Director, Bioanalytical Sciences
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
The Director, Bioanalytical Sciences will report to the Head of DMPK and Bioanalytical Sciences within the Clinical Pharmacology and Nonclinical Safety Department and will provide organizational and scientific leadership for US-based members of the Bioanalytical Sciences group, as well as contribute to the scientific and strategic direction of the global Bioanalytical Sciences group (US and UK) at Jazz. The Bioanalytical Sciences group directs CROs in the development and validation of bioanalytical methods to measure drug concentrations and immunogenicity in all nonclinical and clinical studies across the entire pipeline of small molecules and biologics at Jazz.
- Direct and manage the activities of US staff within Bioanalytical Sciences
- Plan/oversee budgets and resources within the US Bioanalytical Sciences group to ensure alignment with project and corporate goals and objectives
- As a member of the global Bioanalytical Sciences Leadership Team, contribute to the strategic and scientific direction of the Bioanalytical Sciences group across all Jazz sites
- Attract and retain key talent to build and maintain bioanalytical capabilities at Jazz
- Drive alignment with project teams, functional leadership, and governance committees on bioanalytical strategies and resourcing for Jazz’s small molecule and biologic programs
- Serve as the bioanalytical subject-matter expert on cross-functional drug discovery and development project teams
- Provide oversight of bioanalytical CROs to facilitate the transfer, development, and validation of regulated (GLP/GCP) bioanalytical methods and ensure quality data and reports are delivered within specified timelines
- Manage CRO contracts and bioanalytical aspects of project budgets
- Contribute to the preparation of study protocols, reports, and bioanalytical sections of regulatory submissions (e.g., IND, NDA, BLA) and address relevant queries from regulatory agencies
Required Knowledge, Skills, and Abilities
- A minimum of 10 years of experience in the pharmaceutical industry supporting bioanalysis in non-clinical and clinical studies
- Extensive experience developing and validating bioanalytical and immunogenicity methods for small molecules and biologic therapies
- Experience preparing bioanalytical sections of regulatory submission documents (e.g., IND, NDA/BLA) and bioanalytical components of nonclinical and clinical study protocols
- Strong knowledge in GLP/GCP regulations and regulatory guidance documents that apply to bioanalysis
- Excellent written and oral communication skills
- Excellent leadership skills
- Demonstrated ability to effectively influence without authority in a matrix organization
- Proven ability to prioritize and deploy resources appropriately to align with project and corporate objectives
Required/Preferred Education and Licenses
- Doctorate degree in chemistry, analytical sciences, pharmaceutical sciences, or a related field
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.
About the Company
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing, and commercializing meaningful products that address unmet medical needs.We have a diverse portfolio of products and product candidates, with a focus in the areas of sleep and hematology/oncology. We also support commercial products in other therapeutic areas where we can meaningfully address serious medical needs. As part of our unwavering commitment to improve patients’ lives, we are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise. We do this through a growth strategy of growing sales of the existing medicines in our portfolio; acquiring commercial products or product candidates that are in late-stage development; and pursuing focused development of our pipeline of differentiated therapies.