Senior Director, Program Management
Mirum Pharmaceuticals Inc. job in Foster City, CA
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
We are seeking a strategic and operationally-savvy leader to oversee and drive the program management function at Mirum, building best-in-class program management practices and strategic approaches to drive results. This leader will have responsibility for establishing program-related processes, systems, and templates to enable portfolio-level oversight and decision-making. They will lead and mentor a team of program management professionals and foster strong partnerships across internal teams to ensure program success and maximize portfolio value.
JOB FUNCTIONS/RESPONSIBILITIES
* Lead a high-performing Project Management Office that supports strategic planning and execution across all development programs.
* Establish and manage program governance to enable prioritization of resources and activities including the facilitation of annual operating plan process in conjunction with FP&A.
* Develop, implement and continuously refine PMO processes, frameworks and tools (e.g., timelines, stage-gates, communication plans, resource planning, budgeting, decision-making, etc.).
* Serve as a strategic partner and communicator with senior leadership: provide program status, decision-support, trade-offs, and portfolio linkage.
* Facilitate decision-making processes, including risk mitigation strategies and scenario planning.
* In partnership with program managers, identify key hurdles across programs.
* Identify, assess and proactively mitigate portfolio-level program risks and dependencies; escalate issues appropriately.
* Maintain continuous communication with Program Leads to ensure timely support and proactive involvement in program dynamics and team performance.
* Drive cross-functional collaboration: align stakeholders (clinical, regulatory, CMC, finance, commercial) around program strategy and deliverables.
* Mentor and develop program managers, fostering a culture of accountability, innovation, and continuous improvement.
* Coach and mentor PT members on their roles, team interactions, program deliverables & interdependencies, action plans, presentations (executive style) to senior management
* Actively resolve issues and elevate concerns with a sense of urgency to promote a culture of rapid improvement and responsiveness.
* Serve as the Program Manager for one of Mirum's programs or during corporate development evaluation of potential new assets, as needed
QUALIFICATIONS
Education/Experience:
* Bachelor's degree in life sciences, engineering or related field required; advanced degree (MS, PhD, MBA) strongly preferred.
* 10+ years of experience in the biotech or pharmaceutical industry, with substantive exposure to drug (or biologic/therapy) development.
* Demonstrated portfolio and program management experience with cross-functional and global teams, including milestone budget/resourcing management.
* Previous experience building a PMO is a plus.
Knowledge, Skills and Abilities:
* Deep understanding of the therapeutic development lifecycle, including non-clinical, clinical, CMC/manufacturing, regulatory and commercial interface.
* Excellent leadership, communication and interpersonal skills: ability to influence without direct authority, build relationships across functions and navigate matrix environments.
* Strong analytical and problem-solving capabilities; comfortable with ambiguity and dynamic change.
* Familiarity with program management tools and frameworks (e.g., MS Project, Smartsheet, stage-gate process).
The salary range for this position is $290,000 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.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Senior Clinical Project Manager
Mirum Pharmaceuticals Inc. job in Foster City, CA
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
The role will be responsible for 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. Manages selected CROs and leads cross-functional project teams (clinical monitoring, data management, biostatistics, medical writing, medical affairs, regulatory affairs, and clinical QA) to ensure the project 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.
* Establish communication plans for information distribution to team members.
* Manage project/program meetings.
* Conduct project/program reviews at significant milestones or gates to evaluate successes as compared to baseline estimates.
* Integrate understanding of constraints across and within projects and recommend alternatives.
* Identify and track key study metrics in order 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 regulatory submission preparations.
* Author/Oversee the development of plans and execution of those plans related to project management, site monitoring, safety management, data management and biostatistics.
* Identify, evaluate, and select 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.
* Perform periodic visits to sites and/or CROs to assess the progress of studies/protocol compliance. Develops/reviews and approves study plans.
* Develop contracts for and perform ongoing management of vendors to ensure deliverables and performance adhere to contract.
* Oversee the identification, selection, and proper initiation of sites.
* Develop patient recruitment strategies to ensure enrollment goals are achieved
* Oversee development of CRFs, and clinical databases, support development of safety databases, and shell Tables, Figures and Listings.
* Plan, coordinate, and conduct investigator meetings.
* Contribute to planning, coordination and conduct of Data Monitoring Committee (DMC) meetings.
* With Medical and Safety, assess trends in data including adverse events, protocol violations, etc.
* Oversee timely database freeze and database lock. Participate in data review meetings.
* Oversee maintenance of the Trial Master File for each project and oversee the archival process.
* Ensure adherence to SOPs, GCP and 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 experience as a global clinical project manager.
* Experience in rare disease preferred.
* Experience working in a fully outsourced model.
* Experience in small, fast-paced biotech is a plus.
* 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 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, as well as CROs
* Ability to work with minimal supervision, take initiative and complete tasks to deadlines, and resolve/escalate 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 growing 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 $190,000 to $205,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Senior Quality Auditor
Mirum Pharmaceuticals job in Foster City, CA
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
The position will serve as the primary auditor for GCP/GLP/GCLP/GVP audits. Further this position will draft, review and approve audit reports as well as managing audit responses and CAPA, as applicable. This position will assist with collecting data, establishing metrics, and performing tracking and trending of audit activities, and supporting the vendor audit management program. The position will be responsible for contributing to applicable SOP revisions for the Quality Compliance team and assist with the maintenance of the eQMS system as it relates to audit management as applicable.
JOB FUNCTIONS/RESPONSIBILITIES
• Act as Quality Auditor Lead on GCP/GLP/GCLP/GPV Audits by performing Internal and External Vendor Audits as scheduled
• Support development of audit management plans and audit strategy for ongoing Internal and Vendor Audits
• Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documented
• Support or conduct training for staff (GCP, GLP, GCLP, GPV)
• Support both Regulatory Inspections and Partner Audits of Mirum as needed.
• Review/revise Standard Operating Procedure (SOPs) and procedures as assigned.
• Support the day-to-day activities of the audit programs, including but not limited to audit coordinating, report reviews, response review, CAPA follow-up, and audit close-out as needed.
• Gather data for accurately tracking, reporting, and analyzing metrics, as required.
