:

• A sense of ownership and pride in your performance and its impact on the company’s success
• A positive, self-confident and decisive work ethic with excellent communication skills in both oral and written formats, as well as excellent listening skills
• Self-motivated and self-managed – able to think independently and creatively
• Ability to build and scale processes with strong analytical skills
• Strong understanding of internal controls and SOX compliance.
• Energy to commit to a fast-paced environment
• Must be detail oriented yet not lost in the details
• A team player and able to support other departments to achieve objective

To apply, please send your resume to careers@mirumpharma.com.

Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults.  Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.

POSTION SUMMARY 

The Senior Manager, Patient Services, supports Market Access business objectives by executing a dynamic set of programs and services that support drug access and adherence for patients and prescribers.  The Senior Manager will be the primary individual responsible for managing operational excellence with our patient services vendor(s).  The Senior Manager will work across the organization and commercial functions to ensure patient services enhancements are made in alignment with commercial brand strategy.

JOB FUNCTIONS

• Oversee execution of Patient Services vendor(s) and teams, by troubleshooting and providing current guidance and expertise to support program workflow and services
• Manage vendor performance using agreed upon metrics and standards, call monitoring, site visits, and program audits
• Provide investigation and response to internal and external customer issues and complaints while concurrently instituting necessary improvements to avoid recurrence
• Support execution of all communications from Patient Services to our customers, including obtaining Legal and/or MLR approval of all communications to healthcare professionals and patients
• Draft, review, and approve standard operating procedures (SOPs), work instructions, and job aids, as needed, to support Mirum Access Plus compliance and operations
• Organize business reviews with vendor(s) to gain insights from Patient Services programs and ensure communication of key performance metrics and operational insights to internal stakeholders
• Implement new enhancements required to support current and future products by performing ongoing analysis of existing operations to ensure optimal productivity, superior customer service, exceptional product coverage, and patient engagement
• Work in collaboration with Market Access, Legal, Compliance, Regulatory, Medical, Advocacy, Marketing, Commercial Operations, and Sales as necessary to ensure compliance and effectiveness in our programs
• Other duties as assigned

QUALIFICATIONS

Knowledge, Skills and Abilities:

• Must demonstrate expertise in call center operations, systems, and processes related to patient services
• Knowledge of applicable legal and regulatory issues that pertain to patient support programs
• Demonstrated effective problem solving, excellent customer service, and knowing when to escalate in a challenging and fast-paced environment
• Experience implementing complex programs that require process and software development, data integration and ongoing quality improvement
• Demonstrated ability to manage multiple projects within specified timelines and quality standards
• Proven track record for consistently meeting or exceeding qualitative, as well as any relevant quantitative, targets and goals
• Ability to work collaboratively in a team structure and build strong relationships with internal and external stakeholders
• Ability to travel up to 20% of the time for direct engagement with Patient Services vendors

Education/Experience:

• Bachelor’s degree or greater (general business, health sciences, managed healthcare, public policy or related disciplines are preferred)
• 8+  years of related experience in the commercial pharmaceutical industry with specialty products required
• Demonstrated ability, or potential, to thrive in smaller entrepreneurial organizations
• Experience with electronic document control/management systems; Veeva PromoMats is preferred
• Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint

To apply, please send your resume to careers@mirumpharma.com.

Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults.  Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.

POSTION SUMMARY 

Provide leadership and support in the planning, development, and execution of commercial supply chain activities for Partner and Distributor markets.  The successful candidate will demonstrate leadership ability, end-to-end commercial supply chain expertise, be able to work independently and enjoy working in a dynamic, complex, fast-paced environment during a period of significant growth.

