This individual will be responsible for leading oncology non-clinical pharmacology activities in the Early Development (ED) Department. Primary responsibilities of Pharmacology function at Jazz is to establish PK/PD/efficacy relationships and exploring drug mechanism of action, identify predictive disease models and biomarkers, in preclinical settings, to drive the discovery and development of Jazz products and drug candidates. This individual will be able to work independently and within ED and project teams to generate study designs, protocols, review and author reports and co-author primary and secondary pharmacodynamics sections of regulatory documents. The scientist is expected to identify, generate and execute study protocols with external CRO’s. Collaborate with and represent the ED function at internal functional teams including Clinical Development and Operations, Project Management, Bioanalytics and Toxicology to design, develop and implement and monitor execution of strategies and short and long term experiments to advance non-clinical studies in both hematologic cancers and solid tumors.
Essential Function
• Design and execute experiments to elucidate efficacy, tolerability, mechanism of action biomarkers of efficacy of complex combinations of novel small molecule and biological therapeutics.
• Experience running biochemical or cellular assays, quantitative analysis and biological sample preparation.
• Excellent communication skill with ability to function within ED and in matrixed, cross functional teams.
• Ability to independently design experiments, and analyze experimental data and present results in both non-clinical and cross-functional team settings.
• Collaborate with CROs to outsource studies, design via protocols, manage program timing, and costs and with academic labs for Jazz-sponsored research.
• Serve as ED team member and/or lead major pharmacology activities.
• 7-9 years of industry experience investigating therapeutic potential of drug candidates from hit to lead thru lead optimization and IND enabling studies is required.
• Diverse background in preclinical oncology with a focus on novel and emerging therapeutic technologies and applications.
• A robust, experience-based understanding of the intersection of cancer signaling pathways and how they can be leveraged for therapeutic advantage.
• Experience with identification, development and management of multiple complex pharmacology programs at diverse external contract laboratories.
• Ability to independently design and execute experiments to elucidate efficacy, tolerability, biomarkers of efficacy, mechanism of action of small molecule and biologic therapeutic agents.
• Ability to integrate preclinical and clinical data is essential, as is an ability to innovate and apply novel methods to projects.
• Significant experience with the translational sciences such as development of disease models, evaluation of mechanism of action, PK/PD/efficacy relationships, predictive and pharmacodynamic biomarker development and drug mechanism of action in preclinical and clinical settings.
• Excellent analytical skills with experience in oncology data analysis.
• Ability to work effectively both independently and collaboratively in a dynamic, team-oriented environment.
• Strong working knowledge of MS Office, MS Project and GraphPad Prism.
• Strong self-leadership skills, high ability to self-start, and desire and competence to network widely within Jazz, the scientific community, and regulatory agencies.
• Proven ability to oversee academic research, CRO's and consultants.
• Excellent written and oral communication skills.
• Excellent contingency planning and time management skills and demonstrated ability to manage a number of projects simultaneously.
• Strong problem solving and analytical skills, and be capable of independent and creative thinking.
• Ability to navigate and be successful in a fast-paced, highly-matrixed work environment.
• Embody and model Jazz core values.
Required Education and Licenses:
• Doctoral degree (PhD) in biology, biochemistry or relevant discipline is required and 7-9 years of experience developing nonclinical models for the characterization of therapeutic efficacy and/or pharmacodynamics.
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.