• Supports GxP inspection readiness activities, as applicable.
• Other Duties as assigned
QUALIFICATIONS
Education/Experience: Bachelor's degree in a scientific discipline
Knowledge, Skills and Abilities:
• Minimum 10 years' experience in Quality Audits and/or experience in supporting GCP/GLP/GPV/GCLP audits and activities in the drug development industry with knowledge of FDA, EMA, MHRA and other applicable global regulations. Experience with other GxP (GMP, GDP) audits and regulations is a plus.
• Excellent verbal and written communication skills.
• Demonstrated ability to influence across the organization.
• Successful experience writing and reviewing SOPs and other Quality documents.
• Thorough understanding of quality systems that support internal GxP activities for pre-clinical, clinical and commercial products.
• Demonstrated ability to successfully interact with regulatory health authorities during inspections.
• Thorough understanding of audit programs.
• Excellent organizational skills with ability to manage multiple tasks of varying complexity simultaneously.
• Strong interpersonal skills including relationship building, and conflict resolution
• Experience with Veeva platform systems is a plus.
• Ability and willingness to Travel Domestically and Internationally up to 40 to 50% of time.
The salary range for this position is $190,000 to $200,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Auto-ApplyPatient Navigator
Mirum Pharmaceuticals job in Foster City, CA
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
Position Summary
Are you someone who has the proven ability to thrive in a dynamic, evolving environment and contribute to building new capabilities in healthcare. We're seeking an empathetic, detail-driven Patient Navigator to join our growing rare disease team. In this pivotal role, you'll serve as the primary liaison for patients, caregivers, and healthcare providers, ensuring a seamless experience from prescription to ongoing therapy. You will provide inbound and outbound phone support and serve as the primary contact for patients, caregivers, and providers. You will facilitate a collaborative process that gauges, coordinates, and monitors patient need and appropriately facilitates a patient's journey utilizing services offered through the Patient Support Program on behalf of Mirum and coordination with our specialty pharmacy partner. You'll work closely with the specialty pharmacy, reimbursement specialists, and internal partners to make sure patients receive their medications on time, every time. The outcome of your efforts will be to provide unparalleled customer service to patients, caregivers and providers.
If you have a nursing or case management background, you can thrive in a fast-paced biotech environment and are passionate about helping patients with rare diseases navigate complex access barriers-this is the opportunity for you.
Key Responsibilities
Serve as the main point of contact for patients and caregivers, providing non-clinical guidance and emotional support throughout their treatment journey demonstrating a thorough understanding of the disease state and Mirum product profiles.
Provide patients and HCPs a clear understanding of eligibility requirements, program enrollment, reimbursement process, affordability support, and general access for Mirum prescribed therapies.
Deliver unparalleled customer service while serving as a brand advocate and program representative; understands the importance of achieving quality outcomes and commit to the appropriate use of resources
Coordinate care between prescribers, specialty pharmacies, and insurance providers to ensure timely drug access and refills.
Monitor patient cases to identify potential delays or issues (e.g., prior authorizations, benefit revalidations, prescription renewals) and proactively resolve them.
Educate patients and families about program resources, refill schedules, and financial assistance options.
Elevate the patient experience by partnering with Mirum's market access, reimbursement, and specialty pharmacy teams to resolve coverage and dispensing challenges.
Support patient onboarding, therapy continuation, and adherence initiatives in alignment with program KPIs.
Serve as a resource for patients and healthcare professionals to verify insurance coverage, reimbursement process, and general access for complex pharmaceuticals and ability to understand and explain benefits offered by all payer types including private/commercial and government (i.e., Medicare, Medicaid, VA and DOD)
Patient Navigators will be regionally aligned and will serve as an expert on reimbursement, co-pay, foundation assistance, patient assistance program (PAP) issues, and other forms of available support and will be responsible for handling patient and healthcare provider interactions related to these topics in collaboration with the Regional Access Leads and Regional Account Managers.
Responsible for communicating insurance benefit investigations, prior authorization and appeal requirements, and triage cases according to program standard operating procedures
Serve as direct point of contact to health care providers for ongoing support and relationship development by acquiring and delivering detailed information regarding a program and/or a patient
Evaluate program enrollment forms for data integrity and missing information
Follow program guidelines and escalate complex cases according to program policy, SOPs, Call Guides, and other program materials.
Working in a case management system, documenting status/background in case notes, communicating patient benefits, assisting in the PA/Appeals process and like responsibilities
Act as an assigned liaison to customer contacts (e.g., regional contact for sales representatives), Market Access colleagues, other internal stakeholders and healthcare providers
Works with the Program Supervisor, on a day-to-day basis to maintain open lines of communication and share awareness regarding patient status, prescriber feedback/satisfaction and program effectiveness
Maintains a high level of ethical conduct regarding confidentiality and privacy.
Help maintain team morale by consistently demonstrating positive attitude.
Maintain accurate, compliant documentation within CRM and case management systems.
Conducts miscellaneous tasks or projects as assigned identify and report pharmacovigilance information as required, i.e., Adverse Events, and Product Quality Complaints
Qualifications
BA/BS Highly Desired.
Registered Nurse (RN), Licensed Practical Nurse (LPN/LVN) Social Worker (BSW), or Case Manager (CCM) preferred.
Minimum 5+ years of experience in patient navigation, specialty pharmacy, case management, or patient access preferably in biotech, rare disease, oncology or cell/gene therapy.
Strong understanding and experience in working through benefits verification, prior authorization, and reimbursement processes.
Exceptional communication, organization, and problem-solving skills that have been demonstrated in producing improved patient experiences and outcomes.
Proven ability to work independently in a high-volume, fast paced and patient-focused environment.
Empathetic and patient-centered mindset with a commitment to improving rare disease care.
Ability to multitask and balance multiple priorities at once.
Demonstrated ability to deliver meaningful & concise conversations with integrity and empathy directly to patients and health care providers
Experience using CRM or case tracking systems (Salesforce Health Cloud preferred)
In-depth understanding of health insurance benefits, relevant state and federal laws and insurance regulations.
Excellent written and oral communication, and problem-solving skills, including the ability to connect with patients, caregivers, and providers.
