Senior Director, Clinical Science, Oncology Early Development (Hybrid)

Merck; New Jersey; On-site; USD 250,000 - 400,000; Full time

Job summary

Merck, a global biopharma leader, seeks a Senior Director, Clinical Science, Oncology Early Development to steer strategy for novel assets from candidate transition through first-in-human development and clinical proof-of-concept.

You will integrate clinical, PK/PD, biomarker data and external evidence to shape development plans, align cross-functional teams, and elevate scientific rigor across the portfolio in a matrix environment.

Qualifications

• Experience leading Clinical Science in oncology early development.
• Proven ability to integrate translational medicine, biomarker strategy and FIH trial design.
• Strong cross-functional leadership in a matrix environment.

Responsibilities

• Provide strategic Clinical Science leadership across Oncology Early Development programs.
• Guide study design, data interpretation, and decision-making across assets.
• Integrate clinical, PK/PD, biomarker, safety and external data to inform portfolio strategy.
• Lead standardization of Clinical Science practices and contribute to governance discussions.
• Mentor and develop Clinical Scientists within a matrix organization.

Skills

Oncology

Clinical Science Leadership

Biomarker Strategy

Study Design

Cross-functional Leadership

Early Development

Job description

Job Description

The Senior Director, Clinical Science, Oncology Early Development is responsible for providing strategic Clinical Science leadership for novel assets from candidate transition through first-in-human development and clinical clinical proof-of-concept. Reporting to the Executive Director, this role contributes to the early development and scientific platform strategy by applying deep expertise in early-phase oncology, translational medicine, biomarker strategy, and first-in-human (FIH) trail design to shape development plans, strengthen scientific rigor and enable objective, data-driven decision-making across the early oncology portfolio.

The Senior Director integrates emerging clinical, pharmacokinetic, pharmacodynamic, biomarker, safety, and external scientific evidence to inform indication strategy, dose escalation and optimization, cohort expansion, and proof-of-concept assessments. The role partners closely with Section Heads, Asset Leads, Early Program Development Team Leads, study teams, and cross-functional leaders to guide study design, data interpretation, issue resolution, and program decisions.

This role has a strong strategic orientation and is expected to shape how Clinical Science work is performed across the Oncology Early Development portfolio, including standardization of practices, alignment of scientific approaches, and integration of insights across assets. The Senior Director may have responsibility for direct management and development of multiple Clinical Scientists and is expected to provide leadership, coaching, and clear direction within a matrix environment.

The role requires close collaboration with Clinical Operations, Regulatory Affairs, Biostatistics and Data Management, Drug Safety and Pharmacovigilance, Translational Medicine, Medical Affairs, and other key partner functions, as well as contribution to governance discussions and senior leadership reviews.

Key Responsibilities

Early Development and Clinical Science Strategy

• Provide strategic Clinical Science leadership across Oncology Early Development, including multiple studies, programs, and assets.
• Contribute to early clinical development strategy from candidate transition through first-in-human evaluation and clinical proof-of-concept by providing Clinical Science input on development opportunities, scientific considerations, portfolio risks, and implications of emerging internal and external data.
• Partner with Section Heads, Asset Leads, Early Program Development Team Leads, and cross-functional leaders to support alignment of Clinical Science activities with broader program and disease area objectives.
• Integrate disease biology, mechanism of action, translational evidence, competitive landscape, and emerging internal and external data to identify development opportunities, risks, and key decision points.
• Connect insights across studies and assets to inform portfolio decisions and future development.

Standardization and Scientific Consistency

• Establish and advance consistent Clinical Science standards for early development planning, medical data review, dose-escalation meetings, data interpretation, and key deliverables.
• Promote scientific consistency across studies while preserving flexibility for asset-specific biology, modality, and development questions.
• Identify and implement improvements that strengthen decision quality, operational efficiency, documentation, and inspection readiness.
• Maintain awareness of emerging oncology science, early development methodologies, regulatory expectations, and external innovations relevant to the portfolio.
• Help establish and maintain standards, expectations, and leading practices for Clinical Science activities within the portfolio.
• Advocate for the implementation of innovative approaches, including visual analytics, centralized data review, AI-enabled workflows, and other technologies that improve quality and efficiency.

Strategic Scientific Leadership

• Provide senior scientific guidance across assigned studies and programs to support high-quality and consistent Clinical Science input.
• Guide interpretation of clinical data across studies, cohorts, and assets to support a broader understanding of trends, opportunities, risks, and program implications.
• Support the identification and evaluation of key clinical, scientific, and data-related issues, and help ensure they are appropriately framed for cross-functional and governance discussions.
• Contribute scientific perspective to protocol development, protocol amendments, study design considerations, endpoint selection, eligibility criteria, biomarker strategy discussions, and other development planning activities.
• Serve as a Clinical Science subject matter expert for Oncology Early Development across study teams and partner functions.

Portfolio and Governance Contribution

• Contribute Clinical Science expertise to portfolio discussions, governance reviews, and senior leadership meetings within the Oncology Ea