Associate Director, Non-Clinical

POSITION SUMMARY

Associate Director of Non-Clinical (clinical pharmacology) at Mirum, responsible for the PK/PD, ADME, Bioanalytical, Biomarker, and Related Clinical Pharmacology studies required for further development and approval of Mirum rare disease assets. As a key member of the small translational sciences group, will represent these multiple functions within broad multidisciplinary drug development teams to define the strategy and tactics, and oversee execution of required studies through CROs to achieve team goals.

JOB FUNCTIONS/RESPONSIBILITIES

• Leads the design, and responsible for the execution of nonclinical plans (bioanalytical, clinical bioanalytical) 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 PK and bioanalytical data, and reports to check for completeness and accuracy and communicate to teams.
• Provide input on clinical safety programs (informed consent, exclusion criteria, pregnancy, etc.) and clinpharm programs (ADME, DDIs, PK/PD, BE, etc.).
• 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 nonclinical and clinpharm 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 nonclinical strategy.

QUALIFICATIONS       

Education/Experience: 

• BS in Biological Sciences and minimum of 10 years of relevant experience, or an advanced degree (PhD, PharmD) with fewer years of experience.
• Previous experience with assets for neurology indications (brain active molecules) preferred.

Knowledge, Skills and Abilities:

• Thorough understanding of the clinpharm requirements, including regulatory guidance, to support drug development.
• Experience authoring and supporting regulatory filings (INDs, NDAs, MAA, DSURs, IBs, etc.).
• Deep knowledge of clinpharm 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.

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