Senior Director, Head of PV Science
alnylampharmaceuticals
2 months ago
Full-time
On-site
Cambridge, MA or Philadelphia, PA
$245,500 - $332,100 USD yearly
Leadership
Moneyboard classification: Published range reaches threshold
Reported USD annual base: $245,500–$332,100
Original source: Greenhouse
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 onsite 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 and audits
Qualifications
Master’s or doctoral degree in a medical, healthcare-related, or relevant scientific discipline (e.g., MD, PharmD, RN)
At least 12 years of pharmaceutical industry experience, including 8 years in drug safety/pharmacovigilance and 5 years leading teams; global experience in RNAi therapeutics and rare diseases is preferred
Demonstrated leadership and team-building skills, with a track record of building and expanding teams
Extensive pharmacovigilance expertise and advanced knowledge of global regulatory requirements, including those in the US, EU, LATAM, and APAC, as well as device safety regulations
Extensive knowledge of safety operations, including case processing and aggregate report production
Ability to succeed in a matrixed environment while modeling company leadership commitments and values; experience working across diverse geographies, business settings, and cultures is strongly preferred
Ability to apply process-improvement methodologies and translate ideas into practical business solutions
Extensive knowledge of the Argus Safety Database and signal detection tools, such as Empirica and PV Analytics
Experience preparing for regulatory inspections
Strong planning, organizational, and budgeting skills
Excellent writ
Reported USD annual base: $245,500–$332,100
Original source: Greenhouse
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 onsite 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 and audits
Qualifications
Master’s or doctoral degree in a medical, healthcare-related, or relevant scientific discipline (e.g., MD, PharmD, RN)
At least 12 years of pharmaceutical industry experience, including 8 years in drug safety/pharmacovigilance and 5 years leading teams; global experience in RNAi therapeutics and rare diseases is preferred
Demonstrated leadership and team-building skills, with a track record of building and expanding teams
Extensive pharmacovigilance expertise and advanced knowledge of global regulatory requirements, including those in the US, EU, LATAM, and APAC, as well as device safety regulations
Extensive knowledge of safety operations, including case processing and aggregate report production
Ability to succeed in a matrixed environment while modeling company leadership commitments and values; experience working across diverse geographies, business settings, and cultures is strongly preferred
Ability to apply process-improvement methodologies and translate ideas into practical business solutions
Extensive knowledge of the Argus Safety Database and signal detection tools, such as Empirica and PV Analytics
Experience preparing for regulatory inspections
Strong planning, organizational, and budgeting skills
Excellent writ