Senior Director, Head of PV Science

About the role

The Senior Director of PV Science and Aggregate Reports is leading the PV Science department which includes all Alnylam PV Scientists and PV Fellows, and also the team of Aggregate reports specialists. In partnership with the 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 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
• 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.
• Oversee production of Development Risk Management Plans (DRMPs). Responsible for SME contributions to initial Risk Management Plans
• Oversee production of Line Listings and their appropriate and timely submissions to required authorities
• 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
• Ability to apply business process improvement methodologies and/or developing ideas into practical business solutions
• Extensive knowledge of Argus Safety Database and Signaling tools (eg. Empirica, PV Analytics)
• Regulatory Inspection readiness experience
• Strong planning, organization, and budgeting skills
• Superb written and oral communication skills
• Adaptability and ability to approach change with positivity and foster a resilient environment
• Ability to foster collaboration within internal and external teams maintaining supportive and positive work culture
• Special Skills: Ability to represent the functional department as primary internal and external contact for services relating to PV Science department. Lead cross-functional briefings and technical meetings for project stakeholders and customer representatives. Strong negotiation skills and ability to encourage discussion and drive decisions to desired results. Strong analytic and scientific data interpretation skills.
• Supervision: Individual is expected to work independently with support from management and colleagues in SRM.