Director, Clinical Pharmacology

POSITION SUMMARY

The Director of Clinical Pharmacology will be responsible for all aspects of clinical pharmacology in the development and approval of Mirum rare disease assets.  As a key member of the small Clinical Pharmacology & Nonclinical Sciences group, the individual will represent these multiple functions on multidisciplinary drug development teams to define the strategy and oversee the execution of required studies/analyses through CROs to achieve team goals.

JOB FUNCTIONS/RESPONSIBILITIES

• Serves as the clinical pharmacology lead on project and study teams, providing subject matter expertise on clinical development programs
• Leads the design and is responsible for the execution of the clinical pharmacology strategy (from study design, planning, and oversight to data analysis, interpretation, and reporting) in support of key decisions/milestones (e.g., dose selection)
• Manages collaborations with CROs and consultants, providing technical oversight as needed and ensuring timely and quality deliverables to fulfill project goals
• Leads the authoring of clinical pharmacology sections of regulatory documents (clinical study protocol, CSR, Investigator’s Brochure, IND, NDA, MAA, briefing materials, response to queries)
• Plays a key role in due diligence efforts for potential drug in-licensing or partner opportunities, including review of existing data and development of clinical pharmacology strategy

QUALIFICATIONS

• Prior experience with assets in liver, neurology, or rare disease indications is a plus
• Experience with various therapeutic modalities (small molecule, antibody, ADC)

Education/Experience:

• BS in Biological Sciences with 12-15+ years or an advanced degree (PhD, PharmD) with 10+ years of experience in clinical pharmacology

Knowledge, Skills and Abilities:

• Proficiency in the design, execution, and interpretation of clinical pharmacology studies, including PK and PD assessments
• Thorough understanding of clinical pharmacology requirements, including regulatory guidance, to support drug development
• Proven track record of success as both an individual contributor and a collaborative team member
• Experience authoring and supporting regulatory filings (IND, NDA, MAA)
• Experience coordinating studies through CROs
• Solid knowledge of GCP compliance in supporting clinical studies
• Proficient in regulatory interactions both written and verbal
• Knowledge of PopPK, PBPK, exposure-response, or PK/PD modeling
• Solid project management skills: ability to create and manage project plans, budgets, and schedules
• Strong communication skills (written and verbal) and interpersonal skills with an ability to communicate to people at all levels of the organization
• Recognized for being self-directed, well-organized, flexible, and detail-oriented; able to complete multiple activities while maintaining quality

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