Senior Director, Clinical Pharmacology

Mirador Therapeutics, Inc. is a clinical-stage precision medicine company focused on developing first-and/or best-in-class next-generation therapeutics for immunology and inflammation. The company’s Mirador
360™ precision development engine leverages the latest advances in human genetics and data science to rapidly deliver new precision medicines for patients living with immune-mediated inflammatory and fibrotic diseases. Mirador has raised over $650 million from leading life sciences investors and is based in San Diego, CA. Mirador was named Best Places to Work by Biospace and is a Great Place to Work-Certified™ Company.

The Senior Director, Clinical Pharmacology is accountable for the oversight and delivery of Mirador’s Phase 1 studies and serves as Study Director for several studies concurrently, from protocol concept through clinical study report. The position owns protocol authoring and amendments, the day-to-day sponsor interface with Phase 1 units and contract research organizations, and study-level budgets, timelines and vendor management, working in close partnership with Clinical Operations.

The role also supports the operational regulatory documents that keep our INDs current (IND modules and amendments, annual reports and DSURs, and responses to health authority information requests) and contributes to the clinical pharmacology needs of later-phase programs and in-licensing diligence, including clinical pharmacology development plans and the recommended Phase 2 dose. The position reports to the Vice President, Early Clinical Development & Pharmacology.

We are seeking a hands-on early development leader who has carried programs rather than advised on them. This role provides the scientific and operational leadership that takes each study from a well-designed protocol to a clean, interpretable dataset. The incumbent is expected to apply pharmacokinetic/pharmacodynamic and model-informed drug development principles as needed to inform study design, dose selection, and data interpretation.

The role works closely with Clinical Operations, R&D (biomarker and translational support), Medical Writing, Regulatory Affairs, Biostatistics and Data Management, and our external partners.

• Serve as Study Director for several concurrent Phase 1 studies, including first-in-human single- and multiple-ascending-dose studies and clinical pharmacology studies (e.g., relative bioavailability, formulation or device bridging, drug interaction and special population studies), with accountability for scientific integrity, quality, and timelines from protocol concept through clinical study report.
• Author, in collaboration with Medical Writing, Phase 1 protocols and protocol amendments and lead their cross-functional review and approval. Co-develop the scientific rationale for study design and dose selection with the Head of function, and own its translation into protocol text, dose-escalation and stopping rules, and PK/PD and biomarker sampling schemes.
• Act as the sponsor’s primary day-to-day interface with Phase 1 units, investigators and CROs: lead study team meetings, track start-up, enrollment, dosing and data flow, anticipate risks and drive issues to resolution to keep studies on plan.
• Partner with the study medical monitor to run safety review committee and dose-escalation meetings, ensuring integrated safety, PK and PD data are available, reviewed and documented to support each escalation decision.
• With Clinical Operations, select, contract and manage study vendors (CROs, Phase 1 units, bioanalytical, biomarker and central laboratories, and data systems); scope work orders and change orders and hold vendors accountable to quality, timeline and budget commitments.
• Own data…