JOB FUNCTIONS/RESPONSIBILITIES

• Direct supply chain management activities for Partner and Distributor markets
• Partner with VP Supply Chain to develop a global S&OP planning process to ensure we are meeting worldwide demand for both early access programs and commercial readiness.  Align production requirements internally with CMC, Quality, and Supply Chain counterparts and own communication of supply to partner and distributor markets
• Co-lead negotiation efforts for major contracts and global distribution agreements
• Good knowledge of global regulatory requirements that may impact Mirum’s supply chain and ability to supply ex-US markets
• Optimize 3PL global footprint for worldwide distribution
• Partner with VP Supply Chain to develop business continuity models to mitigate the end-to-end supply chain for Mirum’s products
• Manage POs, Change Orders and spend for CPOs and 3PLs
• Develop associated SOPs and WIs for inventory management, distribution, and recalls
• Oversee trade compliance for global commercial product distribution for full compliance with all local and international requirements and regulations
• Initiate and manage high value intercontinental shipments
• Support new products and product improvements (potential combination products) by participating in cross functional core teams, including responsibility for infrastructure and documentation

QUALIFICATIONS

Education/Experience:

• B.A./B.S. preferred
• 12+ years of experience in pharmaceutical operations and supplier management functions
• Must have previous experience with pharmaceutical, commercial supply operations, preferable in a supply company
• Successful vendor management experience
• Experience in a biotech or biopharma environment
• Proven understanding of global pharmaceutical distribution requirements
• Proven experience of global pharmaceutical regulatory / registration requirements
• Experience establishing pharmaceutical supply chain systems and networks are essential
• Experience with cold chain would be beneficial

Knowledge, Skills, and Abilities:

• Proven ability to lead complex contractual negotiations with a deep understanding of financial considerations when it comes to procurement and supply chain
• Understands and wants to work in a small company environment and is a “doer”
• Proactive, shows good judgement, anticipates future consequences, and can make decisions decisively in the face of ambiguity
• Can apply knowledge to new situations
• Creates a sense of partnership with vendors but can be direct when needed
• Can work collaboratively maintaining the ‘team spirit’ with other functional areas
• Thinks outside the box and can come up with creative solutions when faced with challenges.  Ability to flex and adapt to complex and changing strategy/deliverables
• Can prioritize (and quickly re-prioritize as needed) and multi-task
• Not afraid to speak up when there is a better way to do something
• Has integrity, honesty, conscientiousness, is team-oriented and willing to jump in wherever needed and organized

To apply, please send your resume to careers@mirumpharma.com.

Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults.  Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.

POSTION SUMMARY 

Provide strategic, managerial, and technical leadership to a small team of internal analytical scientists in a fully out-sourced environment as well as provide scientific input to scientists from CMOs and CTLs as needed.

JOB FUNCTIONS/RESPONSIBILITIES

• Establish strategic plans and provide leadership to ensure priorities are met in a fast-paced environment.
• Proactively identify analytical gaps and deficiencies and initiate mitigation strategies across programs.
• Apply technical and management expertise to meet project goals and timelines, and to make technical and management decisions to keep projects on track.
• Select, oversee, and continuously assess CMOs/CTLs. Manage and oversee review of raw data packages associated with method qualifications/validations, release testing, stability testing, and other characterization testing of drug substances and drug products.
• Support relevant vendors (CMOs/CTLs) during the development and characterization of the drug substance and drug product. Travel to CMOs and CTLs as needed.
• Ensure the timely preparation, review, and approval of technical reports, monographs, appropriate sections of regulatory drug submissions, etc.
• Work closely with Manufacturing, Regulatory, and Quality groups to support technology transfers and regulatory submissions with appropriate documentation.
• Ensure the development of quality processes that comply with ICH guidelines; work with QA to assure high quality is maintained and a strong quality system is developed around the drug substance and product.
• Work within budget and provide functional input into yearly budgets and long-range plans.

