Director, Clinical Pharmacology & Pharmacometrics (Remote)

Jazz Pharmaceuticals, Inc.; Loughton; Remote; GBP 80,000 - 100,000; Full time

Job summary

A global biopharma company in the UK is seeking a Clinical Pharmacology Lead to drive clinical pharmacology studies from phase 1 to phase 4. The role requires a PhD or MD with expertise in clinical pharmacokinetics and regulatory submissions. The ideal candidate will have strong communication and collaboration skills, along with experience in PK/PD analysis using relevant software. This position offers the opportunity to impact the development of life-changing medicines.

Qualifications

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

Responsibilities

• Lead efficient clinical pharmacology studies from phase 1 to phase 4.
• Support clinical study protocol development and data analysis.
• Serve as clinical pharmacology lead and contribute to dose selections.

Skills

Clinical pharmacokinetics expertise

Data analysis

Regulatory submissions experience

Strong communication skills

Team collaboration

Education

PhD or MD

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.