Clinical Pharm Lead

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities:

General Accountabilities

• Plans and directs clinical pharmacology components of clinical programs (including clinical development plan and medicine plan) and studies (including design, synopsis preparation and reporting).

• Works with multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and has overall scientific accountability for the designated studies.

• Accountable for the development and implementation of a clinical modeling and simulation plan based on agreed-upon best practices (i.e. model-informed drug development).

• Responsible for use of quantitative methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development.

• Responsible for appropriate summarization and interpretation of results of pharmacokinetic/pharmacodynamic (PK-PD) analyses with respect to their impact on development and clinical use of drugs

Compliance with Parexel standards

• Comply with required training curriculum.

• Complete timesheets accurately as required.

• Submit expense reports as required.

• Update CV as required.

• Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements.

Skills:

• Demonstrates thorough understanding of the following: 1) principles of PK, PK-PD and pharmacology relevant to drug candidates; 2) other relevant scientific disciplines, including drug metabolism, drug transport, formulation sciences, biopharmaceutics, pathophysiology and therapeutics; and 3) quantitative modeling and simulation principles.

Knowledge and Experience:

• Keen problem-solving skills.

• Fluent in both oral and written English.

• Fluent in host country language required.

Education:

• Fluent in host country language required.