Experience and demonstrated success working in a complex matrix to accomplish goals with a patient centric approach.
Strong people skills that demonstrate flexibility, persistence, creativity, empathy, and trust.
Robust computer literacy skills including data entry and MS Office-based software programs.
Possesses strong business acumen and strategic thinking skills.
Ability to identify and handle sensitive issues, working independently and collaboratively within teams.
Ability to travel required, ~10%, possibly weekends.
This position is based in Foster City, CA or Charlotte, NC. Applicants must reside in a location which would allow them to comply with Mirum's hybrid work policy.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Auto-ApplySenior Associate, Medical Safety Operations
Mirum Pharmaceuticals Inc. job in Foster City, CA
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
The Senior Associate, Drug Safety in Medical Safety Operations will support vendor oversight activities with respect to the individual case safety report (ICSR) management process at Mirum.
JOB FUNCTIONS/RESPONSIBILITIES
* Perform routine retrospective quality review of the safety data collected to ensure completeness and accuracy. Collaborate with the pharmacovigilance (PV) vendor to address case corrections and trends.
* Provide case processing guidance to the PV vendor in alignment with existing Mirum standards.
* Review case metrics to ensure cases processed by the PV vendor are processed and exchanged within the agreed upon timelines.
* Oversee and support reconciliation of safety data from various sources.
* Oversee submission of expedited safety reports by the PV vendor and clinical contract research organizations; escalate and document late regulatory authority submissions.
* Generate listing from Safety Database (Argus) or OBIEE as needed.
* Responsible for interdepartmental collaboration, such as, but not limited to Quality Assurance, Clinical Operations, Regulatory Affairs on obtaining additional information as needed by PV vendor.
* Manage and/or support system access (e.g. EDC, Argus etc.) along with periodic review of user access.
QUALIFICATIONS
Education/Experience:
* Minimum of 3 years direct pharmaceutical industry experience dealing with global clinical study individual case safety report processing and reporting preferred; post-approval safety experience highly desired.
* Detailed knowledge of relevant US, EU, and ICH guidelines, initiatives and regulations governing both clinical studies and post-approval safety.
Knowledge, Skills and Abilities:
* Bachelor's degree in life sciences.
* Safety database experience is required.
* Proficient in MS Word, Excel, PowerPoint, Outlook, and other applicable business software tools.
Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Director, Clinical Operations
Mirum Pharmaceuticals job in Foster City, CA
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
The Director, Clinical Operations is responsible for providing leadership to assigned clinical program(s) and for ensuring studies within a program are being managed in accordance with the Mirum's overall program goals, timeline, budget and quality expectations. This individual is responsible for ensuring clinical trials within a clinical program comply with the company's procedures, FDA, regulations, GCP, ICH requirements and any other applicable regulations. The Director, Clinical Operations is also responsible for the development and implementation of clinical best practices for effective clinical study execution in accordance with regulations and from time to time may lead strategic and continuous improvement initiatives in clinical project execution and project management.
JOB FUNCTIONS/RESPONSIBILITIES
Provides leadership in the development of the clinical trial management, budget and resourcing strategy at a clinical program level as a Clinical Operations Program Lead.
Collaborates with the SVP, Clinical Operations, to ensure alignment of resources and budgets across clinical programs by evaluating timelines and prioritizing tasks.
Provides leadership to Clinical Projects to ensure trial/study teams, are managed in alignment with clinical program and Mirum goals.
Provides Clinical Program updates, including trial status/metrics, budget, accomplishments and risks to SVP, Clinical Operations, Program Team Leads, Program Managers, Senior Management and other relevant stakeholders.
Responsible for the strategic and operational oversight, management, execution and delivery of the clinical studies for one or more development products.
Oversight of clinical operations team in the identification of potential challenges or risks with clinical study conduct and implementation mitigation plans.
Represents the Clinical Operations at the Product Team (PT), to discuss urgent operational questions and to provide strategic operational input to the PT.
Resolves and/or escalates issues raised by the clinical operations team or the SMT.
Takes a lead role in vendor selection, including critical review of contracts and negotiation of work orders.
Oversees CROs and other selected vendors on a product level including setting and monitoring key performance indicators and ensuring successful execution of program/studies.
Acts as the main escalation point of contact for strategic CRO partner(s) for the assigned program and for the key stakeholders in clinical operations.
Ensures consistency between studies for one or more products.
Provides input and clinical operations perspective on clinical trial design.
Authors, provides input and/or oversees program level and study level documents to support clinical studies and regulatory submissions.
Oversees financial aspects of assigned clinical study(ies) including preparing departmental level operating plans and ensuring adherence to planned study budgets.
Provides direction for strategic initiatives/oversees implementation of those initiatives for process and operational improvements.
Oversees/co-leads inspection readiness activities and acts as subject matter expert during regulatory inspections.
Works closely with Quality Assurance on SOP development.
QUALIFICATIONS
Education/Experience:
Advanced Degree in Scientific/healthcare field preferred.
Significant experience (10+ years) of clinical research and organizational management within the pharmaceutical industry (Biotech/small pharma experience preferred).
Global clinical trial research experience.
Experience leading cross functional teams.
Experience in rare disease and/or liver disease is preferred.
Knowledge, Skills and Abilities:
Demonstrated ability to present complex information to management, vendors and external audiences.
Demonstrated ability to create and manage one or more program budgets including communication of overspend/underspend
Ability to manage and communicate effectively with vendors including negotiating contracts, drafting and reviewing request for proposals, analyzing scope of work, responding to inquiries and complaints.
Strong attention to detail and the ability to establish priorities for team.
Ability to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands, across time-zones.
Ability to work independently, take initiative, complete tasks to deadlines and support Clinical operations team in doing the same.
Demonstrated ability to lead, motivate and mentor staff and teams.
Excellent written and oral communication skills.
Displays a high level of professionalism with internal and external stakeholders.
Proven ability to remove barriers to success.
Detailed knowledge of current regulatory requirements and guidelines governing clinical research.
Previous line management or direct management of team members.
Strong knowledge of applicable computer and project management software packages.
Has in-depth knowledge of global regulatory/industry guidelines (e.g. ICH/GCP).
