Director, Medical Safety & Risk Strategy

Alnylam Pharmaceuticals, Inc.; Cambridge (MA); Hybride; USD 190 000 - 290 000; Plein temps

Avantages offerts par ce poste

Hybrid work

Résumé du poste

Alnylam Pharmaceuticals in Cambridge, MA, seeks a Director, Medical Safety and Risk Management to lead the safety profile development across the product lifecycle and partner with clinical, regulatory, and commercial teams. The role requires excellent medical judgment, strong analytical skills, proactive risk management, and a hands-on leadership style in a fast-paced environment.

The position calls for strategic safety leadership, ongoing safety monitoring, guidance on safety endpoints, and

Qualifications

• Medical Degree with a minimum of 3 years of medical practice.
• 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, regulatory framework and safety processes.
• Ability to synthesize and analyze safety data from various sources.

Responsabilités

• Lead strategic development of the safety profile of assigned products.
• Oversee active monitoring and continued assessment of safety data via signal detection and literature review across product lifecycle.
• Guide clinical development teams on safety endpoints and safety data interpretation.
• Ensure timely completion of safety deliverables for CSRS, regulatory submissions and related documents.
• Lead multidisciplinary Safety Risk Management Teams on safety topics and coordinate with decision-makers.
• Serve as the safety expert for regulatory discussions with authorities and external bodies.
• Author and own safety content for DSUR, PSUR, RMPs and related communications.

Connaissances

Medical judgment

Analytical skills

Safety signal detection

Regulatory knowledge

Communication skills

Leadership

Cross-functional collaboration

Problem solving

Formation

Medical Degree

Description du poste

Alnylam Pharmaceuticals in Cambridge, MA, seeks a Director, Medical Safety and Risk Management to lead the safety profile development across the product lifecycle and partner with clinical, regulatory, and commercial teams. The role requires excellent medical judgment, strong analytical skills, proactive risk management, and a hands-on leadership style in a fast-paced environment.

The position calls for strategic safety leadership, ongoing safety monitoring, guidance on safety endpoints, and