Senior Manager, Clinical Pharmacology

Overview

• Lead clinical pharmacology efforts in CNS therapeutic area, supporting drug development processes and cross-functional teams.
• Provide expertise in pharmacokinetics, pharmacodynamics, and modeling to optimize dosage regimens.
• Collaborate with multidisciplinary teams to integrate clinical and nonclinical data.
• Contribute to regulatory submissions and interactions with FDA and other agencies.
• Promote model-informed drug discovery through publications and conference presentations.
• Support Phase 1 clinical trials, focusing on healthy volunteer studies.
• Ensure efficient drug development by providing innovative solutions and guidance.
• Act independently within a matrixed clinical development organization.

Key Responsibilities & Duties

• Design clinical programs, trial protocols, analysis plans, and study reports.
• Conduct pharmacokinetic analyses, exposure-response analyses, and simulation-based trial designs.
• Develop and defend model-based strategies to governance boards and regulatory agencies.
• Prepare and review clinical pharmacology components of regulatory documents.
• Collaborate with external partners for journal publications and conference presentations.
• Provide leadership and guidance to project teams and other team members.
• Ensure adherence to regulatory guidelines and standards in clinical pharmacology.
• Manage internal and external personnel for outsourced projects.

Job Requirements

• Ph.D. or Pharm D in Pharmaceutical Sciences, Pharmacometrics, or related field.
• Minimum 4 years of experience in pharmaceutical industry; preferred 5 years.
• Strong understanding of pharmacokinetic theory, modeling, and simulation.
• Proficiency in programming tools like Phoenix; experience with Monolix, R, WinNonlin desirable.
• Knowledge of FDA regulatory guidance and experience with IND, NDA submissions.
• Experience in clinical pharmacology with small molecules and CNS therapeutics.
• Excellent leadership, communication, and time-management skills.
• Ability to work independently and collaboratively in a matrixed environment.