The salary range for this position is $233,000 to $243,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Auto-ApplyDirector, Healthcare Compliance
Mirum Pharmaceuticals job in Foster City, CA
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSTION SUMMARY
The Director, Healthcare Compliance is responsible for the support and continual development of Mirum's comprehensive compliance program to help ensure that the Company meets its ethical and legal obligations to patients, healthcare professionals, employees, investors and other stakeholders.
****This role does require you to be in the Foster City office. We are offering relocation.***
JOB FUNCTIONS/RESPONSIBILITIES
Lead and manage all aspects of federal and state transparency (Sunshine Act/Open Payments and similar state requirements) and aggregate spend reporting requirements.
Monitor and analyze data for trends, anomalies and compliance gaps.
Manage ongoing development and execution of Mirum's risk-based auditing and monitoring program to ensure compliance with applicable laws, regulations and company policies.
Work with third-party vendors and internal stakeholders to ensure compliance with state licensing, registration and renewal requirements.
Manage continual development and implementation of Mirum's compliance policies.
Champion Company culture in which employees view compliance as aligned with core values and regard it as a key objective in business decisions and process development.
Partner with legal, regulatory, finance, quality and other departments to support compliance-related initiatives and resolve operational compliance issues.
Assist with ongoing management of training curriculum and healthcare compliance training as needed.
Assist with investigations regarding matters of observed, reported or suspected non-compliance and collaborate with functional heads as needed toward implementing necessary corrective actions.
Support Privacy initiatives for HIPAA and GDPR compliance as needed.
Represent Mirum in industry compliance forums.
Participate in ride-long monitoring activities as needed.
QUALIFICATIONS
Education/Experience:
Bachelor's degree required; advanced degree preferred.
Minimum 7 years of US healthcare compliance experience in a biotech/pharma organization.
Demonstrated operational compliance expertise, including hands-on experience with transparency reporting, auditing/monitoring and training.
Familiarity with state and federal licensing and registration requirements.
Experienced in the development, initiation, maintenance, and enforcement of policies and procedures for the operation of a Compliance Program.
Demonstrated collaborations working with senior business leaders, attorneys, law enforcement professionals, and regulators.
Experience in supporting investigations and managing the investigative process.
Rare disease commercial launch experience preferred but not required.
Systems implementation/oversight experience preferred.
Knowledge, Skills and Abilities:
Excellent interpersonal skills, ability to develop important relationships with key stakeholders; a solutions-oriented collaborator.
Strong knowledge of relevant regulations and related obligations.
Good conflict management and negotiation skills.
Excellent organizational, communication and leadership skills.
Ability to work independently, and analyze complex issues to develop relevant and realistic plans, programs and recommendations.
Strong written, verbal, and presentation skills.
Willingness to embrace and champion Company core values.
Ability to travel on occasion when necessary.
The salary range for this position is $200,000 to $225,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Auto-ApplyManager, Commercial Analytics
Mirum Pharmaceuticals Inc. job in Foster City, CA
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
We are seeking a highly motivated Manager of Commercial Analytics to join our growing company and portfolio of products. The Manager will be responsible for providing strategic insights and analysis to support decision-making across our rare disease portfolio, specializing on the patient journey and reimbursement hub and pharmacy operations metrics. This role may also involve obtaining and analyzing secondary market data, monitoring commercial performance, identifying key drivers of success, and conducting ad hoc analysis to drive business growth. Candidates with an appropriate level of experience may be considered for a more advanced position.
JOB FUNCTIONS/RESPONSIBILITIES (examples)
* Design key performance metrics associated with the patient journey, including patient support success metrics, insurance approval metrics, and pharmacy performance metrics
* Liaise with Patient Services, Sales, Information Technology, and outside vendors associated with the company's Salesforce and other CRM systems
* Monitor and report on the patient journey and other commercial performance metrics on a regular basis (daily, weekly, monthly, quarterly) and identify any trends that require action.
* Work together with the Commercial Analytics team to present a comprehensive view of commercial performance across the company's product portfolio and books of business.
* Collaborate with cross-functional teams to understand commercial reporting needs
* Design and build commercial reporting dashboards for multiple functional audiences at the company, ensuring that our commercial team has the information they need to monitor performance vs goals
* Conduct ad hoc analytics to support key business initiatives, such as product launches, market expansions, and internal business reviews
* Analyze secondary market data to identify potential market size, key prescribers, patient demographics, and competitive landscape in multiple disease indications
* Present findings in a very clear and concise manner to internal stakeholders and senior leadership
QUALIFICATIONS
* Bachelor's degree in a Life Sciences discipline strongly preferred, though degrees in Business, Economics, or related fields will be considered
* MBA or other Master's Degree is a plus
* Minimum of 5 years of experience in the bio-pharmaceutical industry in commercial analytics, and experience in rare disease fields strongly preferred
* Exceptional Analytics skills, with the ability to deliver exactly the right information in way that is easily interpreted and understood.
* Experience with Komodo claims data or other claims data vendors
* Experience with data reporting platforms such as Power BI or Tableau
Knowledge, Skills and Abilities:
* Ability to work with and understand multiple constituencies at the company, including Executive Leadership, Sales Leadership, Sales professionals, Marketing, Medical, and Finance.
* Expert level proficiency in Microsoft Excel and Power Point
* Excellent communication and listening skills - ensure you understand what the customer really wants
* Very strong presentation skills required. You will need to deliver the results of your research appropriately to the audience in question, with the ability to anticipate (and answer) questions during your presentations.
* Ability to thrive in a fast-paced, dynamic environment. The job will be different day to day, and the successful candidate will thrive on change and the ability to respond to unanticipated projects.
The salary range for this position is $140,000 to $150,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Senior Manager, SEC Reporting & Technical Accounting
Mirum Pharmaceuticals Inc. job in Foster City, CA
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSTION SUMMARY
As Senior Manager, SEC Financial Reporting and Technical Accounting, you will be an integral part of the preparation of financial statements in compliance with US GAAP and SEC guidelines, serve as a technical accounting expert and assist in managing the SOX program for the organization. This individual interacts with various levels of management within the accounting/finance organization and third parties across financial and operational projects and initiatives. The ideal candidate is a licensed CPA with extensive biotechnology and/or pharmaceutical experience. This position reports directly to the Executive Director, SEC Reporting & Technical Accounting.
