Vice President, Nonclinical and Clinical Pharmacology

Mirum Pharmaceuticals•Foster City, CA

1d•$300,000 - $330,000•Hybrid

About The Position

MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. POSITION SUMMARY Lead for NonClinical and Clinical Pharmacology Functions at Mirum.

Requirements

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

Nice To Haves

Board certification in toxicology (DABT) preferred

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