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.

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
• 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
• 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
• Oversee production 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
• Serve as an SME for Aggregate Reports during inspections and audits

Qualifications

• Education: Master or doctorate degree in a medical or healthcare related discipline (MD, PharmD, RN), or relevant scientific discipline.
• Experience: A minimum of 12 years in the pharmaceutical industry with a minimum of 8 years in drug safety/pharmacovigilance. A minimum of 5 years of experience in managing teams.
• Specific experience in RNAi therapeutics and rare disease areas at a global level is an advantage.

Required Skills And Experience

• Strong leadership and team building skills with track record of team building and expansion
• Extensive knowledge of Pharmacovigilance and advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements including device safety regulations
• Extensive knowledge of safety operations, including but not limited to case processing and aggregate reports production
• Ability to work in a matrix environment in accordance with the company leadership commitments and values. Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
• Experience of working across diverse geographic areas, business settings and cultures strongly preferred
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