JOB FUNCTIONS/RESPONSIBILITIES
* Assist in the preparation of the quarterly and annual SEC filing on Forms 10-K and 10Q.
* Compile financial statements and footnote disclosures, as well as assist in analysis for management disclosures and other SEC disclosures.
* Ensure financial statements are prepared in accordance with US GAAP and SEC regulations, including newly issued accounting pronouncements.
* Perform technical accounting research as needed on significant or unusual transactions.
* Assist with ASC 606 revenue recognition matters for the company.
* Recommend, implement, maintain and communicate accounting policies and procedures to ensure integrity and consistency of application throughout the organization.
* Responsible for stock-based compensation accounting.
* Assist with the Company's 404 SOX compliance program including evaluating the adequacy of controls at existing and proposed new service organizations based on reporting provided by the service organizations.
* Work with Company's external SOX partners to ensure timely completion of management testing of controls.
* Assist with preparation of the annual proxy statement and other ad hoc filings.
* Prepare supporting schedules for audit committee presentations.
* Other ad hoc projects as needed.
QUALIFICATIONS
Education/Experience:
* Strong US GAAP and compliance experience .
* Minimum 5 years of progressive accounting experience including 2-3 years in a public company, at a minimum.
* CPA and Big Four experience auditing biotech companies is strongly preferred.
* Workiva experience preferred
* SEC reporting, technical accounting experience, plus operations in a SOX 404(b) environment preferred.
* Candidate performs with strong sense of urgency and works effectively under deadlines.
* Attention to detail and ability to multi-task.
* Strong written and verbal communication skills.
Education:
* Bachelor or master's degree in accounting
* CPA required
Knowledge, Skills and Abilities:
* Strong work ethic.
* Strong analytical skill.
* Excellent written and verbal communication skills.
* Self-starter with ability to prioritize workload.
* Candidate performs with strong sense of urgency and works effectively under deadlines.
* Attention to detail and ability to multi-task.
The salary range for this position is $170,000 to $190,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Senior Manager, Clinical Pharmacology and Non-Clinical Sciences
Mirum Pharmaceuticals Inc. job in Foster City, CA
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
The Senior Manager 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.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Patient Navigator
Mirum Pharmaceuticals Inc. job in Foster City, CA
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
Position Summary
Are you someone who has the proven ability to thrive in a dynamic, evolving environment and contribute to building new capabilities in healthcare. We're seeking an empathetic, detail-driven Patient Navigator to join our growing rare disease team. In this pivotal role, you'll serve as the primary liaison for patients, caregivers, and healthcare providers, ensuring a seamless experience from prescription to ongoing therapy. You will provide inbound and outbound phone support and serve as the primary contact for patients, caregivers, and providers. You will facilitate a collaborative process that gauges, coordinates, and monitors patient need and appropriately facilitates a patient's journey utilizing services offered through the Patient Support Program on behalf of Mirum and coordination with our specialty pharmacy partner. You'll work closely with the specialty pharmacy, reimbursement specialists, and internal partners to make sure patients receive their medications on time, every time. The outcome of your efforts will be to provide unparalleled customer service to patients, caregivers and providers.
If you have a nursing or case management background, you can thrive in a fast-paced biotech environment and are passionate about helping patients with rare diseases navigate complex access barriers-this is the opportunity for you.
Key Responsibilities
* Serve as the main point of contact for patients and caregivers, providing non-clinical guidance and emotional support throughout their treatment journey demonstrating a thorough understanding of the disease state and Mirum product profiles.
* Provide patients and HCPs a clear understanding of eligibility requirements, program enrollment, reimbursement process, affordability support, and general access for Mirum prescribed therapies.
* Deliver unparalleled customer service while serving as a brand advocate and program representative; understands the importance of achieving quality outcomes and commit to the appropriate use of resources
* Coordinate care between prescribers, specialty pharmacies, and insurance providers to ensure timely drug access and refills.
* Monitor patient cases to identify potential delays or issues (e.g., prior authorizations, benefit revalidations, prescription renewals) and proactively resolve them.
* Educate patients and families about program resources, refill schedules, and financial assistance options.
* Elevate the patient experience by partnering with Mirum's market access, reimbursement, and specialty pharmacy teams to resolve coverage and dispensing challenges.
* Support patient onboarding, therapy continuation, and adherence initiatives in alignment with program KPIs.
* Serve as a resource for patients and healthcare professionals to verify insurance coverage, reimbursement process, and general access for complex pharmaceuticals and ability to understand and explain benefits offered by all payer types including private/commercial and government (i.e., Medicare, Medicaid, VA and DOD)
* Patient Navigators will be regionally aligned and will serve as an expert on reimbursement, co-pay, foundation assistance, patient assistance program (PAP) issues, and other forms of available support and will be responsible for handling patient and healthcare provider interactions related to these topics in collaboration with the Regional Access Leads and Regional Account Managers.
* Responsible for communicating insurance benefit investigations, prior authorization and appeal requirements, and triage cases according to program standard operating procedures
* Serve as direct point of contact to health care providers for ongoing support and relationship development by acquiring and delivering detailed information regarding a program and/or a patient
* Evaluate program enrollment forms for data integrity and missing information
* Follow program guidelines and escalate complex cases according to program policy, SOPs, Call Guides, and other program materials.
* Working in a case management system, documenting status/background in case notes, communicating patient benefits, assisting in the PA/Appeals process and like responsibilities
* Act as an assigned liaison to customer contacts (e.g., regional contact for sales representatives), Market Access colleagues, other internal stakeholders and healthcare providers
* Works with the Program Supervisor, on a day-to-day basis to maintain open lines of communication and share awareness regarding patient status, prescriber feedback/satisfaction and program effectiveness
* Maintains a high level of ethical conduct regarding confidentiality and privacy.
* Help maintain team morale by consistently demonstrating positive attitude.
* Maintain accurate, compliant documentation within CRM and case management systems.
