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Salary: USD 230,000 - 250,000 / annual
Mirum Pharmaceuticals, a biopharmaceutical company focused on rare disease treatments, seeks a Director of Clinical Pharmacology to lead all aspects of clinical pharmacology in the development and regulatory approval of rare disease assets. This is a key role within the Development Sciences group, where you will serve as the clinical pharmacology subject matter expert on multidisciplinary drug development teams.
You will be responsible for defining clinical pharmacology strategy and overseeing execution of required studies and analyses through contract research organizations (CROs) to achieve program milestones. Key responsibilities include:
• Serve as clinical pharmacology lead on project and study teams, providing expert guidance on clinical development programs
• Lead the design and execution of clinical pharmacology strategy, from study design and planning through data analysis, interpretation, and reporting to support critical decisions such as dose selection
• Manage collaborations with CROs and consultants, providing technical oversight and ensuring quality deliverables
• Author clinical pharmacology sections of regulatory documents including clinical study protocols, clinical study reports, Investigator's Brochures, IND/NDA/MAA submissions, and regulatory responses
• Contribute to due diligence efforts for potential drug in-licensing or partnership opportunities, including data review and clinical pharmacology strategy development
You will work with various therapeutic modalities including small molecules, antibodies, and antibody-drug conjugates (ADCs). Experience with liver, neurology, or rare disease indications is valued.
REQUIREMENTS:
• Education: BS in Biological Sciences with 12–15+ years of clinical pharmacology experience, OR advanced degree (PhD, PharmD) with 10+ years of clinical pharmacology experience
• Proficiency in design, execution, and interpretation of clinical pharmacology studies, including PK and PD assessments
• Thorough understanding of clinical pharmacology requirements and regulatory guidance for drug development
• Proven track record as both individual contributor and collaborative team member
• Experience authoring and supporting regulatory filings (IND, NDA, MAA)
• Experience coordinating studies through CROs
• Solid knowledge of GCP compliance in clinical studies
• Proficiency in regulatory interactions (written and verbal)
• Knowledge of PopPK, PBPK, exposure-response, or PK/PD modeling
• Strong project management skills including budget and schedule management
• Excellent written and verbal communication and interpersonal skills
• Self-directed, well-organized, flexible, detail-oriented, and able to manage multiple priorities
