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About the Role

The Senior Director, Clinical Science, Oncology Early Development provides strategic Clinical Science leadership for novel assets from candidate transition through first-in-human development and clinical proof-of-concept. This role shapes early development and scientific platform strategy by applying expertise in early-phase oncology, translational medicine, biomarker strategy, and first-in-human trial design to guide development plans and enable data-driven decision-making across the early oncology portfolio.

Responsibilities

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.

Requirements

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.

Skills

Clinical Development
Clinical Research
Clinical Sciences
Clinical Study Management
Clinical Trial Development
Clinical Trial Management
Clinical Trials Operations
Disease Research
Early Phase Clinical Trials
Oncology
Cross-Functional Teamwork
Decision Making
Leadership

Location

USA - New Jersey - Rahway

Work Type

Hybrid
Regular

Experience Level

Senior Director
8+ years
12+ years
15+ years

Education Level

Advanced scientific or healthcare degree (e.g., PhD, PharmD)
Master’s degree
Bachelor’s degree

Salary/Compensations

$210,400.00 - $331,100.00

Benefits

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

About the Company

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Equal Opportunity

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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