Distinguished Scientist, Clinical Research

MSD • Boston, MA

1d • $255,800 - $402,700 • 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 and oversees end-to-end biomarker strategy, alignment, and execution across multiple oncology therapeutic platforms, from pre-FIH through Phase 3 clinical studies and beyond. The position is based in New Jersey, Pennsylvania, or Boston and reports to the head of the Translational Clinical Biomarker team.

The role partners with clinical development, translational, discovery, diagnostics, informatics, statistics, and other teams to shape and implement biomarker strategies. It applies scientific and technical advances to clinical development, supports health authority engagements and registrational efforts, and contributes translational and biomarker expertise to due diligence. The position is hybrid, has a day shift, requires 25% travel, and may be eligible for an annual bonus and long-term incentive, if applicable.

Requirements

• Ph.D., M.D., or M.D./Ph.D.
• At least 15 years of experience in oncology biomarker studies and translational clinical research.
• Extensive experience in clinical trial development and execution, with 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 and a proven record of collaboration across cross-functional groups in drug discovery and/or clinical development.
• Proven track record in biomedical research, scientific scholarship, and achievement.
• In-depth understanding of end-to-end drug and BMx/diagnostic development, including biomarker discovery and development, diagnostic development, and early- or late-stage drug development.
• Strong translational and biomarker expertise in antibody-drug conjugates and T-cell engagers; deep knowledge of cancer biology and cancer immunology; and strong working knowledge of clinical oncology.
• Strong communication and analytical skills, including the ability to engage senior organizational stakeholders and external clinicians and scientists.
• Direct experience managing a team of PhD- or MD-level scientists, with a demonstrated commitment to and track record of talent development.
• Required skills listed: Antibody Drug Conjugates (ADC), Biomarkers, Clinical Oncology, Clinical Studies, Clinical Trial Development, Diagnostics Development, Leadership, People Management, Strategic, and Translational Research.

Nice To Haves

• Experience communicating with health authorities; experience with EU IVDR, China HGRAC, Japan PMDA, and other global markets for BMx and translational analyses is strongly preferred.
• Prior experience in oncology drug discovery is strongly preferred.

Responsibilities

• Lead a Biomarker Center of Excellence and oversee cross-functional translational efforts on key oncology therapeutic platforms.
• Oversee translational biomarker efforts across clinical product development teams and multiple indications.
• Lead PhD- and MD-level scientists embedded in oncology clinical development programs.
• Collaborate with clinical development and cross-functional translational stakeholders 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 and proactively develop mitigation plans.
• Work with matrixed stakeholders to ensure strategy implementation.
• Collaborate with experimental, bioinformatics, statistical, and clinical experts to develop formal statistical analysis plans, analysis reports, and data communication plans; participate in data analysis and interpretation.
• Communicate study plans, updates, and outputs across functional areas to maximize project impact.
• Collaborate with Asset Development, Early Development, Product Development, Clinical Trial, Discovery, Informatics, Diagnostics, quantitative modeling, Biostatistics, Molecular Assay, and other teams to author protocol-specific biomarker plans and support implementation.
• Evaluate scientific and technical advances and novel technologies or platforms for clinical biomarker analysis.
• Identify and engage external key opinion leaders in hypothesis-driven collaborations and drive publication of biomarker and translational research.
• Interface with translational and discovery laboratories to implement preclinical and translational projects based on emerging clinical and translational datasets.
• Partner with clinical, BMx, and companion diagnostics teams to ensure effective 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.

Benefits

• Medical, dental, and vision healthcare benefits and other insurance benefits for employees and their families.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Annual bonus and long-term incentive, if applicable.
• Domestic relocation.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree