Lead Clinical Pharmacology Director, Phase 1 Studies

BioSpace; San Diego (CA); On-site; USD 250,000 - 300,000; Full time

Benefits offered by this job

Bonus

Equity

Comprehensive benefits

Job summary

Mirador Therapeutics, Inc. in San Diego, CA, is seeking a Senior Director, Clinical Pharmacology to lead Phase 1 programs from concept to study report.

You will own protocol development, vendor management, and data interpretation to drive dose selection and program strategy. The role requires 10+ years in biotech/pharma with hands-on experience in PK/PD modeling, regulatory writing, and cross-functional leadership.

Qualifications

• PhD, PharmD or equivalent experience in clinical pharmacology or related field.
• 10+ years of biotech/pharma experience in early clinical development.
• Proven track record as Study Director or sponsor lead on Phase 1 studies.
• Experience with IND maintenance and regulatory filings (DSURs, annual reports).
• Strong writing and cross-functional leadership capabilities.
• Familiarity with PK/PD modeling and data interpretation

Responsibilities

• Serve as Study Director for multiple Phase 1 studies from concept to clinical study report.
• Author protocols and amendments; lead cross-functional review and approval.
• Act as day-to-day sponsor interface with Phase 1 units and CROs; manage timelines and budgets.
• Oversee regulatory deliverables for INDs (IND modules, DSURs, annual reports).
• Lead pharmacology input for later-phase programs and due diligence.
• Apply PK/PD and model-informed approaches to dose selection and data interpretation

Skills

Cross-functional leadership

Regulatory writing

Clinical pharmacology

PK/PD modeling

Project management

Study leadership

Communication

Education

PhD or PharmD in relevant field

Tools

Phoenix WinNonlin

NONMEM

R

Job description

Mirador Therapeutics, Inc. in San Diego, CA, is seeking a Senior Director, Clinical Pharmacology to lead Phase 1 programs from concept to study report.

You will own protocol development, vendor management, and data interpretation to drive dose selection and program strategy. The role requires 10+ years in biotech/pharma with hands-on experience in PK/PD modeling, regulatory writing, and cross-functional leadership.