Senior Manager, Clinical Pharmacology and Non-Clinical Sciences jobs in United States
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Mirum Pharmaceuticals, Inc. · 1 day ago

Senior Manager, Clinical Pharmacology and Non-Clinical Sciences

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. The Senior Manager of Clinical Pharmacology will oversee clinical pharmacology aspects in the development of rare disease assets and lead collaborations with CROs to ensure successful project execution.

BiotechnologyHealth CarePharmaceuticalTherapeutics
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H1B Sponsor Likelynote

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

Qualification

Clinical pharmacology expertisePK/PD modelingRegulatory filings experienceCRO collaborationProject management skillsCommunication skillsTeam collaborationDetail-oriented

Required

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

Preferred

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

Company

Mirum Pharmaceuticals, Inc.

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Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults.

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 Company
Total Funding
$765.5M
Key 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

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Joanne Quan
Chief Medical Officer
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Company data provided by crunchbase