Senior Vice President of Global Patient Safety and Risk Management

il y a 2 semaines

Paris, Île-de-France Alnylam Pharmaceuticals Inc. Temps plein
Job Title: Senior Vice President of Global Patient Safety and Risk Management

Alnylam Pharmaceuticals Inc. is seeking a highly experienced and skilled Senior Vice President of Global Patient Safety and Risk Management to lead our Drug Safety/Risk Management/Pharmacovigilance function. As a key member of our R&D team, you will be responsible for developing and implementing strategies to ensure the safety of our products and compliance with regulatory requirements.

Key Responsibilities:
  • Develop and implement a next-generation vision for Global Patient Safety and Risk Management
  • Grow, direct, and support the operations of a global function supporting products from initial IND/CTA, through NDA/MAA filings, to approval and post-marketing
  • Develop a platform-wide view of safety with the ability to integrate safety across disparate products that share common chemistries
  • Ensure all relevant SOPs and systems/processes are in place making for an efficient and compliant organization
  • Develop creative but realistic approaches to drug safety and lead efforts to secure global regulatory approvals
  • Provide strategic consultation and guidance on all decisions that have significant drug safety implications
  • Supervise closely major written deliverables (all regulatory submissions [NDA/MAA safety sections and CCDS/RMP, PSUR, DSUR, PBRER], original articles, abstracts), and presentation materials
  • Be responsible for final review and sign-off with respect to all controlled documents
  • Be accountable for all relevant timelines and deliverables
  • Influence internal and external audiences in a high-impact, highly visible fashion
  • Be the lead alliance partner on all aspects of drug safety
  • Ability to build and lead a drug safety team to support the current and future Alnylam pipeline and product launches
Qualifications:
  • MD, PhD or equivalent
  • 10+ years of industry experience
  • Experience working in a fast-paced environment and building and growing teams
  • Direct knowledge and experience of major filings such as IND, CTA, NDA, and MAAs
  • Experience in developing systems and processes for handling, processing, analysis, and regulatory reporting of adverse event reports, including serious adverse events
  • Managing all aspects of post-marketing product safety in US, EU, and other major territories
  • Has managed drug safety through all Phases of drug development from pre-IND to Phase 4, and with exposure to significant drug development safety issues, including 'clinical holds' and product recalls/withdrawals, and safety-related label changes
  • Intimate up-to-date knowledge of global safety reporting requirements from a regulatory perspective
  • Proven ability and history of establishing and maintaining strong alliance relationships with biotech/pharma partners
  • Direct experience of regulatory interactions such as pre-IND, EOP2, Ad Comm meetings, and label negotiations
  • Outstanding leadership and collaboration skills working within a matrix environment
  • Comfortable working with Senior Executive Team and on occasion with Board members, and other external audiences such as KOLs, regulatory bodies, and investors
  • Thrives in a highly entrepreneurial biotech environment, with some prior experience in a small/medium-sized company an advantage

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