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.
Provide leadership in design, implementation, oversight, analysis and reporting of nonclinical toxicology and safety programs to support small and large molecule drug development including GLP toxicology studies through registration and post-marketing stages.
Essential Job Functions:
This position has varying responsibilities relating to nonclinical drug development, which include but are not limited to:
* Establishing the overall strategic direction for the toxicology and safety assessment group and establish objectives consistent with the company's and research & development organization's goals.
* Taking full accountability for the characterization of nonclinical safety and toxicological profile including the safety and risk/benefit of a molecule required from a development and regulatory perspective to take a project from its existing or concept stage to commercialization and post-marketing
* Planning, preparing and reviewing drug development plans and regulatory filings. This involves determining the scope, protocol design study planning & oversight, data review / analysis / interpretation, and reporting for individual safety pharmacology, toxicokinetic, and investigative and regulatory toxicology studies implemented to support nonclinical assessment and development.
* Selection and management of nonclinical CROs performing non-GLP and GLP nonclinical studies. Initiate and manage contracts, coordinate activities with contract laboratories and academic partners
* Contribute to Early Development departmental processes such as SOP's and templates
* Ensure a high quality of work and compliance to appropriate regulatory guidances are followed, including the Good Laboratory Practice (GLP) regulations, ICH, and other regional guidance documents for safety assessment of biopharmaceutical molecules.
* Represent Jazz in interactions with regulatory agencies and respond to regulatory inquires related to nonclinical content. Responsibilities would also include describing results of these studies in various regulatory documents (INDs, NDAs, IBs, etc.)
* Participation on cross functional teams as an Early Development representative to ensure proper integration of these activities into overall project plans
* Partner with and provide subject matter expertise to key internal constituencies (regulatory, Quality, Clinical, CMC and formulations, Drug safety, Medical affairs) and their external contractors or collaborators.
* Participate in the evaluation of potential in-licensing candidates. Serve as early development sciences representative on teams evaluating candidates for in-licensing or risk sharing opportunities
* Working with Finance and Project management, prepare an annual budget of each program, monitor expense and FTEs against budget and priority of work, and evaluate staffing needs for successfully completing assigned nonclinical assessment within timeline.
* A PhD, MD, or equivalent is required in Pharmacology, Toxicology, or related discipline.
* DABT is preferred.
* 10 or more years of related experience in the pharmaceutical or biotechnology industry, demonstrating a broad and proven understanding of drug development.
* Thorough working knowledge of GLP regulations, FDA and ICH nonclinical guidance documents
* Ability to work effectively independently and in teams, with peers, and with senior management to move projects forward.
* Proven ability to manage CRO's and consultants
* Excellent written and oral communication skills
* Ability to think critically and solve problems
* Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
* Embody and model Jazz Pharmaceuticals core values (integrity, collaboration, passion, pursuit of excellence and innovation)
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.