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 collaborate with external CRO’s and internal functional areas including Clinical Development, Project Management, and Toxicology to design, develop and implement strategies to advance nonclinical studies in hematologic cancers and solid tumors.

Essential Functions

• Design and execute experiments to elucidate efficacy, tolerability, biomarkers of efficacy and mechanism of action of small molecule drugs and biologics.
• 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.
• Experience running biochemical or cellular assays, quantitative analysis and biological sample preparation.
• Serve as ED team member and/or lead major pharmacology activities.

Required Knowledge, Skills, and Abilities

• 5-8 years of industry experience in directing or outsourcing preclinical research model development, and investigation of therapeutic potential of drug candidates.
• Experience in managing contract laboratories and sourcing or managing pharmacology programs at a contract laboratory.
• Experience with the translational sciences such as development of disease models, evaluation of mechanism of action, PK/PD/efficacy relationships, predictive and pharmacodynamics biomarker development and drug mechanism of action in preclinical and clinical settings.
• Experience working on exploratory prognostic and PD biomarker identification and assessment in preclinical and clinical samples in rare diseases.
• Ability to independently design and execute experiments to elucidate efficacy, tolerability, biomarkers of efficacy, mechanism of action of small molecule drugs and biologic products.
• Ability to integrate preclinical and clinical data is essential, as is an ability to innovate and apply novel methods to projects.
• 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.
• Must be detail oriented with strong documentation and organizational skills.
• 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/Preferred Education and Licenses

• Education: Doctoral degree (PhD) in biology, biochemistry or relevant discipline and 5-8 years of experience developing nonclinical models for the characterization of therapeutic efficacy and/or pharmacodynamics

Jazz Pharmaceuticals is an Equal Opportunity Employer.