RNAi Clinical Research Lead - Rare Disease Programs

Alnylam Pharmaceuticals; Cambridge (MA); Hybrid; USD 255,000 - 345,000; Full time

Job summary

Alnylam Pharmaceuticals seeks an imaginative physician drug developer to lead the clinical program for RNAi therapeutics. You will guide trial design, safety oversight, and regulatory strategy across an expanding portfolio, reporting to the program medical lead in a matrix organization.

The role emphasizes strategic leadership, collaboration with Regulatory, Preclinical, Medical Affairs, and external experts, and interaction with external meetings and regulatory bodies.

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) in cardiology or specialist training
• Expertise in heart failure and/or amyloidosis is desirable
• 3+ years industry experience or equivalent clinical academic experience
• Strong clinical and scientific judgment in design of clinical research and regulatory processes
• Ability to present ideas clearly in writing and orally
• Experience in biotech/pharma collaborations and matrix environments

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 decisions with clinical impact
• Collaborate with Preclinical, Regulatory Affairs and Medical Affairs for integrated development plans
• Be accountable for timelines and deliverables in Clinical Research and Operations
• Supervise major written deliverables and presentation materials
• Final review of protocols, investigator brochures, and informed consent forms
• Influence internal and external audiences in a high visibility role

Skills

Clinical leadership

Regulatory strategy

Trial design

Biostatistics

Cross-functional collaboration

Education

MD/MD-PhD with clinical/research

Board Certification in Cardiology

Tools

Regulatory affairs

Clinical operations

Job description

Alnylam Pharmaceuticals seeks an imaginative physician drug developer to lead the clinical program for RNAi therapeutics. You will guide trial design, safety oversight, and regulatory strategy across an expanding portfolio, reporting to the program medical lead in a matrix organization.

The role emphasizes strategic leadership, collaboration with Regulatory, Preclinical, Medical Affairs, and external experts, and interaction with external meetings and regulatory bodies.