Vice President, Nonclinical and Clinical Pharmacology

Role Summary

Lead for NonClinical and Clinical Pharmacology Functions at Mirum.

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

• Required: Advanced science degree (e.g. PhD, PharmD)
• Preferred: Board certification in toxicology (DABT)
• Required: 10+ years leadership experience
• Required: 15+ years drug development experience

Skills

• 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)

Education

• Advanced science degree (e.g. PhD, PharmD)