QUALIFICATIONS

Education/Experience:

• Ph.D. in Chemistry, Pharmaceutical Sciences, or Pharmaceutics or relevant industrial experience in CMC with a major pharmaceutical or generic pharmaceutical company.
• Knowledgeable in analytical techniques such as HPLC, GC, FTIR, UV-Vis, KF, and other USP and EP methods with hands on experience and expertise with analytical techniques and troubleshooting instrumentation.
• Working knowledge of phase-appropriate cGMP requirements, ICH, FDA, USP, EP and other pharmaceutical industry regulatory guidelines.
• Meticulousness with details while able to see “big picture”. Proven ability to multi-task, be flexible, make decisions, and handle multiple projects simultaneously.
• Previous active participation in contributing to company Quality Systems and writing and reviewing of departmental SOPs.
• Sound understanding of CMC regulatory requirements and direct experience with compiling CMC sections for INDs, NDAs, and MAAs and responding to regulatory queries.
• Experience with regulatory interactions and inspections.
• Team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment.
• Strong ability to communicate effectively with team members creating an environment that fosters successful teamwork, collaboration, and cooperation.
• Experience in a small company environment strongly preferred. Ability to work in a fast-paced virtual environment with demonstrated ability to juggle multiple competing tasks and demands while maintaining positive attitude.

To apply, please send your resume to careers@mirumpharma.com.

Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults.  Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.

POSTION SUMMARY 

The Associate Director, Program Management (International) will partner with the International team functional leads to develop and manage the integrated plan for the international activities including supporting strategy, developing timelines, coordinating the execution of international activities both internally and with partners/distributors, and ensuring adherence to the budget for one of our cholestatic liver disease programs. 

JOB FUNCTIONS/RESPONSIBILITIES

• Supports the international team with setting and the timely execution of the international strategies and plans including development, manufacturing and commercial
• Develops and maintains integrated international program timelines and budget in conjunction with functional leads
• Tracks deliverables until completion; escalates issues raised by the functional leads, as needed
• Identifies and communicates priorities and critical path activities to international team
• Identifies activity interdependencies, proactively identifies potential risks and issues, and sets mitigation plans in conjunction with functional leads
• Coordinates internal functions to ensure appropriate resources for partner/distributorship success and for early identification of resourcing constraints
• Manages effective and efficient international team meetings including scheduling, setting agenda, ensuring status reports completed on schedule, drafting minutes, and following up on action items until resolution
• Aligns different ways of working across collaboration partners and distributors to ensure efficient international team operations
• Plans, schedules and facilitates partner/distributor working group meetings
• Partners closely with alliance management by providing international team insights to optimize partnership interactions, ensuring practical and effective structure with partners/distributors, and for early escalation of alliance issues
• Represents International team at Product Team meetings
• Partner with accounting to manage international budget including ensuring accurate and timely accruals, identification of out of scope activities, and early identification of potential budget variances
• Coordinate and manage special program-related projects, as assigned
• Contributes to the standardization of project management best practices at Mirum

QUALIFICATIONS

Education/Experience:

• Bachelor’s Degree or higher in scientific/healthcare/business field
• Experience (5+ years) in clinical development or pharmaceutical commercial operations and project management (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 development and/or pharmaceutical commercial operations
• Demonstrated ability to prepare timelines and present related information to management.
• Demonstrated ability to create and manage budgets including communication of overspend/underspend.
• Proven ability to identify risks, propose mitigation strategies, and remove barriers to success.
• Strong attention to detail and the ability to work collaboratively with international team leads to establish priorities for team.
• 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 development. (e.g. ICH/GCP/GMP).

To apply, please send your resume to careers@mirumpharma.com.

Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults.  Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.

POSTION SUMMARY 

The Associate Director/Senior Manager will provide leadership and support in the planning, development, and execution of clinical supply chain activities for several clinical studies/programs in various phases. A successful candidate will demonstrate leadership ability, end-to-end clinical supply chain expertise (managing all aspects of clinical supplies in a global trial setting), be able to work independently and enjoy working in a dynamic, fast-paced environment during a period of significant growth.

