Director, Clinical Pharmacology

Associate Director/Director, Pre-Clinical/Clinical Pharmacology

Job Type: Full-time

Salary: $200K - $260K/yr

Location: Remote [must be based in California]

Company Summary: A clinical stage biotech harnessing best-in-class siRNA therapeutics is growing their US clinical team as their studies in US, AUS, and China continue to progress.

Key Responsibilities: Lead target validation and project strategy for cardiovascular/metabolic/ obesity disease programs, driving data-driven decisions from target assessment to experimental validation. IC role directly reporting to CMO.

• Provide strategic insight and technical leadership within the Clinical Pharmacology function.
• Author technical reports and/or regulatory documents for major milestones of clinical development.
• Participate in regulatory interactions and responses to regulatory questions.
• Apply state-of-the-art quantitative modeling, including translational PK/PD, population PK, and exposure-response analyses, to guide recommended phase 2 dose/schedule (RP2Ds) selection for pivotal studies.
• Be responsible for target evaluation through literature mining and internal validation and making information-based target proposals.
• Lead program by making strategy, identifying key milestones, allocating resources, and making data-informed decisions.
• Closely work with internal team and external collaborators to effectively advance the projects.
• Carry out experiments, analyze data and write study reports.

Requirements:

• PhD/PharmD degree or equivalent in biology/pharmacology or related area
• Research training in cardiovascular, metabolic, or obesity diseases.
• Deep understanding of biology pathways in these disease areas and familiar with relevant experience in vitro and in vivo disease models.
• Strong critical thinking and problem-solving skills.
• Good team player, excellent communication skills, learning agility.