Clinical Science Lead
takedaEast Boston (MA)
About the role
Overview:
In this Director-level role you will shape scientific and operational strategy for clinical studies across a diverse evidence portfolio. You will drive Phase 3B/Phase 4 interventional and non-interventional studies, real-world evidence initiatives, and collaborative research to deliver robust, compliant studies that support organizational goals. You will promote digital and AI-enabled approaches to planning, oversight, analytics, and decision-making, collaborating across functions to enable evidence-based decisions.
Responsibilities:
Provide scientific and operational leadership for planning, implementation, oversight, execution, and reporting of clinical and real-world evidence studies Lead study design and document development including protocols, amendments, and related materials Ensure study quality and feasibility by aligning designs with priorities and stakeholder needs Manage study delivery by monitoring timelines, enrollment, budgets, risks, and quality metrics Interpret and translate clinical findings into reports, publications, and decision-support materials Partner with cross-functional teams for compliant governance, vendor oversight, contracting, reporting, and archiving Lead vendor and external partnership management with budget stewardship Promote continuous improvement and AI-enabled tools to enhance evidence generation and study management
Key requirements:
Advanced degree in a scientific, clinical, epidemiologic, quantitative, or health-related discipline 10+ years in clinical development, evidence generation, clinical research, or related interventional/non-interventional studies Significant experience in clinical science, development, epidemiology, real-world evidence, or related biopharmaceutical functions Strong experience authoring, reviewing, and approving clinical trial protocols and documentation Experience leading global or multi-country clinical studies through implementation and publication Extensive knowledge of study designs, GCP, regulations, ethics, quality standards, and SOP-driven practices Ability to interpret complex clinical and safety data and communicate findings to diverse audiences Strong program leadership, stakeholder management, vendor oversight, decision-making, and team leadership, including use of digital/AI-enabled tools in regulated environments leadership stakeholder management communication clinical trial protocol development real-world evidence methodologies epidemiology
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