Director, Clinical Pharmacology & Pharmacometrics (Remote)

Jazz Pharmaceuticals, Inc.; Harrow; Remote; GBP 70,000 - 90,000; Full time

Job summary

A global biopharma company is seeking a Clinical Pharmacology Lead to lead and innovate pharmacology studies from phase 1 to phase 4. The ideal candidate will have a PhD or MD with experience in clinical pharmacokinetic studies and a strong understanding of the drug development process. Key responsibilities include supporting regulatory submissions and collaborating with cross-functional teams to drive clinical strategies.

Qualifications

• Significant experience in clinical pharmacokinetic and pharmacokinetic-pharmacodynamic studies.
• Strong understanding of the drug development process.
• Good working knowledge of software for PK/PD analysis.

Responsibilities

• Lead clinical pharmacology strategy from phase 1 to phase 4.
• Support clinical study protocol development and PKPD data analysis.
• Contribute to regulatory submissions and address queries from regulatory agencies.

Skills

Clinical pharmacokinetic studies

Data analysis and interpretation

Collaboration with cross-functional teams

Regulatory submissions

Presentation skills

Education

PhD or MD in a relevant field

Tools

Phoenix WinNonlin

R

ADAPT

NONMEM

Job 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

• 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

Qualifications

• 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

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options.