Senior Clinical Pharmacologist I

Overview

• Contribute to advancing drug candidates through development stages using clinical pharmacology and modeling strategies.
• Collaborate with multidisciplinary teams to ensure project objectives are met effectively.
• Provide expertise in pharmacokinetics, pharmacodynamics, and quantitative pharmacology.
• Support regulatory submissions and publications with state-of-the-art modeling techniques.
• Implement strategies for dose selection, trial design, and risk/benefit assessments.
• Ensure compliance with SHE policies, GXPs, and regulatory standards.
• Work in a dynamic environment fostering innovation and collaboration.

Key Responsibilities & Duties

• Lead clinical pharmacology strategies across research and post-marketing stages.
• Conduct PK/PD analyses using advanced modeling and simulation techniques.
• Collaborate with functional teams to achieve study and project goals.
• Provide subject matter expertise on drug-drug interactions and quantitative pharmacology.
• Support development milestones including IND/CTA and marketing applications.
• Develop effective presentations and communications for technical information.
• Ensure adherence to regulatory standards and compliance in clinical pharmacology programs.

Job Requirements

• Doctoral degree in Pharmaceutical Sciences or related field with focus on pharmacokinetics/pharmacodynamics.
• Experience in preclinical or clinical pharmacokinetics, pharmacodynamics, and modeling simulations preferred.
• Proficiency in modeling software like NONMEM and R is advantageous.
• Strong understanding of clinical and quantitative pharmacology principles.
• Familiarity with regulatory guidance for small molecules and biologics.
• Excellent communication skills for conveying complex technical information.
• Ability to thrive in a fast-paced and collaborative environment.
• Creative problem-solving skills in matrixed team settings.