Senior Director, Head of PV Science

About the role

Alnylam is the industry leader in the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to address the unmet needs of patients with debilitating diseases. Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality and is now advancing a robust pipeline of investigational RNAi therapeutic medicines, including multiple programs in late-stage development. The Senior Director of PV Science and Aggregate Reports is leading the PV Science department that includes all Alnylam PV Scientists and PV Fellows, and also the team of Aggregate reports specialists. In partnership with Head of Medical Safety and Risk Management (MSRM), the Senior Director will provide strategic leadership in development and management of safety profiles at all stages of the lifecycle for all Alnylam products, and will have accountability on Alnylam safety aggregate reports for submission to regulatory authorities, including, among others, Periodic Safety Update Reports, Developmental Safety Update Reports, and Risk Management Plans.

Responsibilities

• Manage teams of PV Scientists and Fellows, as well as the Aggregate report specialists
• Responsible for operationalizing PV Science department to provide continuous support in development, implementation and maintenance of a risk management system for detection, assessment and minimization of risk for investigational and marketed products
• Work closely with the Head of MSRM and safety leads analyzing MSRM team’s needs and potential process improvements in all functions, including routine and ad-hoc signaling activities, clinical trial initiations, regulatory interactions, and aggregate reports production
• Collaborate proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problem solving
• Implement and monitor process enhancements and improvements
• Manage participation of PV Scientists in Investigator meetings and Site Initiation meetings, ensuring effectiveness of the content delivery
• In partnership with Head of MSRM, provide scenario planning, strategy analysis, portfolio prioritisation, budget management and forecasting
• Responsible for ensuring the team can anticipate, develop and support improved/consistent scientific ways of working to implement effective Patient Safety and Risk Management