Senior Clinical Pharmacology Scientist

Overview

• Drive the development of groundbreaking therapeutics through advanced clinical pharmacology expertise and innovative approaches to drug development.
• Apply pharmacokinetic and pharmacodynamic principles to analyze and interpret complex clinical data effectively.
• Collaborate with multidisciplinary teams to optimize therapeutic strategies and ensure successful project outcomes.
• Contribute to protocol development, study execution, and comprehensive data analysis for clinical trials.
• Utilize modeling and simulation techniques to inform decision-making in drug development processes.
• Maintain compliance with regulatory standards and contribute to documentation for submissions.
• Stay updated on advancements in clinical pharmacology and pharmacometric methodologies.
• Provide critical insights to drive innovation and enhance therapeutic efficacy.

Key Responsibilities & Duties

• Represent Clinical Pharmacology in cross-functional teams, providing expert guidance on pharmacokinetic and pharmacodynamic strategies.
• Lead the analysis, interpretation, and reporting of pharmacokinetic and pharmacodynamic data.
• Conduct PKPD modeling and simulation to support development decisions and optimize therapeutic approaches.
• Prepare regulatory submissions, including briefing documents, INDs, CTAs, and NDAs, ensuring compliance and precision.
• Collaborate with research, bioanalytical, clinical, regulatory, and statistical teams to advance project goals.
• Contribute to the design and execution of clinical studies, ensuring robust data collection and analysis.
• Stay abreast of literature and advancements in clinical pharmacology and pharmacometric techniques.
• Provide expertise in pharmacometric software and principles to enhance project outcomes.

Job Requirements

• Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics, or related field; 2-3 years of industry experience preferred.
• Strong knowledge of PKPD principles, modeling, simulation, and clinical pharmacology.
• Proficiency in pharmacometric software such as R, Phoenix WinNonlin, and NONMEM.
• Excellent verbal and written communication skills for collaboration and documentation.
• Ability to work effectively in a matrixed team environment with strong interpersonal skills.
• Experience in regulatory documentation and protocol development for clinical trials.
• Commitment to continuous learning and staying updated on clinical pharmacology advancements.
• Preferred experience in advanced pharmacometric principles and their application in drug development.