Sr. Manager, Medical Research

Alnylam Pharmaceuticals•Cambridge, MA

22h•Hybrid

About The Position

Medical Research designs and drives the operational strategy of medical affairs studies in order to generate robust real-world evidence that provides further insight on disease diagnosis and utilization, safety and clinical effectiveness of approved treatments. The Senior Manager, Medical Research plays a key role in driving the generation of high‑quality real‑world evidence to support the clinical and scientific value of Alnylam’s therapies. This role provides strategic and operational leadership for global, regional and local medical affairs research initiatives, including observational studies, collaborative research, Phase IV studies, and registries. The Senior Manager serves as a central point of coordination across cross‑functional teams and external partners, ensuring rigorous execution, inspection readiness, and compliance with global regulatory and quality standards. The role collaborates closely with Medical Affairs, HEOR, Regulatory, Safety, Legal, QA, and external investigators, vendors, and CROs to deliver impactful evidence aligned with business and scientific objectives.

Requirements

BA/BS in life sciences or related field required; advanced degree preferred.
Proven experience in pharmaceutical/biotech industry, prior experience in Clinical Operations and/or Medical Affairs managing GCP/GPP studies.
Strong knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes
Experience managing CROs and vendors across multiple studies and geographies
Must be able to actively manage and track many complex projects in parallel, managing the actions of many people toward shared outcomes
Excellent communication skills and relationship building capabilities
Strong team player that has a customer service approach and is solution oriented
Attention to detail and the ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors
Clear alignment with Alnylam Core Values

Responsibilities

Lead operational planning, execution, and oversight of medical affairs research initiatives including Alnylam‑sponsored studies and collaborative research initiatives
Provide oversight and strategic direction to CROs and vendors, to ensure performance, quality, and budget adherence
Work, either directly with the CRO, or as part of the internal team to contribute to the development of program-specific plans and study documents, e.g. protocol, informed consent forms, training materials, CRFs, manuals.
Review and maintain study specific plans generated by CRO
Ensure inspection readiness and compliance with applicable ICH/GPP standards, internal SOPs, and global regulatory requirements
Partner closely with QA, GPSRM, Legal, and Compliance to support audits, inspections, and continuous process improvement
Provide organizational and project support by working directly with cross-functional individuals and teams to coordinate and execute activities related to key medical affairs studies
Coordinate development of agendas and maintain oversight of action items from program team (internal) and vendor meetings to drive execution of key initiatives and facilitate decision-making
Management of study budgets, including annual budget planning