POSITION SUMMARY 

Executive leader responsible for Clinical Pharmacology strategy and its integration across all development programs at Mirum, with potential scope to oversee broader pharmacology functions, including nonclinical pharmacology, depending on candidate experience.

JOB FUNCTIONS/RESPONSIBILITIES

• Lead the design and execution of a clinical pharmacology development plan for all Mirum assets
• Unique opportunity to join a development and commercial stage company on a growth trajectory
• Set the clinical pharmacology strategy across the portfolio aligned with corporate and regulatory objectives
• Develop resource plans via employees and vendors to enable clinical pharmacology development of Mirum assets
• Build and lead the Clinical Pharmacology function, including talent strategy and capability development
• Lead an accomplished, high-functioning team with a focus on scaling the group for continued growth
• Lead and influence cross-functional teams to achieve clinical pharmacology goals
• Serve as a key contributor to development governance and decision-making
• Continually review and monitor guidance, regulations, and publications in clinical pharmacology development and relevant therapeutic areas
• 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 completion of relevant sections of IND, NDA, MAA, and other regulatory documents, and ensure robust responses to information requests
• Serve as a senior representative with regulatory agencies, including responses to queries, preparation of pre-meeting documents, and participation in Health Authority meetings
• Lead due diligence efforts for potential drug in-licensing or partner opportunities, including assessment and review of existing data and development of clinical pharmacology strategy
• Scope may expand to include leadership of nonclinical pharmacology activities, aligned with candidate expertise and organizational needs

QUALIFICATIONS 

Education/Experience:

• Advanced science degree (e.g. PhD, PharmD)
• 10+ years leadership experience and 15+ years drug development experience

 Knowledge, Skills and Abilities: 

• 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 pharmacodynamics and pharmacokinetics principles and modeling
• Extensive experience coordinating studies through CROs
• Extensive experience authoring and supporting regulatory filings (INDs, NDAs, MAA, DSURs, IBs, etc)

The salary range for this position is $320,000 to $350,000 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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