* Conducts miscellaneous tasks or projects as assigned identify and report pharmacovigilance information as required, i.e., Adverse Events, and Product Quality Complaints
Qualifications
* BA/BS Highly Desired.
* Registered Nurse (RN), Licensed Practical Nurse (LPN/LVN) Social Worker (BSW), or Case Manager (CCM) preferred.
* Minimum 5+ years of experience in patient navigation, specialty pharmacy, case management, or patient access preferably in biotech, rare disease, oncology or cell/gene therapy.
* Strong understanding and experience in working through benefits verification, prior authorization, and reimbursement processes.
* Exceptional communication, organization, and problem-solving skills that have been demonstrated in producing improved patient experiences and outcomes.
* Proven ability to work independently in a high-volume, fast paced and patient-focused environment.
* Empathetic and patient-centered mindset with a commitment to improving rare disease care.
* Ability to multitask and balance multiple priorities at once.
* Demonstrated ability to deliver meaningful & concise conversations with integrity and empathy directly to patients and health care providers
* Experience using CRM or case tracking systems (Salesforce Health Cloud preferred)
* In-depth understanding of health insurance benefits, relevant state and federal laws and insurance regulations.
* Excellent written and oral communication, and problem-solving skills, including the ability to connect with patients, caregivers, and providers.
* Experience and demonstrated success working in a complex matrix to accomplish goals with a patient centric approach.
* Strong people skills that demonstrate flexibility, persistence, creativity, empathy, and trust.
* Robust computer literacy skills including data entry and MS Office-based software programs.
* Possesses strong business acumen and strategic thinking skills.
* Ability to identify and handle sensitive issues, working independently and collaboratively within teams.
* Ability to travel required, ~10%, possibly weekends.
* This position is based in Foster City, CA or Charlotte, NC. Applicants must reside in a location which would allow them to comply with Mirum's hybrid work policy.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Senior Associate, Medical Safety Operations
Mirum Pharmaceuticals job in Foster City, CA
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
The Senior Associate, Drug Safety in Medical Safety Operations will support vendor oversight activities with respect to the individual case safety report (ICSR) management process at Mirum.
JOB FUNCTIONS/RESPONSIBILITIES
Perform routine retrospective quality review of the safety data collected to ensure completeness and accuracy. Collaborate with the pharmacovigilance (PV) vendor to address case corrections and trends.
Provide case processing guidance to the PV vendor in alignment with existing Mirum standards.
Review case metrics to ensure cases processed by the PV vendor are processed and exchanged within the agreed upon timelines.
Oversee and support reconciliation of safety data from various sources.
Oversee submission of expedited safety reports by the PV vendor and clinical contract research organizations; escalate and document late regulatory authority submissions.
Generate listing from Safety Database (Argus) or OBIEE as needed.
Responsible for interdepartmental collaboration, such as, but not limited to Quality Assurance, Clinical Operations, Regulatory Affairs on obtaining additional information as needed by PV vendor.
Manage and/or support system access (e.g. EDC, Argus etc.) along with periodic review of user access.
QUALIFICATIONS
Education/Experience:
Minimum of 3 years direct pharmaceutical industry experience dealing with global clinical study individual case safety report processing and reporting preferred; post-approval safety experience highly desired.
Detailed knowledge of relevant US, EU, and ICH guidelines, initiatives and regulations governing both clinical studies and post-approval safety.
Knowledge, Skills and Abilities:
Bachelor's degree in life sciences.
Safety database experience is required.
Proficient in MS Word, Excel, PowerPoint, Outlook, and other applicable business software tools.
Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Auto-ApplySenior Manager, Corporate Development
Mirum Pharmaceuticals job in Foster City, CA
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSTION SUMMARY
The Senior Manager/Associate Director Corporate Development will report to the Executive Director of Corporate Development. This position requires an ability to quickly grasp and articulate scientific, clinical, commercial, and strategic topics relevant to the evaluation of potential partnering opportunities in the backdrop of Mirum's strategic priorities. The individual chosen for this role will:
PRIMARY RESPONSIBILITIES
Proactively source potential peri-clinical and clinical stage assets using a variety of databases, secondary research sources, by attending partnering conferences, networking, and staying abreast of industry trends and advancements.
Identify, evaluate, and prioritize new business opportunities, including partnerships, licensing, collaborations, and M&A
Coordinate team diligence efforts including scientific and clinical reviews and commercial assessments
Support all aspects of transaction execution, including due diligence, financial modeling, valuation analysis, contract negotiations, and post-deal integration planning.
Conduct interviews with key opinion leaders as needed to gain insights into new disease areas and new therapies in development.
Prepare and deliver presentations, deal proposals, and updates to senior leadership and board-level stakeholders.
Participate in strategic projects to support corporate development initiatives.
Manage outside consultants as needed to support new opportunity assessments.
work with the R&D team to assess the technical feasibility and fit of potential of clinical stage assets with existing product pipeline and company capabilities.
QUALIFICATIONS
Education/Experience:
A PhD, MD, MD/PhD, or Pharm D. with a keen scientific acumen and strong interest and/or experience in biotech/pharma.
Management consulting background is desirable.
Knowledge, Skills and Abilities:
Genuine interest in healthcare and patient focused work
Strong organizational skills, with the ability to prioritize critical workstreams while balancing many projects.
Strong project management skills with the ability to manage cross-functional teams in evaluating partnering opportunities.
Highly collaborative with the ability to thrive in a fast-paced, dynamic, and entrepreneurial environment
Strong communication skills with the ability to effectively communicate scientific and clinical findings in written and oral formats.
Ability to produce high quality outputs of due diligence findings to enable decision-making.
Ability to present individual and team recommendations clearly and concisely and foster cross-functional consensus-building.
Excellent analytical skills, with the ability to synthesize complex scientific and business information.
