Senior Medical Director, Clinical Research- Hepatology

Key Responsibilities

• Be the strategic leader providing a strong, clear voice for the clinical programs
• Develop creative but realistic approaches to drug development and lead clinical efforts to secure global regulatory approvals
• Oversight of trial conduct and safety
• Provide strategic consultation and guidance to Research on all decisions that have significant clinical components and implications
• Collaborate closely with Preclinical, Regulatory Affairs, Medical Affairs and Commercial to ensure tight strategic integration of product development plans
• Drive/supervise all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials
• Be responsible (as appropriate in line with SOPs) for final review and sign off with respect to all controlled documents including protocols, IBs, informed consent forms
• Influence internal and external audiences in a high impact, highly visible fashion

Qualifications

• MD with strong research background or MD PhD, with a track record of successful research support and peer review publications
• Board Certification (or equivalent) or specialist training is highly desirable; drug development experience in hepatology (autoimmune liver disease) would be a great advantage, but not essential
• 5+ years industry experience or equivalent clinical academic experience
• Sound scientific and clinical judgment
• Successful track record of leading Phase 2/3 clinical programs, including major interactions with Health Authorities
• Familiarity with concepts of clinical research and clinical trial design, including biostatistics, 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 solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
• Outstanding leadership and collaboration skills working within a matrix environment
• Experience and knowledge of working with biotech/pharma partners a plus
• Thrives in highly entrepreneurial biotech environment and embraces Alnylam’s culture of science, passion and urgency