Be a subject matter expert for the relevant disease area(s) Be the strategic leader providing a strong, clear voice for the clinical program Develop creative but realistic approaches to drug development and lead clinical efforts towards global regulatory approvals Oversight of trial conduct and safety Collaborate closely with Preclinical, Regulatory Affairs and Medical Affairs to ensure tight strategic integration of product development plans. Be accountable via Clinical Research and Operations for all relevant timelines and deliverables. Supervise closely all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials. Be responsible for final review and sign off with respect to all controlled documents including protocols, investigator brochures, and informed consent forms. Influence internal and external audiences in a high impact, highly visible fashion A highly driven, dynamic, engaged and accomplished physician-scientist with experience and insight will thrive in this role. MD with strong research background or MD PhD with best of class clinical and/or research training as shown through research support and peer-reviewed publications. Board Certification (or equivalent) or specialist training in neurology is desirable 3+ years industry experience or equivalent clinical academic research experience Sound scientific and clinical judgment Familiarity with concepts of clinical research and clinical trials, including biostatistics, and regulatory agency organization, guidelines, and practices Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication History of critical thinking and problem solving while exhibiting superior judgment and a balanced, realistic understanding of issues Outstanding leadership and collaboration skills working within a matrix environment Thrives in highly entrepreneurial biotech environment and embraces Alnylam's culture of science, passion and urgency.
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