Senior Director, Clinical Pharmacology - Phase 1 Leader

Mirador Therapeutics, Inc.

San Diego (CA)

On-site

USD 250,000 - 300,000

Full time

6 days ago

Be an early applicant

Application generator

Turn this role into an interview — a resume and cover letter built around what this employer wants.

Get past ATS filters

Job summary

Mirador Therapeutics, Inc. is seeking a hands-on Senior Director, Clinical Pharmacology to lead Phase 1 studies from concept through to reporting.

You will own protocol authoring, budget and vendor management, and collaborate across Clinical Operations, R&D, Medical Writing, Regulatory Affairs, Biostatistics and Data Management. The role requires a PhD/PharmD with 10+ years in early clinical development, with proven Study Director experience and strong PK/PD modeling and regulatory writing

Qualifications

PhD, PharmD or equivalent in clinical pharmacology or related field with program delivery experience.
10+ years in biotech/pharma early clinical development and Phase 1 delivery as sponsor lead.
Experience as Study Director on first-in-human studies and IND maintenance.

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 dose selection.
Interface with Phase 1 units and CROs; manage start-up, enrollment, dosing and data flow.
Partner with medical monitor for safety reviews; lead dose-escalation meetings.
Contract and manage study vendors; ensure quality, timelines and budget commitments.
Own data quality from first subject to database lock; oversee PK/PD data and sample logistics.
Lead study analysis and reporting; contribute to SAPs and clinical study reports.