Principal Scientist
3 weeks ago
Our Company's Oncology organization is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of dauntless, forward-thinking individuals achieves this through an unwavering dedication to supporting accessibility to medicine, providing new therapeutic procedures, and collaborating with governments and payers to ensure that people who need medicines have access to them. At our Company, our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe.
Working with the Asset Development Team (ADT's), early
- & late-stage clinical development teams, the Biomarker (BMx) leads will develop asset-specific clinical biomarker strategy by incorporating critical insight from discovery biology, clinical development, diagnostics, bioinformatics, molecular assay experts, Quantitative Pharmacology Pharmacometrics (QP2) and Biostatistics and Research Decision Sciences (BARDS).
**Location**:this role can be based in Rahway, NJ, Upper Gwynedd, PA, Boston, MA, or S. San Francisco, CA. This position does not offer remote work arrangement and requires daily in-office presence.
KEY RESPONSIBILITIES:
- Identify asset-specific translational deliverables & gaps. Building testable hypothesis & forming BMx strategy: collaborate across different LFs, 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 critical scientific insight to identify gaps and risks, pro-actively 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 LFs 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 KOL’s 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 forementioned line functions to build formal analysis plans, participate in data analysis and interpretation. Effectively communicate the study plan, update and output across different function areas to for optimal impact on projects.
- Contribute to Health Authority engagements; Registrational Effort and Post Marketing Commitments.
- The individual is in translational research and biomarker development for our Company’s Oncology programs. Working with early
- and/or late-stage clinical development teams, he/she will have the opportunity to drive translational research and clinical biomarker development for critical oncology clinical programs. The individual will assume a role in a dynamic, cross-functional environment as a key member in early
- and/or late-stage development teams and work closely with multiple functional line functions in various scientific and operational aspects of translational research and biomarker development.
**Key responsibilities include, but are not limited to the following**:
- Hypothesis-building & strategy forming: collaborate with stakeholders in clinical development team(s), to formulate testable clinical hypothesis and develop clinical biomarker and translational research strategy to test the hypothesis.
- Alignment, risk mitigation & strategy implementation: align the development team strategy with broader portfolio strategy. Build critical scientific insight to identify gaps and risks, pro-actively 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. Effectively communicate the study plan, update and output across different function areas to for optimal impact on projects.
**Specific responsibilities include, but are not limited to the following**:
- Work closely with Product Development Team and/or Early Development Team stakeholders. Set protocol-level, hypothesis-driven translational science and biomarker strategy.
- Collaborate with clinical and companion diagnostic leads, author protocol-specific biomarker plans and ensure their efficient implementation. Co-lead a regularly scheduled biomarker meeting for the development team (s).
- Collaborate with experimental experts, bio-informatics experts, statisticians and clinical stakeholders to build formal statistical analysis plans, analysis reports and data communication pl
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