The salary range for this position is $190,000 to $205,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Auto-ApplySenior Manager, SEC Reporting & Technical Accounting
Mirum Pharmaceuticals job in Foster City, CA
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSTION SUMMARY
As Senior Manager, SEC Financial Reporting and Technical Accounting, you will be an integral part of the preparation of financial statements in compliance with US GAAP and SEC guidelines, serve as a technical accounting expert and assist in managing the SOX program for the organization. This individual interacts with various levels of management within the accounting/finance organization and third parties across financial and operational projects and initiatives. The ideal candidate is a licensed CPA with extensive biotechnology and/or pharmaceutical experience. This position reports directly to the Executive Director, SEC Reporting & Technical Accounting.
JOB FUNCTIONS/RESPONSIBILITIES
Assist in the preparation of the quarterly and annual SEC filing on Forms 10-K and 10Q.
Compile financial statements and footnote disclosures, as well as assist in analysis for management disclosures and other SEC disclosures.
Ensure financial statements are prepared in accordance with US GAAP and SEC regulations, including newly issued accounting pronouncements.
Perform technical accounting research as needed on significant or unusual transactions.
Assist with ASC 606 revenue recognition matters for the company.
Recommend, implement, maintain and communicate accounting policies and procedures to ensure integrity and consistency of application throughout the organization.
Responsible for stock-based compensation accounting.
Assist with the Company's 404 SOX compliance program including evaluating the adequacy of controls at existing and proposed new service organizations based on reporting provided by the service organizations.
Work with Company's external SOX partners to ensure timely completion of management testing of controls.
Assist with preparation of the annual proxy statement and other ad hoc filings.
Prepare supporting schedules for audit committee presentations.
Other ad hoc projects as needed.
QUALIFICATIONS
Education/Experience:
Strong US GAAP and compliance experience .
Minimum 5 years of progressive accounting experience including 2-3 years in a public company, at a minimum.
CPA and Big Four experience auditing biotech companies is strongly preferred.
Workiva experience preferred
SEC reporting, technical accounting experience, plus operations in a SOX 404(b) environment preferred.
Candidate performs with strong sense of urgency and works effectively under deadlines.
Attention to detail and ability to multi-task.
Strong written and verbal communication skills.
Education:
Bachelor or master's degree in accounting
CPA required
Knowledge, Skills and Abilities:
Strong work ethic.
Strong analytical skill.
Excellent written and verbal communication skills.
Self-starter with ability to prioritize workload.
Candidate performs with strong sense of urgency and works effectively under deadlines.
Attention to detail and ability to multi-task.
The salary range for this position is $170,000 to $190,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Auto-ApplySenior Director, Intellectual Property Attorney
Mirum Pharmaceuticals job in Foster City, CA
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
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.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Auto-ApplySenior Product Marketing Manager
Mirum Pharmaceuticals job in Foster City, CA
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
The Senior Product Marketing Manager, Bile Acid Portfolio, will play a critical support role to the Marketing Director in the strategic and tactical execution of marketing initiatives for CTEXLIâ„¢ and CHOLBAM . This individual will help plan, coordinate, and implement key brand activities across digital, field, patient, and healthcare provider channels.
This role is ideal for a motivated, resourceful, and digitally-savvy professional who is eager to learn, take ownership of meaningful projects, and grow within a high-performing, mission-driven commercial team.
JOB FUNCTIONS/RESPONSIBILITIES
Brand & Marketing Support
Partner with the Marketing Director to execute the annual brand plans for CTEXLI and CHOLBAM.
Assist in developing marketing materials (HCP, patient/caregiver, digital) in alignment with strategic objectives and compliance standards.
Support execution of omnichannel marketing initiatives, including HCP and patient campaigns, digital content, CRM/email marketing, and social media.
Coordinate review and approval (MLR) processes, ensuring materials are accurate, timely, and compliant.
Support tactical execution of field force tools and branded and unbranded education initiatives.
Manage creative and digital agency partners, ensuring deliverables are high-quality, compliant, and on-time.
Support ongoing field team enablement through tools, resources, and internal communications.
Maintain awareness of emerging digital tools and rare disease engagement innovations.
Help maintain brand budgets and timelines.
Coordinate logistics for congresses, speaker programs, and HCP & patient events.
Prepare summaries, presentations, and reports for leadership and brand review meetings.
Work closely with cross-functional partners (Medical Affairs, Market Access, Patient Services, Commercial Operations, and Field Teams) to ensure alignment and seamless execution.
Qualifications
Education & Experience
Bachelor's degree in business, marketing, life sciences, or related field required
5+ years of experience in pharmaceutical marketing, product management, or commercial operations, ideally in rare disease.
Knowledge, Skills and Abilities:
Strong organizational, project management, and communication skills.
High attention to detail with ability to manage multiple priorities and deadlines.
Digital fluency - comfortable with CRM systems, analytics platforms, and digital campaign tools.
Analytical mindset - able to synthesize data and insights to inform decisions.
Collaborative, flexible, and proactive - thrives in a dynamic, fast-paced environment.
Passionate about helping patients with rare diseases and driven by purpose.
Resourceful and eager to learn - a self-starter who takes ownership and seeks opportunities for growth.
Graphic design and experience with Adobe Creative Cloud (InDesign, Photoshop, etc.) a plus.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Auto-ApplySenior Clinical Project Manager
Mirum Pharmaceuticals job in Foster City, CA
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
The role will be responsible for 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. Manages selected CROs and leads cross-functional project teams (clinical monitoring, data management, biostatistics, medical writing, medical affairs, regulatory affairs, and clinical QA) to ensure the project 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.
Establish communication plans for information distribution to team members.
Manage project/program meetings.
Conduct project/program reviews at significant milestones or gates to evaluate successes as compared to baseline estimates.
Integrate understanding of constraints across and within projects and recommend alternatives.
Identify and track key study metrics in order 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 regulatory submission preparations.
Author/Oversee the development of plans and execution of those plans related to project management, site monitoring, safety management, data management and biostatistics.
Identify, evaluate, and select 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.
Perform periodic visits to sites and/or CROs to assess the progress of studies/protocol compliance. Develops/reviews and approves study plans.
Develop contracts for and perform ongoing management of vendors to ensure deliverables and performance adhere to contract.
Oversee the identification, selection, and proper initiation of sites.
Develop patient recruitment strategies to ensure enrollment goals are achieved
Oversee development of CRFs, and clinical databases, support development of safety databases, and shell Tables, Figures and Listings.
