Head of Medical Safety & Risk Management

Alnylam Pharmaceuticals, Inc.; Cambridge (MA); On-site; USD 180,000 - 250,000; Full time

Job summary

Alnylam Pharmaceuticals in Cambridge, MA seeks a seasoned Director of Medical Safety and Risk Management to lead the safety profile across product lifecycles. You will guide trial safety design, endpoints, and data interpretation while coordinating with clinical, regulatory, and commercial teams.

The role demands strong medical judgment, proactive pharmacovigilance expertise, and an ability to drive safety deliverables within tight timelines.

Qualifications

• Medical Degree with a minimum of 3 years of medical practice is required.
• Sound clinical acumen and a wide range of therapeutic area knowledge.
• Pharmaceutical industry experience in pharmacovigilance and/or clinical research/development is preferred.
• Experience in clinical development is a plus.
• Knowledge of clinical research methodology, epidemiology/biostatistics, pharmacovigilance tools and processes and regulatory framework.
• Ability to synthesize and analyze safety data from various sources; problem-solving in a complex environment.
• Strong written and spoken communications skills, with medical/scientific writing experience preferred.
• Excellent networking and relationship-building skills for cross-functional collaboration.
• Expertise in international regulations governing drug safety and audits; FDA/EU/ICH familiarity preferred.
• Interpersonal and decision-making skills; ability to gain credibility across teams.
• Ability to work in fast-paced environments with tight timelines.

Responsibilities

• Lead development and maintenance of safety profile across product lifecycle.
• Oversee active safety monitoring and signal detection for defined portfolio.
• Advise clinical development teams on trial safety design and endpoints.
• Ensure timely delivery of safety deliverables for regulatory documents.
• Lead cross-functional Safety Risk Management Teams and elevate safety issues.
• Provide strategic safety input to internal and external stakeholders, including regulators.
• Author safety documents (DSUR, PSUR, RMPs) and safety communications.
• Collaborate with partners to harmonize safety identification and communication.

Skills

Medical degree

Clinical pharmacovigilance

Regulatory knowledge

Safety data analysis

Leadership

Education

Medical Degree

Job description

Alnylam Pharmaceuticals in Cambridge, MA seeks a seasoned Director of Medical Safety and Risk Management to lead the safety profile across product lifecycles. You will guide trial safety design, endpoints, and data interpretation while coordinating with clinical, regulatory, and commercial teams.

The role demands strong medical judgment, proactive pharmacovigilance expertise, and an ability to drive safety deliverables within tight timelines.