Role Description
This individual will be responsible for leading scientific team members assigned to oncology assets ranging from discovery through regulatory approval. This individual will both manage the oncology pharmacology team and serve a lead on one or more programs themselves.
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Establishing efficacy in relevant disease models.
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Demonstrating differentiation relative to relevant comparators.
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Determining PK/PD/efficacy relationships.
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Characterizing mechanisms of action.
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Identifying predictive disease models, indications, and biomarkers.
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Driving preclinical discovery.
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Supporting research and development of Jazz products and drug candidates overall.
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Designing and executing studies that address clinically relevant priorities.
Operational tasks include:
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Designing and executing experiments that are outsourced or performed by in-house bench researchers or academic collaborators.
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Reviewing and contributing to clinical protocols.
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Reviewing and authoring technical reports.
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Coauthoring sections of regulatory documents ranging from IND to NDA/BLA submissions.
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Communicating relevant research at internal and external forums.
The oncology pharmacology team is cross-functional, including participation in matrix teams assigned to specific products that include but are not limited to Clinical Development, Bioanalytical, Toxicology, Clinical Pharmacology, Biomarkers Regulatory Affairs, and Project Management.
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Collaborate with and represent ORP on internal teams to design, develop, implement, and oversee execution of strategies and experiments supporting nonclinical studies in hematologic malignancies and solid tumors.
Qualifications
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Industry experience evaluating therapeutic potential of drug candidates from hit to lead optimization through IND enabling studies, with deep expertise in oncology drug development.
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Broad background in preclinical oncology with strong familiarity with emerging therapeutic modalities, competitive landscapes, and strategic assessment of diverse drug mechanisms.
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Extensive experience in Immuno Oncology (I/O), including I/O relevant in vivo and in vitro models, immune cell biology, and integration of immunological endpoints into pharmacology programs.
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Demonstrated experience working across multiple drug modalities, including small molecules, biologics, ADCs, bi-specifics, T cell engagers, cell and gene therapies, and RNA based therapeutics.
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Strong foundational understanding of the interdependencies between Nonclinical Pharmacology, Toxicology, DMPK, and Clinical Pharmacology.
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Deep understanding of cancer signaling pathways and their therapeutic exploitation.
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Proven experience leading multiple complex pharmacology programs at diverse CROs, including GLP and non-GLP environments.
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Expertise designing and executing studies evaluating efficacy, tolerability, mechanism of action, and biomarker strategies for small molecule and biologic agents.
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Ability to integrate preclinical and clinical datasets, innovate, and apply novel methodologies to advance therapeutic programs.
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Proficiency with analytical tools (e.g., GraphPad Prism) and biomarker data analysis.
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Direct people management experience, including mentorship, performance development, and leadership of scientific teams.
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Strong leadership qualities, self-motivation, and demonstrated success networking across internal teams, academia, industry, and regulatory agencies.
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Excellent ability to assess program needs, oversee CRO activities, develop/review protocols, monitor execution, interpret results, and prepare high quality reports for regulatory submissions.
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Experience authoring nonclinical components of IND, NDA/BLA/MAA submissions, briefing packages, DSURs, IBs, and fast track designation documents.
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Strong project management skills with the ability to manage multiple complex programs simultaneously.
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Demonstrated success leading in fast paced, highly matrixed environments, aligning diverse stakeholders and driving decision making.
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Strong analytical and creative problem-solving skills.
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Embody and model Jazz core values.
Requirements
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Ph.D. in biology, biochemistry, immunology, pharmacology, or a related discipline.
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Experience leading early oncology programs and developing nonclinical models for characterizing therapeutic efficacy and pharmacodynamics, including substantial oncology and immuno-oncology experience.
Benefits
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Medical, dental and vision insurance.
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401k retirement savings plan.
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Flexible paid vacation.
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Discretionary annual cash bonus or incentive compensation.
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Discretionary equity grants in accordance with Jazzβs Long Term Equity Incentive Plan.