Distinguished Scientist, Clinical Research

MSD•Rahway, NJ

4d•Hybrid

About The Position

The Distinguished Scientist/Executive Director within the Translational Clinical Biomarker team leads a Biomarker Center of Excellence and supervises PhD- and MD-level scientists. The role develops, aligns, and oversees end-to-end biomarker strategy and execution across multiple oncology therapeutic platforms, from pre-first-in-human studies through Phase 3 and beyond. It is based in New Jersey, Pennsylvania, or Boston and reports to the head of the Translational Clinical Biomarker team. The position provides scientific and strategic leadership for translational biomarker efforts across oncology development programs and indications. It works with clinical development and cross-functional stakeholders to formulate testable hypotheses, develop biomarker and translational research strategies, align programs with portfolio strategy, identify risks and gaps, and implement mitigation plans. The role partners with experimental and bioinformatics experts, statisticians, and clinical teams to develop analysis plans and reports, interpret data, and communicate study plans and findings. The role collaborates across asset, early development, product development, clinical trial, discovery, informatics, diagnostics, quantitative modeling, biostatistics, molecular assay, and other functions to author and implement protocol-specific biomarker plans. It evaluates emerging technologies and platforms, engages external key opinion leaders, drives research publications, and works with translational and discovery laboratories to advance projects based on clinical and translational data. It also partners with clinical, biomarker, and companion diagnostics teams; contributes to health authority engagements, registrational efforts, and post-marketing commitments; and provides biomarker expertise to due diligence teams.

Requirements

Ph.D., M.D., or M.D./Ph.D. and a minimum of 15 years of experience in oncology biomarker studies and translational clinical research.
Extensive experience in clinical trial development and execution and a clear strategic view of 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.
A proven track record of collaboration in cross-functional, highly matrixed groups in 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 biomarker/diagnostic development, including biomarker discovery, biomarker and diagnostic development, and early- or late-stage drug development.
Strong scientific expertise in translational research and biomarkers for antibody-drug conjugates and T-cell engagers.
Deep scientific knowledge of cancer biology and cancer immunology.
Strong working knowledge of clinical oncology.
Strong communication and analytical skills, including the ability to interface regularly with broad stakeholders, senior leaders, external clinicians, and scientists.
Direct management experience leading PhD- and MD-level scientists, with a demonstrated commitment to and track record of talent development.
Required skills include antibody drug conjugates (ADC), biomarkers, clinical oncology, clinical studies, clinical trial development, diagnostics development, leadership, people management, strategy, and translational research.

Nice To Haves

Experience communicating with health authorities.
Experience with EU IVDR, China HGRAC, Japan PMDA, and other global markets for biomarker and translational analyses.
Prior experience in oncology drug discovery.

Responsibilities

Oversee cross-functional translational efforts for key oncology therapeutic platforms and biomarker work across clinical product development teams and indications.
Lead a group of PhD- and MD-level scientists embedded in oncology clinical development programs.
Collaborate with clinical development and cross-functional teams to formulate testable hypotheses and develop clinical biomarker and translational research strategies.
Align development team strategies with broader portfolio strategy, identify scientific gaps and risks, develop mitigation plans, and coordinate implementation with matrixed stakeholders.
Collaborate with experimental experts, bioinformatics experts, statisticians, and clinical stakeholders to develop statistical analysis plans, analysis reports, and data communication plans.
Participate in data analysis and interpretation and communicate study plans, updates, and findings across functions.
Collaborate with asset, early development, product development, clinical trial, discovery, informatics, diagnostics, quantitative modeling, biostatistics, molecular assay, and other teams to author and implement protocol-specific biomarker plans.
Incorporate scientific and technical advances into clinical development and evaluate fit-for-purpose novel technologies and platforms for clinical biomarker analysis.
Identify and engage external key opinion leaders for hypothesis-driven collaborations.
Drive publication of biomarker and translational research for studies.
Partner with translational and discovery laboratories to implement preclinical and translational projects informed by emerging clinical and translational datasets.
Partner with clinical, biomarker, and companion diagnostics teams to support biomarker implementation and continuity to companion diagnostics.
Contribute to health authority engagements, registrational efforts, and post-marketing commitments.
Provide translational and biomarker expertise and assessment for due diligence teams.