Job Description - SVP, Global Patient Safety & Risk Management (230666)
Overview The Senior Vice President of Global Patient Safety & Risk Management will be responsible for leading and scaling a Drug Safety/Risk Management/Pharmacovigilance function commensurate with company P^5x25 goals and strategic priorities. The Senior Vice President GPSRM role reports directly to the Chief Development Officer, reflecting our regard for the centrality of drug safety in all that we do. The successful applicant will have the ability to develop strategy and grow the Drug Safety Expertise Area, while remaining very hands-on like smaller biotech culture. He/she will be a key member of the R&D team and work in a vibrant culture, thriving on science, passion, and urgency.
Key Responsibilities Be the senior strategic and operational leader providing a strong, clear voice for the drug safety program and have a clear 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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