Senior Director, Clinical Science, Atherosclerosis
PharmaBiotechPharmacovigilanceClinical ResearchRegulatory AffairsQuality Assurancemedicalpharmacovigilancebiostatisticsregulatory submissionemacrorave
Job description
Job Description The Senior Director, Clinical Science, Atherosclerosis is responsible for providing strategic Clinical Science leadership, with accountability spanning multiple studies, programs, and assets. Reporting to the Executive Director, this role contributes to disease area strategy by applying deep therapeutic expertise to guide Clinical Science approaches, support development planning, and promote consistency in scientific standards, medical data review practices, and decision-making across the portfolio. The individual in this role is expected to bring deep knowledge of Atherosclerosis, including disease biology, current and emerging treatment landscape, relevant clinical endpoints, and key scientific considerations that influence development strategy and study design. The Senior Director partners closely with Section Heads, Asset Leads, Program Development Team Leads, and cross-functional development team members to support study planning, data interpretation, issue resolution, and broader program decisions across assigned studies and programs. This role has a strong strategic orientation and is expected to shape how Clinical Science work is performed across the Atherosclerosis 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 Disease Area and Clinical Science Strategy: Provide strategic Clinical Science leadership across the disease area, including multiple studies, programs, and assets. Contribute to disease area strategy 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, Program Development Team Leads, and cross-functional leaders to support alignment of Clinical Science activities with broader program and disease area objectives. Apply expert knowledge of therapeutic focus, disease biology, treatment landscape, and clinically meaningful endpoints to inform study planning, data interpretation, and issue resolution. Support cross-study and cross-asset integration of scientific insights to inform development decisions. Standardization and Scientific Consistency: Lead efforts to standardize Clinical Science approaches across the disease area, including medical data review practices, data interpretation principles, and key deliverables, as appropriate. Promote consistency in how Clinical Science activities are conducted across studies and programs while allowing for program-specific needs. Help establish and maintain standards, expectations, and leading practices for Clinical Science work within the portfolio. Support alignment across assets on important disease area considerations, including endpoint interpretation, patient population considerations, safety topics, and emerging scientific issues. Advocate for 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 broader understanding of trends, opportunities, risks, and program implications. Support identification and evaluation of important 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 resource for their disease area or therapeutic focus across study teams and partner functions. Portfolio and Governance Contribution: Contribute Clinical Science perspective to portfolio discussions, governance reviews, and senior leadership meetings within their disease area. Support preparation 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 development of Clinical Science talent through coaching, mentoring, feedback, and creation of development opportunities. Promote consistency in role expectations and ways of working across Clinical Scientists supporting the lung portfolio. Foster a culture of accountability, inclusion, continuous learning, and strong team 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.<
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