Pharmacokinetic and Pharmacodynamic Manager

Pharmacokinetic and Pharmacodynamic Manager

Recordati

Milan, Italy

Job Purpose

We are looking for Pharmacokinetic and Pharmacodynamic Manager who will contribute to multi-disciplinary drug development managing and providing an integrated understanding of pharmacokinetics/pharmacodynamics (PK/PD), DMPK properties, and drug interaction (DDI) including model based predictive studies. Manages pharmacokinetic activities and timelines, analyzes and interprets pharmacokinetic data from clinical trials, and assists with other project related tasks identified.

Key Responsibilities

• Represents clinical pharmacokinetic and pharmacodynamics in project teams;
• Manages PK, PK/PD, DMPK, and DDI studies of novel therapies;
• Oversees the workflow and output quality, plans and reports of assigned projects;
• Understand guidelines from the FDA, EMA, or other regulatory agencies as they apply to PK analysis and model based drug development for each project;
• Advise and write clinical and non-clinical sections of Medicinal Product Dossiers;
• Document, analyze, create summaries, and present results in written and verbal form to team and stakeholders;
• Ensure adherence to all departmental systems and SOPs.

Required Education

• Ph.D. or equivalent education in Pharmaceutical Sciences, Pharmacology, Biomedical Engineering, Biochemistry, or relevant fields.

Required Skills and Experience

• 5+ years relevant experience;
• Good written and oral communication skills;
• Attitude to team work;
• Ability to work on multiple tasks under pressure;
• Experience in interacting with regulatory bodies;
• Ability to utilize modelling and simulations software is a plus.

Required Languages

• Fluent in English.