Director of Structural Engineering

Jazz Pharmaceuticals, Inc.; City of Westminster; On-site; GBP 125,000 - 150,000; Full time

Job summary

A leading biopharmaceutical company in the United Kingdom seeks a skilled Clinical Pharmacology Lead to guide innovative studies from phase 1 to phase 4. The successful candidate will develop pharmacology strategies, analyze data, and ensure regulatory compliance throughout the drug development process. Applicants must have a PhD or MD with substantial experience in clinical pharmacokinetics and pharmacodynamics, and a strong understanding of regulatory submissions and agency interactions. This role offers competitive benefits including medical, dental, and retirement savings plans.

Benefits

Medical insurance

Dental insurance

Vision insurance

Retirement savings plan

Flexible paid vacation

Qualifications

• Significant experience in clinical pharmacokinetic and pharmacodynamic studies.
• Strong understanding of the drug development process.
• Collaborative and flexible in interactions.

Responsibilities

• Lead clinical pharmacology studies from phase 1 to phase 4.
• Develop clinical pharmacology strategy for multiple programs.
• Support clinical study protocol development and data analysis.

Skills

Clinical pharmacology

Data analysis/interpretation

Working knowledge of PK/PD software

Regulatory submissions

Education

PhD or MD

Tools

NONMEM

Phoenix

Job description

Identify and manage consultants and vendors supporting clinical pharmacology studies. Contribute to the timely publication and/or presentation of clinical pharmacology and pharmacometrics data.

Responsibilities:

• Lead efficient, innovative, clinical pharmacology and/or PK/PD studies from phase 1 to phase 4.
• Develop 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, PK/PD data analysis/interpretation, and study report.
• Serve as clinical pharmacology lead at cross‑functional teams, responsible for dose selection and rationale in phase 1 studies and contribute to dose selections beyond phase 1.
• Collaborate with the pharmacometrics lead and relevant cross‑functional teams to plan and support PK/PD modeling for internal or regulatory decision making.
• Contribute to preparation of relevant sections of regulatory submissions (IND, NDA/BLA).
• Address queries from regulatory agencies during reviews and inspections.

Qualifications:

• PhD or MD with significant years of experience in clinical pharmacokinetic and pharmacodynamic studies and data analysis/interpretation.
• Strong understanding of clinical pharmacology and pharmacometrics principles and the drug development process.
• Good working knowledge of software for PK/PD analysis (e.g., NONMEM, Phoenix).
• Experience in regulatory submissions and agency interactions related to INDs, CTDs, NDAs or BLAs.
• Collaborative and flexible in personal interactions at all levels of the company.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.