Senior Director, Clinical Pharmacology: Phase 1 Leader

Mirador Therapeutics, Inc.; San Diego (CA); On-site; USD 250,000 - 300,000; Full time

Job summary

Mirador Therapeutics, Inc. is seeking a Senior Director of Clinical Pharmacology to lead Phase 1 studies from protocol concept through study report, while managing budgets, timelines, and vendor relationships.

The role encompasses PK/PD modeling, dose selection decisions, and regulatory content development for IND modules, DSURs, and Health Authority responses. Collaboration with Clinical Operations, Medical Writing, Regulatory Affairs, and biomarker teams is essential for early-development

Qualifications

• PhD, PharmD or equivalent in clinical pharmacology or related field.
• 10+ years biotech/pharmaceutical industry experience in early clinical development.
• Experience as Study Director on first-in-human studies and IND maintenance.
• Strong PK/PD knowledge and hands-on modeling experience to inform dose selection.
• Experience with immunology or inflammation programs is a plus.

Responsibilities

• Serve as Study Director for multiple Phase 1 studies and oversee protocols from concept to clinical study report.
• Author protocol amendments with Medical Writing and lead cross-functional reviews.
• Lead day-to-day interfaces with Phase 1 units, CROs, and study teams to maintain schedules.
• Coordinate safety reviews, PK/PD data interpretation, and biomarker sampling schemes.
• Manage vendors, data flow, and regulatory deliverables for IND maintenance.
• Prepare regulatory briefing content and support health authority interactions.
• Contribute to late-stage pharmacology needs and due diligence for external assets.

Skills

Clinical pharmacology

Study leadership

Pharmacometric modeling

Regulatory writing

Education

PhD/PharmD

Tools

Phoenix WinNonlin

NONMEM

R

Job description

Mirador Therapeutics, Inc. is seeking a Senior Director of Clinical Pharmacology to lead Phase 1 studies from protocol concept through study report, while managing budgets, timelines, and vendor relationships.

The role encompasses PK/PD modeling, dose selection decisions, and regulatory content development for IND modules, DSURs, and Health Authority responses. Collaboration with Clinical Operations, Medical Writing, Regulatory Affairs, and biomarker teams is essential for early-development