Mirum Pharmaceuticals, Inc. · 1 day ago
Senior Clinical Project Manager
Foster City, CA
Full-time
Hybrid
Senior Level
$190K/yr - $205K/yr
5+ years expMirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. The Senior Clinical Project Manager will be responsible for the overall management and coordination of operational activities involved in clinical trials, ensuring projects are completed on time, within budget, and with high quality.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
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)
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
Qualification
Required
Bachelor's degree or equivalent in the life sciences or related field required
At least 5 years experience as a global clinical project manager
Expert and extensive knowledge of CRO / vendor management and global protocol operations
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
Preferred
Experience in rare disease
Experience working in a fully outsourced model
Experience in small, fast-paced biotech
Company
Mirum Pharmaceuticals, Inc.
Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults.
201-500 employees
H1B Sponsorship
Mirum Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (2)
2023 (1)
2022 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$765.5MKey Investors
TCG CrossoverOberland CapitalNew Enterprise Associates
2025-12-19Post Ipo Equity· $68.5M
2025-12-08Post Ipo Equity· $200M
2023-04-12Post Ipo Equity· $275M
Leadership Team
Joanne Quan
Chief Medical Officer
Recent News
Labiotech UG
2026-01-08
2026-01-03
2025-12-30
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