Vice President, Nonclinical and Clinical Pharmacology

POSITION SUMMARY 

Lead for NonClinical and Clinical Pharmacology Functions at Mirum.

JOB FUNCTIONS/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

QUALIFICATIONS 

Education/Experience:

• Advanced science degree (e.g. PhD, PharmD)
• Board certification in toxicology (DABT) preferred
• 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 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)

The salary range for this position is $300,000 to $330,000 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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