Senior Manager, Clinical Pharmacology
Posted on Apr 10, 2019 by Jazz Pharma
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.Responsibilities:
This position is responsible for efficient, innovative, clinical pharmacology, PK/PD, and/or population PK study design, analysis, interpretation, and reporting to support international regulatory submissions. You will interact with multidisciplinary groups across the company including clinical development, biostatistics, clinical operations, regulatory, non-clinical, quality and business development.
This position has varying responsibilities in clinical pharmacology, pharmacokinetics and pharmacodynamics which include but are not limited to:
- Assisting in participating in design of the clinical pharmacology component of drug development programs consistent with company and R&D program goals
- Clinical study protocol design, data analysis/interpretation, and reporting of studies by preparing CSRs and various regulatory documents (INDs, NDA's, IB's, etc.)
- This includes determining scope, design, planning and analysis of phase 1-4 pharmacokinetic and pharmacodynamics studies, including developing appropriate population PK models, and PK/PD analysis required from a development and regulatory perspective to take a project from its existing or concept stage to commercialization. Planning, preparing and reviewing drug development plans and regulatory filings
- Identifying and managing consultants and vendors supporting clinical pharmacology studies
- Effective participation on cross functional teams representing early development department to insure integration of modern pharmacology principles into project plans
- Work closely with Bioanalytical Scientists, Project Managers, Clinical Researchers, Biostatisticians and Clinical Trials Managers to support clinical development programs
Required Knowledge, Skills, and Abilities
- PhD or MD required. Experience with clinical pharmacokinetic and pharmacokinetic-pharmacodynamic data analysis, preferred.
- Strong understanding of clinical pharmacology principles and the drug development process
- Working knowledge of Phoenix and other PK/PD software
- Ability to work both independently and on strong cross functional teams
- Demonstrated superior oral and written presentation skills required
- Collaborative and flexible in personal interactions at all levels of the company
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.