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

Merck & Co 4 Locations Updated 22 October 2026
PharmaBiotechPharmacovigilanceClinical ResearchRegulatory AffairsQuality Assurancemedicalpharmacovigilancebiostatisticsregulatory submissionemacrorave

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 Early Development organization. Support the development of clinical and scientific content for governance discussions, program reviews, and senior management communications. Present cross-study insights, scientific assessments, and key issues to cross-functional leaders and governance bodies, as appropriate. Help ensure that portfolio and governance discussions are informed by sound scientific judgment and clinically meaningful interpretation of available data. Translate portfolio priorities into Clinical Science strategies, capabilities, and resource plans. People Leadership and Capability Building Provide direct management for Directors, Principal Scientists, and Clinical Scientists, as appropriate. Set clear expectations for scientific quality, strategic thinking, collaboration, and effective communication. Support the development of Clinical Science talent through coaching, mentoring, feedback, and the creation of development opportunities. Promote consistency in role expectations and ways of working across Clinical Scientists. Foster a culture of accountability, collaboration, continuous learning, and high performance. Cross-Functional Leadership Partner closely with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, Drug Safety and Pharmacovigilance, Translational Medicine, Medical Affairs, and other key partner functions. Represent Clinical Science in cross-functional planning, program discussions, and strategic decision-making forums. Facilitate alignment across studies, programs, and functions to support consistent scientific approaches and effective portfolio execution. Support clear communication of clinical and scientific issues to relevant stakeholders and leadership teams. Compliance and Continuous Improvement Ensure Clinical Science activities are conducted in accordance with applicable regulatory requirements, company policies, and established procedures. Support inspection readiness and appropriate documentation of Clinical Science contributions, as applicable. Identify opportunities to improve the quality, consistency, and effectiveness of Clinical Science work across their disease area. Maintain awareness of relevant scientific, clinical, and regulatory developments in their disease area or therapeutic focus to inform disease area strategy and Clinical Science practices. <span styl

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