Clinical Pharm Lead

About the role

The Clinical Pharm Lead will oversee the clinical pharmacology aspects of drug development programs, ensuring robust study design, execution, and reporting. This senior position works within a cross‑functional team to integrate pharmacokinetic and pharmacodynamic insights into optimal dosing strategies.

Key responsibilities

• Plan and direct clinical pharmacology components of clinical programs and studies, including design, synopsis preparation and reporting.
• Collaborate with multifunctional study teams to deliver assigned clinical pharmacology studies with overall scientific accountability.
• Develop and implement clinical modeling and simulation plans following model‑informed drug development best practices.
• Apply quantitative methods to integrate PK, PD, patient characteristics and disease states to optimize doses, regimens and study designs.
• Summarize and interpret PK‑PD analysis results and communicate their impact on drug development and clinical use.
• Ensure compliance with Parexel standards, ICH‑GCP, and other applicable regulations.

Required profile

• Keen problem‑solving ability.
• Fluent in oral and written English.
• Fluent in the host‑country language.

Required skills

• Pharmacokinetics (PK) and pharmacodynamics (PD) principles.
• Pharmacology of drug candidates.
• Drug metabolism and drug transport knowledge.
• Formulation sciences and biopharmaceutics.
• Pathophysiology and therapeutic area expertise.
• Quantitative modeling and simulation for drug development.