Foster City

POSITION SUMMARY

Senior Manager of Translational Pharmacology at Mirum, responsible for the General Pharmacology, Animal Efficacy, PK/PD, ADME, Bioanalytical, Translational Biomarker, and related studies required for further development and approval of Mirum rare disease assets.  As a key member of the small Clinical Pharmacology & Nonclinical Sciences group, will represent these multiple functions within broad multidisciplinary drug development teams to define the strategy and tactics, and oversee execution and analysis of required studies through CROs to achieve team goals.

JOB FUNCTIONS/RESPONSIBILITIES

• Leads the design, and responsible for the execution of nonclinical plans (bioanalytical, animal efficacy, clinical biomarkers) for all Mirum assets
• Leads the authoring and completion of the relevant sections of IND, NDA, MAA, other regulatory documents and works closely with Regulatory to support nonclinical and clinical document submission
• Outsources nonclinical and bioanalytical studies, reviews resulting pharmacology and biomarker data, and reports to check for completeness and accuracy and communicate to teams
• Provide input on clinical trials protocols (informed consent, exclusion criteria, blood sampling, etc.) to enable measurement of relevant biomarkers
• Provides CROs with technical oversight as needed and ensures that assay development, validations and data transfers occur at CROs and in-house to meet project goals
• Represent pharmacology and translational arena with regulatory agencies (responses to queries, preparation of pre-meeting documents, attend teleconferences and meetings with Health Authorities, as needed)
• Play a key role in due diligence efforts for potential drug in-licensing or partner opportunities, including review of existing data and development of pharmacology and translational strategy

QUALIFICATIONS

• Previous experience with immunology of the liver and/or neurology preferred, especially in the context of rare disease

Education/Experience: 

• BS in Biological Sciences and minimum of 7 years of relevant experience, or an advanced degree (PhD, PharmD) with fewer years of experience

Knowledge, Skills and Abilities:

• Thorough understanding of the nonclinical and clinical data requirements, including regulatory guidance, to support drug development
• Experience authoring and supporting regulatory filings (INDs, NDAs, MAA, DSURs, IBs, etc)
• Deep knowledge of pharmacology and biomarker study design and interpretation, pharmacodynamics, and pharmacokinetics modeling
• Extensive experience coordinating studies through CROs
• Strong knowledge of GLP/GCP compliance in supporting the nonclinical and clinical studies
• Solid Project Management skills, ability to create and manage project plans, budgets, and schedules
• Recognized for being well organized and self-directed with strong interpersonal skills and with an ability to communicate to people at all levels of the organization.

The salary range for this position is $190,000 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.

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