Senior Principal Scientist, Oncology Translational Science and Clinical Biomarkers

Overview

Senior Principal Scientist (Sr Director), Oncology Translational Science and Clinical Biomarkers
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Our Company’s Oncology organization is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. The team supports accessibility to medicine, provides new therapeutic procedures, and collaborates with governments and payers to ensure access to medicines. The focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe.

This role is in translational research and biomarker development for Oncology programs. Working with early- and/or late-stage clinical development teams, the role will drive translational research and clinical biomarker development for critical oncology clinical programs. This role reports to the Head of Translational Oncology. The individual will be a key member in a dynamic, cross-functional environment, working with multiple functional line functions in various scientific and operational aspects of translational research and biomarker development.

The role involves collaboration with ADTs, early- and late-stage clinical development teams, Oncology discovery and other translational groups; the BMx leads will develop program-specific clinical biomarker strategy by incorporating insight from discovery biology, clinical development, diagnostics, bioinformatics, molecular assay experts, quantitative modeling and biostats.

Key Responsibilities

• Identify asset-specific translational deliverables & gaps. Build testable hypotheses and form BMx strategy: collaborate across different line functions to formulate testable clinical and translational hypotheses; and develop clinical biomarker and translational research strategy to test the hypothesis.
• Alignment, risk mitigation & strategy implementation: align with asset development team strategy. Build scientific insight to identify gaps and risks, proactively develop mitigation plans. Work with matrixed stakeholders to ensure implementation.
• Collaborate with Asset Development Teams, Early Development Teams, Product Development Teams, Clinical Trial Teams, Discovery, Informatics;
  Diagnostics, quantitative modeling team;
  Biostats, Molecular Assay teams, and other key line functions to author protocol-specific biomarker plans and ensure their efficient implementation.
• Incorporate cutting-edge scientific and technical advances to support clinical developments. Proactively identify and engage external key opinion leaders on specific hypothesis-driven collaborations to complement internal effort. Drive the publication of biomarker and translational research for respective studies.
• Analysis, interpretation & impact: collaborate with line functions to build formal analysis plans, participate in data analysis and interpretation. Effectively communicate the study plan, updates and outputs across function areas for optimal impact on projects.
• Contribute to Health Authority engagements;
  Registrational Efforts and Post Marketing Commitments.
• Hypothesis-building & strategy forming: collaborate with stakeholders in clinical development teams to formulate testable clinical hypotheses and develop clinical biomarker and translational research strategy to test the hypothesis.
• Alignment, risk mitigation & strategy implementation: align development team strategy with broader portfolio strategy. Build scientific insight to identify gaps and risks, proactively develop mitigation plans. Work with matrixed stakeholders to ensure implementation.
• Analysis, interpretation & impact: collaborate with line function experts to build formal analysis plans, participate in data analysis and interpretation. Communicate the study plan and outputs across function areas for optimal impact on projects.

Note: This role is available in Rahway, NJ;
West Point, PA;
Upper Gwynedd, PA;
South San Francisco, CA or Boston, MA based on candidate preference.

Qualifications

• PH.D., M.D. or M.D./Ph.D. with a minimum of 10 years of experience in oncology biomarker studies and translational clinical research

Required Experience and Skills

• Experience…