Director, Clinical Research-Cardiology

Role Summary

The Director, Clinical Research will serve as a clinical lead in a cardiology and/or cardiometabolic clinical development program, reporting to the program medical lead. They will influence overall clinical development strategies, drive progress and operational excellence for associated trials, and advise on the clinical development feasibility of novel targets and proof-of-concept study designs. This role involves collaboration with external experts and cross-functional teams in a matrix organization to ensure integrated development plans, and will serve as a key development spokesperson at external meetings. This is a hybrid role with two onsite days per week in Cambridge, MA or Philadelphia, PA.

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
• 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 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 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 cardiology or metabolic disease is desirable
• 3+ years industry experience or equivalent clinical academic experience
• Sound scientific and clinical judgment
• 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
• 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 partner(s)
• Thrives in highly entrepreneurial biotech environment and embraces Alnylam’s culture of science, passion and urgency