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. About Alnylam
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.
Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.
Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law. Alnylam is an E-Verify employer.
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