Senior Director, Head of PV Science

Overview

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.

*This is a hybrid role with on site presence required 2 days a week in either our Cambridge (preferred) or Philadelphia offices. 

Summary of Key Responsibilities for PV Science

• 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 processes. Lead development of relevant SOPs, work practices and training activities
• Participate in audits, inspections and quality improvement initiatives. Proactively manage process improvements and collaborate with Global Safety Operation team and other functions to address relevant corrective actions
• Oversee activities related to the functioning of Alnylam safety committees, including but not limited to, SRMT, SRMT Chairs and ESB meetings
• Provide direction on relevant meeting material preparation
• Ensure timely completion of all action items
• Participate in relevant safety discussions providing scientific and operational contributions
• Responsible for signal detection through global medical Literature monitoring
• Oversee creation of Development Risk Management Plans (DRMPs). Responsible for SME contributions to initial Risk Management Plans
• Lead the cross-functional collaboration between SRM, Regulatory Affairs, Medical Writing, Medical Affairs, and other functions for all activities related to regular updates of Risk Management Plans for approved products.

Summary of Key Responsibilities for Aggregate Safety Reports

• In agreement with the Head of SRM and the Head of MSRM, assess strategic options to ensure Alnylam readiness for aggregate reports production, including insourcing vs outsourcing, AI capabilities build, geographical footprint
• Oversee planning, production and successful submission of DSURs for all Alnylam products in development. In collaboration with required stakeholders, responsible for Health Authorities’ communications in relation to DSURs  
• Responsible for planning, production, and successful submission of PSURs. In close collaboration with safety physicians and other contributing functions, oversee the authoring of the report, including strategy of the safety analysis. In collaboration with required stakeholders, responsible for Health Authorities’ communications in relation to PSURs.
• Oversee production of Line Listings and their appropriate and timely submissions to required authorities
• Serve as an SME for Aggregate Reports during inspections