Plan, coordinate, and conduct investigator meetings.
Contribute to planning, coordination and conduct of Data Monitoring Committee (DMC) meetings.
With Medical and Safety, assess trends in data including adverse events, protocol violations, etc.
Oversee timely database freeze and database lock. Participate in data review meetings.
Oversee maintenance of the Trial Master File for each project and oversee the archival process.
Ensure adherence to SOPs, GCP and 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 experience as a global clinical project manager.
Experience in rare disease preferred.
Experience working in a fully outsourced model.
Experience in small, fast-paced biotech is a plus.
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 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, as well as CROs
Ability to work with minimal supervision, take initiative and complete tasks to deadlines, and resolve/escalate 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 growing 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 $190,000 to $205,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Auto-ApplySenior Manager, Clinical Pharmacology and Non-Clinical Sciences
Mirum Pharmaceuticals job in Foster City, CA
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
The Senior Manager 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.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Auto-ApplySenior Director, Program Management
Mirum Pharmaceuticals job in Foster City, CA
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
We are seeking a strategic and operationally-savvy leader to oversee and drive the program management function at Mirum, building best-in-class program management practices and strategic approaches to drive results. This leader will have responsibility for establishing program-related processes, systems, and templates to enable portfolio-level oversight and decision-making. They will lead and mentor a team of program management professionals and foster strong partnerships across internal teams to ensure program success and maximize portfolio value.
JOB FUNCTIONS/RESPONSIBILITIES
Lead a high-performing Project Management Office that supports strategic planning and execution across all development programs.
Establish and manage program governance to enable prioritization of resources and activities including the facilitation of annual operating plan process in conjunction with FP&A.
Develop, implement and continuously refine PMO processes, frameworks and tools (e.g., timelines, stage-gates, communication plans, resource planning, budgeting, decision-making, etc.).
Serve as a strategic partner and communicator with senior leadership: provide program status, decision-support, trade-offs, and portfolio linkage.
Facilitate decision-making processes, including risk mitigation strategies and scenario planning.
In partnership with program managers, identify key hurdles across programs.
Identify, assess and proactively mitigate portfolio-level program risks and dependencies; escalate issues appropriately.
Maintain continuous communication with Program Leads to ensure timely support and proactive involvement in program dynamics and team performance.
Drive cross-functional collaboration: align stakeholders (clinical, regulatory, CMC, finance, commercial) around program strategy and deliverables.
Mentor and develop program managers, fostering a culture of accountability, innovation, and continuous improvement.
Coach and mentor PT members on their roles, team interactions, program deliverables & interdependencies, action plans, presentations (executive style) to senior management
Actively resolve issues and elevate concerns with a sense of urgency to promote a culture of rapid improvement and responsiveness.
Serve as the Program Manager for one of Mirum's programs or during corporate development evaluation of potential new assets, as needed
QUALIFICATIONS
Education/Experience:
Bachelor's degree in life sciences, engineering or related field required; advanced degree (MS, PhD, MBA) strongly preferred.
10+ years of experience in the biotech or pharmaceutical industry, with substantive exposure to drug (or biologic/therapy) development.
Demonstrated portfolio and program management experience with cross-functional and global teams, including milestone budget/resourcing management.
Previous experience building a PMO is a plus.
Knowledge, Skills and Abilities:
Deep understanding of the therapeutic development lifecycle, including non-clinical, clinical, CMC/manufacturing, regulatory and commercial interface.
Excellent leadership, communication and interpersonal skills: ability to influence without direct authority, build relationships across functions and navigate matrix environments.
Strong analytical and problem-solving capabilities; comfortable with ambiguity and dynamic change.
Familiarity with program management tools and frameworks (e.g., MS Project, Smartsheet, stage-gate process).
The salary range for this position is $290,000 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.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Auto-ApplySenior Manager, Corporate Development
Mirum Pharmaceuticals Inc. job in Foster City, CA
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSTION SUMMARY
The Senior Manager/Associate Director Corporate Development will report to the Executive Director of Corporate Development. This position requires an ability to quickly grasp and articulate scientific, clinical, commercial, and strategic topics relevant to the evaluation of potential partnering opportunities in the backdrop of Mirum's strategic priorities. The individual chosen for this role will:
PRIMARY RESPONSIBILITIES
* Proactively source potential peri-clinical and clinical stage assets using a variety of databases, secondary research sources, by attending partnering conferences, networking, and staying abreast of industry trends and advancements.
* Identify, evaluate, and prioritize new business opportunities, including partnerships, licensing, collaborations, and M&A
* Coordinate team diligence efforts including scientific and clinical reviews and commercial assessments
* Support all aspects of transaction execution, including due diligence, financial modeling, valuation analysis, contract negotiations, and post-deal integration planning.
* Conduct interviews with key opinion leaders as needed to gain insights into new disease areas and new therapies in development.
* Prepare and deliver presentations, deal proposals, and updates to senior leadership and board-level stakeholders.
* Participate in strategic projects to support corporate development initiatives.
* Manage outside consultants as needed to support new opportunity assessments.
* work with the R&D team to assess the technical feasibility and fit of potential of clinical stage assets with existing product pipeline and company capabilities.
QUALIFICATIONS
Education/Experience:
* A PhD, MD, MD/PhD, or Pharm D. with a keen scientific acumen and strong interest and/or experience in biotech/pharma.
* Management consulting background is desirable.
Knowledge, Skills and Abilities:
* Genuine interest in healthcare and patient focused work
* Strong organizational skills, with the ability to prioritize critical workstreams while balancing many projects.
* Strong project management skills with the ability to manage cross-functional teams in evaluating partnering opportunities.
* Highly collaborative with the ability to thrive in a fast-paced, dynamic, and entrepreneurial environment
* Strong communication skills with the ability to effectively communicate scientific and clinical findings in written and oral formats.
* Ability to produce high quality outputs of due diligence findings to enable decision-making.
* Ability to present individual and team recommendations clearly and concisely and foster cross-functional consensus-building.
* Excellent analytical skills, with the ability to synthesize complex scientific and business information.
The salary range for this position is $190,000 to $205,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.
#LI-HYBRID
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.