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Director, Clinical Pharmacology ( Uk Or Us Remote )

7+ years
$188,000.00 - $282,000.00
10 Dec. 30, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 (UK or US Remote)
Req ID: R009763
Location: Palo Alto, CA [Remote/Home-Based]
Category: Research & Development


About Jazz Pharmaceuticals
Jazz Pharmaceuticals (NASDAQ: JAZZ) is a global biopharmaceutical company committed to transforming the lives of patients and their families. We specialize in developing life-changing medicines for serious diseases, often with limited or no therapeutic options. Our diverse portfolio includes both marketed medicines and novel product candidates across neuroscience and oncology. We are committed to innovation through novel compounds, small molecules, biologics, and cannabinoid science. Headquartered in Dublin, Ireland, Jazz serves patients in nearly 75 countries worldwide.


Position Overview
The Director, Clinical Pharmacology will be responsible for leading the clinical pharmacology strategy across Jazz’s portfolio, from research through to registration and beyond. This role involves overseeing clinical study design, data analysis, and regulatory submissions to support international drug development programs. You will collaborate with cross-functional teams to ensure that clinical pharmacology principles are integrated into project plans, and that pharmacokinetic/pharmacodynamic studies meet development and regulatory requirements.


Essential Functions/Responsibilities

  • Lead the clinical pharmacology strategy for multiple programs, from early development to commercialization.
  • Design clinical study protocols, including the planning, analysis, and reporting of phase 1-4 pharmacokinetic and pharmacodynamics studies.
  • Develop population PK models and PK/PD analysis to support drug development and regulatory filings (IND, NDA/BLA, etc.).
  • Manage the activities of staff within the Clinical Pharmacology group.
  • Contribute to the preparation of regulatory documents, including INDs and NDAs, and respond to queries from regulatory agencies during reviews and inspections.
  • Identify and manage external consultants and vendors supporting pharmacology studies.
  • Collaborate effectively with cross-functional teams, ensuring integration of pharmacology principles into project plans.

Required Knowledge, Skills, and Abilities

  • PhD or MD with 10+ years of experience in clinical pharmacokinetics and pharmacodynamics data analysis.
  • Strong knowledge of clinical pharmacology and pharmacometrics, as well as the drug development process.
  • Proficiency in PK/PD analysis software (e.g., Phoenix WinNonlin, R, ADAPT, NONMEM).
  • Experience with regulatory agency interactions and submissions.
  • Excellent communication skills, including strong presentation abilities.
  • Ability to work independently as well as part of cross-functional teams.

Equal Opportunity Employer
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, veteran status, or any characteristic protected by law.


Compensation
For U.S.-based candidates, the full base pay range for this role is $188,000 - $282,000. Compensation depends on factors such as qualifications, skills, and experience. The successful candidate may also be eligible for a discretionary bonus, equity grants, and a comprehensive benefits package, including medical, dental, vision insurance, 401k, and paid vacation.