Director, Clinical Pharmacology & Pharmacometrics

Director, Clinical Pharmacology & Pharmacometrics

Jazz Pharmaceuticals

London, United Kingdom

Brief Description:

This position is responsible for leading efficient, innovative, clinical pharmacology and/or PK/PD studies from phase 1 to phase 4 through working with cross-functional team members.

Essential Job Functions:

Job Responsibilities

• Development of the clinical pharmacology strategy of multiple programs spanning from candidate nomination for GLP toxicity studies through phase 4;
• Support clinical study protocol (phase 1-4) development, PKPD data analysis/interpretation, and study report;
• Serve as the clinical pharmacology Lead at cross function teams, and responsible for the dose selection and rationale in phase 1 studies and contribute to dose selections in clinical studies beyond phase 1;
• Work with the pharmacometrics lead and relevant cross-function teams to plan and support PKPD modeling for internal or regulatory decision makings;
• Contribute to the preparation of relevant sections of regulatory submissions including IND, and NDA/BLA documents;
• Address queries from regulatory agencies during reviews and inspections;
• Identify and manage consultants and vendors supporting clinical pharmacology studies;
• Contribute to the timely publication and/or presentation of clinical pharmacology and pharmacometrics data.

Required Knowledge, Skills, and Abilities:

• PhD or MD with significant years of experience in clinical pharmacokinetic and pharmacokinetic-pharmacodynamic studies and data analysis/interpretations;
• Strong understanding of clinical pharmacology and pharmacometrics principles and the drug development process;
• Good working knowledge of software for PK/PD analysis (e.g. Phoenix WinNonlin, R, ADAPT and NONMEM);
• Ability to work both independently and on strong cross functional teams;
• Experience in regulatory submissions and agency interactions related to INDs, CTDs, NDAs or BLAs;
• Excellent written and oral communication skills including good presentation skills;
• Collaborative and flexible in personal interactions at all levels of the company.