• Review clinical protocols and translate clinical study requirements into demand for clinical trial materials (including medical devices and/or ancillaries as required) for supporting multiple global clinical studies
• Manage all clinical supply activities for on-time delivery, which includes demand forecasting, trial monitoring & resupply planning, packaging/distribution, Interactive Response Technology (IRT) set-up and distribution activities
• Strategically manage procurement, packaging, labeling, distribution, returns, reconciliation, destruction and storage tasks for all clinical trial materials (including medical devices and/or ancillary as required)
• Review and approve documentation related to packaging, labeling, and distribution of clinical trial materials. Maintain appropriate documentation in compliance with domestic and international regulations
• Author cGMP documentation including change controls, deviation reports, and SOP’s as required
• Manage clinical trial materials distribution and logistics for global clinical programs, including importing and exporting clinical supplies
• Support the procurement, labeling and distribution of comparators
• Work collaboratively with CMC, Clinical Operations, Quality Assurance and Regulatory Affairs to develop supply strategy to maximize supply efficiency, minimize waste, and develop risk mitigation plans to proactively identify any potential issues that may impact drug supply
• Work with the clinical team to configure and set up Interactive Response Technology (IRT) Systems including automated randomization and drug supply management, including specification design & UAT testing
• Manage study closeouts and drug reconciliation at study end
• Develop and manage clinical supply budget and negotiate contracts with vendors

Qualifications:

Education:

• Requires a BS degree with a minimum of 5 years’ experience in a clinical supply chain management role in a biotechnology/pharmaceutical industry

Experience:

• Experience managing contract packaging and labeling organizations (strongly preferred)
• Experience with developing risk-based Clinical Trial Supplies management from early to late phases international clinical studies (double-blind, comparator)
• Manage vendor oversight activities and vendor performance to ensure high quality, cost effective execution of outsourced clinical supply activities
• Detailed understanding of regulatory requirements for clinical supply distribution in US, APAC, and EU including testing and labeling requirements
• Detailed understanding of regulatory and Good Manufacturing Practices and Good Distribution Practices requirements for IMP supply and national/international transportation requirements for pharmaceutical materials
• Global distribution experience including working with QP, IXRS and regional depots
• Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient
• Excellent project management and communication skills
• 10 to 15% travel may be required (including international travel)

To apply, please send your resume to careers@mirumpharma.com.

Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults.  Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.

JOB FUNCTIONS / RESPONSIBILITIES

Reporting to the Executive Director of Financial Planning and Analysis the Senior Finance Manager will be responsible for:

• Partnering with Finance, Accounting and Operating teams to provide clear and consistent financial management information for R&D and G&A managers.
• Working with Clinical leaders to build and manage detailed budgets and forecasts.
• Acting as organization “power user” and system administrator of TM1 planning tool.
• Providing financial transparency for management through developing and delivering financial reporting at the company, department, project and transaction level.
• Organizing and analyzing data queries to translate general ledger transactional data into meaningful business operational information.
• Partner with FP&A leader on collaboration and partnership financial management.
• Participating with FP&A team on all forecasting, budgeting and long-range planning.
• Work with Finance organization to enable and assist:
• Month-end financial accrual processes.
• Quarterly financial review and reporting of variances associated with period over period trends; budget and forecast

QUALIFICATIONS

• Bachelor Degree with post-graduate degree preferred.
• 5-7 years professional work experience in financial role, including bio-pharma.
• Strong understanding of corporate accounting, financial management practices, data management and analytics.
• Strong communication and collaboration interpersonal skills.
• Past record of effective execution in process management involving challenges, timelines, and prioritization.
• Agile, flexible and familiar with fast paced company environment.
• Advanced knowledge and experience with Microsoft products, IBM-TM1 and NetSuite.
• Hands-on experience building multi-dimensional financial business models.
• Experience with Clinical Trials, TM1 system, or Collaboration Finance highly desired

To apply, please send your resume to careers@mirumpharma.com.