• 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
• This role reports to the Head of Translational Oncology

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 Working with ADT’s, early-, late-stage clinical development teams, Oncology discovery & other translational groups, the BMx leads will develop program-specific clinical biomarker strategy by incorporating critical insight from discovery biology, clinical development, diagnostics, bioinformatics, molecular assay experts, Quantitative Modeling and Biostats

• 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
• Analysis, interpretation & impact: collaborate with line function experts to build formal analysis plans, participate in data analysis and interpretation
• 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

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• 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

Biomarker Development, Biomarker Research, Clinical Development, Clinical Research, Diagnostics Development, Drug Development, Immuno-Oncology, Oncology, Oncology Research, Risk Mitigation, Strategy Development, Translational Medicine, Translational Research

An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable
• We offer a comprehensive package of benefits
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits