Director, Clinical Pharmacology
EPM Scientific · California, United States · 2 wk ago
RemoteRemoteScience$200k–$260k/yrFull-time
Key Responsibilities
- Lead target validation and project strategy for cardiovascular/metabolic/obesity disease programs, driving data-driven decisions from target assessment to experimental validation.
- 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.
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.