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Merck · 4 days ago

Senior Principal Scientist, Oncology Translational Science and Clinical Biomarkers

USA - Pennsylvania - Upper Gwynedd

Full-time

Hybrid

Senior Level, Lead/Staff

$206K/yr - $325K/yr

10+ years exp

Merck is a leading global healthcare company dedicated to delivering breakthrough innovations that improve the lives of cancer patients worldwide. The Senior Principal Scientist will drive translational research and clinical biomarker development for oncology programs, collaborating with cross-functional teams to formulate strategies and ensure the successful implementation of clinical biomarker plans.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

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

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

Qualification

OncologyTranslational ResearchBiomarker DevelopmentClinical DevelopmentImmuno-OncologyClinical ResearchDiagnostics DevelopmentDrug DevelopmentRisk MitigationStrategy DevelopmentBiomedical ResearchAnalytical SkillsCommunication SkillsInterpersonal Skills

Required

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

Experience in clinical trial development and execution; clear strategic view on the translational needs in clinical studies; experience & familiarity with experimental and bioinformatic aspects of translational research and biomarker development

Ability to demonstrate a broad understanding of the end-to-end drug and diagnostic development process, and specific expertise in oncology, preferably immuno-oncology

Possess communication and analytical skills to regularly interface with a wide variety of stakeholders within the organization, as well as with external clinicians and scientists

Track record in cross-functional, highly matrixed collaborative groups on drug discovery and/or clinical development

Strong interpersonal skills, as well as the ability to function in a team environment

A proven track record in biomedical research

Demonstrated record of scientific scholarship and achievement