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

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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

Core Leadership Skills

• Sets clear direction aligned with business and organizational priorities.

• Demonstrates strong scientific and strategic judgment in complex and ambiguous situations.

• Builds strong, collaborative relationships across functions and levels.

• Develops people through coaching, feedback, and support for growth.

• Creates an inclusive environment where diverse perspectives are valued.

• Drives accountability and high standards for quality and performance.

• Communicates clearly and effectively with team members, cross-functional partners, and senior leaders.

• Leads through influence in a matrix environment and helps teams align around shared goals.

• Encourages continuous improvement, learning, and thoughtful challenge.

• Balances enterprise thinking with practical decision-making and timely action.

• Advanced scientific or healthcare degree required (e.g., PhD, PharmD), or equivalent, with 8+ years of pharmaceutical, clinical drug development, and/or medical field experience preferred

• Master’s degree, preferably in life sciences, with 12+ years of pharmaceutical, clinical drug development, and/or medical field experience
• Bachelor’s degree, preferably in life sciences, with 15+ years of pharmaceutical, clinical drug development, and/or medical field experience

• Significant experience in Clinical Development, Clinical Science, clinical drug development, or a related function within the pharmaceutical or biotechnology industry, with substantial responsibility in early-phase development.
• Demonstrated leadership of first-in-human and early-phase oncology studies, including dose escalation, dose optimization, cohort expansion, and proof-of-concept planning.
• Deep understanding of oncology disease biology, novel mechanisms and modalities, translational medicine, biomarker-driven development, PK/PD, and safety and tolerability assessment.
• Strong understanding of clinical trial design, clinical development strategy, clinical data review, and interpretation of oncology data.
• Experience contributing to protocols, regulatory submissions, safety reviews, health authority interactions, governance discussions, and cross-program planning.
• Experience working effectively within cross-functional teams in a matrixed environment.
• Demonstrated ability to integrate information across studies and programs to support scientific and business decision-making.
• Excellent communication, influence, and executive presentation skills.
• Demonstrated people leadership experience, including management, coaching, and development of scientific staff.

Travel 0-15%

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This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. 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.