Senior Director of Clinical Pharmacology - Remote

Overview

The Senior Director of Clinical Pharmacology will play a pivotal role in leading our clinical pharmacology efforts to advance the development of our cutting-edge antibody portfolio. This position requires a strategic leader who can integrate clinical pharmacology and pharmacokinetics/pharmacodynamics (PK/PD) strategies into our drug development programs to ensure efficacy, safety, and regulatory success.

In Short

• Lead the strategic planning and execution of clinical pharmacology studies, including PK/PD modeling, dose-response analysis, and bioequivalence studies.
• Collaborate closely with cross-functional teams, including clinical development, non-clinical development, DMPK, regulatory affairs, and clinical operations.
• Oversee the development and implementation of modeling and simulation strategies to predict drug behavior.
• Provide expert guidance on clinical pharmacology topics to regulatory submissions and interactions with health authorities.
• Stay abreast of emerging trends and regulations in clinical pharmacology and antibody development.

Requirements

• Ph.D. in Pharmacology, Pharmaceutical Sciences, or related field.
• A minimum of 10 years of experience in clinical pharmacology within the pharmaceutical or biotechnology industry.
• Proven track record of accomplishment in drug development.
• Extensive experience with regulatory submissions and interactions with health authorities.
• Strong analytical and problem-solving skills, with expertise in PK/PD modeling and simulation.

Benefits

• Opportunity to work in a fast-paced, highly dynamic environment.
• Market-competitive compensation and benefits package.
• Unlimited PTO.
• Two, one-week company-wide shutdowns each year.
• Commitment to growing you professionally and providing access to resources.
• 100% remote team with frequent in-person meetings.