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Director, Clinical Pharmacology ( Uk Or Us Remote )

10+ years
$188K-$282K / yr.
10 March 3, 2025
Job Description
Job Type: Full Time Education: PhD/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Director, Clinical Pharmacology

Company: Jazz Pharmaceuticals
Location: Remote (UK or US)
Salary Range: $188,000 - $282,000 per year
Job Type: Full-time

Job Description:

The Director of Clinical Pharmacology will lead the clinical pharmacology strategy for multiple Jazz portfolio products, covering all phases of drug development from research to registration and beyond. This role involves PK/PD study design, data analysis, regulatory submissions, and leadership of cross-functional teams.

Key Responsibilities:

1. Clinical Pharmacology Strategy & Study Design

  • Develop and execute clinical pharmacology strategies for multiple programs.
  • Design Phase 1-4 pharmacokinetic (PK) and pharmacodynamic (PD) studies.
  • Develop population PK models and PK/PD analyses for drug development and regulatory requirements.
  • Prepare and review clinical study protocols, reports (CSRs), and regulatory documents (INDs, NDAs, IBs, etc.).

2. Regulatory & Compliance

  • Contribute to regulatory submissions, including INDs, NDAs, and BLAs.
  • Address regulatory agency queries and participate in inspections.
  • Ensure compliance with international regulatory standards and pharmacology principles.

3. Leadership & Cross-Functional Collaboration

  • Direct and manage staff within the Clinical Pharmacology group.
  • Collaborate with cross-functional teams to integrate pharmacology principles into project plans.
  • Identify and manage external consultants and vendors supporting clinical pharmacology studies.

Qualifications:

  • PhD or MD with 10+ years of experience in clinical pharmacokinetics and PK/PD analysis.
  • Strong expertise in clinical pharmacology, pharmacometrics, and drug development.
  • Proficiency in PK/PD software (e.g., Phoenix WinNonlin, R, ADAPT, NONMEM).
  • Experience in regulatory agency interactions and global regulatory requirements.
  • Excellent communication, leadership, and presentation skills.
  • Ability to work independently and collaboratively across teams.

Compensation & Benefits:

  • Base salary: $188,000 - $282,000 per year (US-based candidates).
  • Bonus & equity incentives based on performance.
  • Comprehensive benefits package, including medical, dental, vision, 401K, and flexible paid vacation.