Distinguished Scientist, Clinical Research

Job Description

Distinguished Scientist, Translational Clinical Biomarkers

The Distinguished Scientist/Executive Director within our Translational Clinical Biomarker team, will lead one of our company's Biomarker Centers of Excellence, supervising PhD-/MD-level scientists, developing and overseeing end-to-end biomarker strategy development, alignment and execution for multiple oncology therapeutic platforms, from pre-FIH to Phase 3 clinical studies and beyond. This New Jersey, Pennsylvania or Boston-based position reports to the head of the Translational Clinical Biomarker team.

Primary Responsibilities:

• Oversight on cross-functional translational effort on key oncology therapeutic platforms.
• Oversight of translational biomarker efforts across clinical product development teams, in multiple indications.
• Lead a group of PhD-/MD-level scientists who are embedded in oncology clinical development programs.
• Hypothesis-building & definition of strategy: collaborate with stakeholders in clinical development team(s) and cross-functional translational teams, to formulate testable hypothesis and develop clinical biomarker and translational research strategy to test the hypothesis.
• Alignment, risk mitigation and strategy implementation with an enterprise mindset: align the development team strategy with broader portfolio strategy. Build critical scientific insights to identify gaps and risks, proactively develop mitigation plans. Work with matrixed stakeholders to ensure implementation.
• Collaborate with experimental experts, bio-informatics experts, statisticians and clinical stakeholders to build formal statistical analysis plans, analysis reports, and data communication plans. Participate in data analysis and interpretation.
• Effectively communicate the study plan, update and output across different function areas for optimal impact on projects.

• 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. Explore fit-for-purpose novel technologies/platforms to enable clinical biomarker analysis.

• 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.

• Interface with translational and discovery laboratories to drive implementation of preclinical/translational projects based on emerging clinical/translational datasets.
• Incorporate cutting edge scientific and technical advances to support clinical developments. Form close partnership with clinical, BMx and companion diagnostics to ensure their efficient BMx implementation and seamless continuum to companion diagnostics.

• Contribute to Health Authority engagements, registrational efforts and Post Marketing Commitments.

• Provide Translational and biomarker expertise/assessment for due diligence teams

Education Minimum Requirements:

PH.D. M.D or M.D./Ph.D. with a minimum of 15 years' experience in oncology biomarker studies and translational clinical research

Required Experience and Skills:

• Must have extensive experience in clinical trial development and execution; clear strategic view on the translational needs in clinical studies; experience with experimental and bioinformatic aspects of translational research and biomarker development.
• Strong leadership skills in a matrixed team environment are essential. Proven track record in cross-functional, highly matrixed collaborative groups on drug discovery and/or clinical development.
• A proven track record in biomedical research, scientific scholarship and achievement;
• In-depth understanding of end-to-end drug and BMx/diagnostic development, with experience in biomarker discovery, biomarker and diagnostic development, and early or late drug development.
• Strong scientific expertise on translational and biomarkers over antibody-drug conjugates and T cell engagers. Deep scientific knowledge on cancer biology, and cancer immunology. Strong working knowledge of clinical oncology.
• Strong communication and analytical skills to regularly interface with broad stakeholders including senior leadership within the organization, as well as with external clinicians and scientists.

• Experience in communication with health authorities; experience with EU IVDR, China HGRAC, Japan PMDA, and other global markets for BMx and translational analyses strongly preferred.

• Prior direct management experience leading a team of PhD-/MD-level scientists with a demonstrated passion for and track record of talent development required
• Prior experience in drug discovery in oncology strongly preferred

Required Skills:

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