Director, Clinical Research-Neurology/Neuromuscular

Role Summary

Director of Clinical Research – Neurology/Neuromuscular leading clinical development programs in RNAi therapeutics. Provides clinical leadership in neuromuscular-focused programs, influencing overall development strategy and driving progress and operational excellence for associated trials. Works across cross-functional teams in a matrix organization and represents development externally at regulatory and scientific meetings. Hybrid role based in Cambridge, MA (East Coast-based talent preferred).

Responsibilities

• 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 to secure global regulatory approvals.
• Oversee 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 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.

Qualifications

• MD with outstanding research background or MD PhD with outstanding 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 experience
• Sub-specialty experience or training in neuromuscular is preferred
• Sound scientific and clinical judgment; history of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
• Familiarity with concepts of clinical research and clinical trial design, 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
• Outstanding leadership and collaboration skills working within a matrix environment
• Experience with and knowledge of working with biotech/pharma partner(s)
• Thrives in highly entrepreneurial biotech environments and embraces Alnylam’s culture of science, passion and urgency