Director, Clinical Research-Neurology/Neuromuscular

Role Summary

Director, Clinical Research-Neurology/Neuromuscular. This hybrid role is based in Cambridge, MA (East Coast preferred). The role provides clinical leadership in developing RNAi therapeutics within Alnylam’s neuromuscular program and leads the clinical development strategy, trials, and collaboration with cross-functional teams and external experts.

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.