Director, Oncology Research and Pharmacology

Brief Description:

• This individual will be responsible for leading oncology non-clinical pharmacology activities in the Research and Early Development (RNCD) Department.
• Primary responsibilities of Oncology Research and 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 ORP 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 ORP 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 Functions

• 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.

Required Knowledge, Skills, and Abilities

• Industry experience investigating therapeutic potential of drug candidates from hit to lead through lead optimization and IND enabling studies
• Diverse background in preclinical oncology with a focus on novel and emerging therapeutic technologies and ability to value opportunity in competitive modalities
• Experience with Immune Oncology (I/O) based therapeutic models and experimental design

• 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.

• Strong knowledge of analytical programs, including GraphPad Prism.
• Strong leadership skills, high ability to self-start, and desire and competence to network widely within Jazz, the scientific community, and regulatory agencies.
• An ability to integrate preclinical and clinical data is essential, as is an ability to innovate and explore new science
• Excellent analytical skills with experience in biomarker data analysis
• Must be detail oriented with strong documentation and organizational skills
• Ability to assess program needs and resources, identify and manage CRO studies both GLP and non-GLP
• Prepare and review protocols, monitor study progress, interpret results, coordinate report finalization, and/or prepare quality reports (for due diligence activities and regulatory submissions) for Nonclinical: including, biochemical and cell-based assays, PK/PD, drug interaction, and efficacy
• Excellent written and oral communication skills
• Experience as author of Nonclinical sections of IND and NDA/BLA/MAA, briefing documents, DSUR, IB, Request for Fast Track Designation. Integrate submission information to ensure consistency and quality throughout. Contribute as appropriate to Clinical Overview. Proven ability to oversee academic research and consultants
• Excellent contingency planning and time management skills and demonstrated ability to manage several projects simultaneously
• Strong problem solving and analytical skills, and 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 experience developing nonclinical models for the characterization of therapeutic efficacy and/or pharmacodynamics.

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