Mirum Pharmaceuticals, Inc. · 1 day ago
Vice President, Nonclinical and Clinical Pharmacology
Foster City
Full-time
Hybrid
Director/Executive
$300K/yr - $330K/yr
15+ years expMirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. They are seeking a Vice President to lead the Nonclinical and Clinical Pharmacology Functions, overseeing the development plans, managing teams, and ensuring compliance with regulatory requirements.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Lead the design and execution of a nonclinical and clinical pharmacology development plan for all Mirum assets
Develop resource plan via employees and vendors to enable nonclinical and clinical pharmacology development of Mirum assets
Manage nonclinical team members and coordinate across functions to achieve nonclinical and clinical pharmacology goals
Continually review and monitor guidance, regulations, and publications in nonclinical and clinical pharmacology development and relevant therapeutic areas
Assess nonclinical safety findings for potential expedited safety reporting
Provide input on clinical safety programs (informed consent, exclusion criteria, pregnancy, etc.) and clinical pharmacology programs (ADME, DDIs, PK/PD, BE, etc)
Identify and work with expert consultants as needed to fill project needs
Ensure the completion of the relevant sections of IND, NDA, MAA, other regulatory documents, and ensure robust responses for information requests
Represent nonclinical and clinical pharmacology with regulatory agencies (responses to queries, preparation of pre-meeting documents, attend teleconferences and meetings with Health Authorities, as needed)
Lead due diligence efforts for potential drug in-licensing or partner opportunities, including assessment and review of existing data and development of nonclinical strategy
Provide expertise and execute non-clinical efficacy research for translation into clinical programs, including resourcing appropriate animal models and interpretation of results, in partnership with senior management team
Qualification
Required
Advanced science degree (e.g. PhD, PharmD)
10+ years leadership experience
15+ years drug development experience
Ability to understand and effectively communicate scientific information
Thorough understanding of the nonclinical and clinical pharmacology requirements, including regulatory guidance, to support drug development in US and EU
Deep knowledge of toxicology study design and interpretation, pharmacodynamics and pharmacokinetics modeling
Extensive experience coordinating studies through CROs
Extensive experience authoring and supporting regulatory filings (INDs, NDAs, MAA, DSURs, IBs, etc)
Preferred
Board certification in toxicology (DABT)
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
2026-01-03
2025-12-30
2025-12-19
Company data provided by crunchbase