Senior Director of Global Patient Safety & Risk Management (GPSRM)The role of the Senior Director of Global Patient Safety & Risk Management (GPSRM) is to provide guidance, expertise, and strategic direction on all aspects of clinical safety throughout the lifecycle for multiple products/programs both in development and post marketing. This is a highly visible role that will interface across all levels and functional areas and will need to partner closely with the clinical development, regulatory, medical affairs, and commercial teams. The exceptional candidate that we seek will have a proactive and innovative approach and a flexible, hands-on nature that works with a high sense of urgency.Summary of Key ResponsibilitiesLead active monitoring and continued assessment of safety profile through systematic signal detection and critical review of aggregate safety data and literature during all phases of the life-cycle of a defined portfolio of medicinal products.Lead a multifunctional team (Safety Risk management Team) regarding safety relevant topics and escalate all safety relevant matters to the appropriate decision-making level with proposals for solutions based on analysis of the available information. Provide guidance for the development of global safety and risk management strategies for a portfolio of Alnylam products.Support the Executive Director of GPSRM in various duties including onboarding and mentoring of safety physicians, PV Scientists and GPSRM Fellows, building safety science capabilities and exploring innovation in safety science to support the unique requirements of the Alnylam portfolio,Guide the clinical development teams regarding all aspects of clinical safety, including trial design, appropriateness of safety endpoints, analysis, and interpretation of safety data. Serve as a Clinical Trial Review Board member.Be accountable for timely delivery of all safety deliverables towards Clinical Study Reports, preparations for market applications and all other regulatory documents.Serve as the safety expert providing strategic input to key stake holders in relation to product safety, understand the business strategy for the product and be knowledgeable about the (medical) context of the respective product class. Be subject matter expert for safety relevant discussions with regulatory agencies and other significant external bodies.Be the accountable content owner for all safety relevant content of relevant safety documents during clinical development (e.g. DSUR, Development Risk Management Plans, Safety Analysis Plans) and post approval (e.g. PSUR, RMPs, medical expert statements and answers to HAs requests, publications). Be content owner for safety relevant communications such as DHCP letters and company statements.Collaborate with pharmacovigilance and drug safety colleagues from licensing partners to align on a harmonized approach to identifying, evaluating and communicating safety issues.Provide guidance for the development of worldwide pharmacovigilance strategies within Alnylam's goals, including the support to Safety Operations for establishing and maintaining policies and procedures for the Clinical Drug Safety Department.QualificationsAlnylam prides itself on its entrepreneurial, fast-paced environment where success is rapidly rewarded. There is a strong pipeline, significant resources, and every intention of continuing the phenomenal rate of success and growth. This position offers an opportunity to have tremendous impact on the growth of the company. The culture values hard-work, creativity, flexibility, a sense of humour and a hands-on, problem-solving attitude.The ideal candidate will have the following mix of personal and professional characteristics:Medical Degree with previous experience in medical practice is required;Previous pharmacovigilance and/or clinical research/clinical safety/clinical development/medical affairs experience in the pharmaceutical industry.Clinical safety experience - early phase through post-marketing - including initial filing experience. Risk management experience including writing of initial and follow-up plans, strategizing on post-marketing safety studies and/or REMS programs.Experience interfacing with regulatory and health agencies on a global basis.
Experience with FDA advisory committee preparation and presentation desirable.Leadership and people management skillsSound clinical acumen and a wide range of therapeutic area knowledge.Ability to synthesize and analyze safety data from various sources. Proficiency in problem-solving within a highly complex environment.Strong communications skills, both written and spoken, ideally with demonstrable experience in medical / scientific writing.Excellent networking and relationship building skills for successful cooperation with internal and external customers.Expertise in international regulations governing drug safety.
Experience in managing compliance or audits. Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments.Knowledge of clinical research methodology, clinical epidemiology/biostatistics, pharmacovigilance tools and processes and relevant regulatory framework.Excellent interpersonal and decision-making skills. Strong influencing skills with the ability to quickly earn credibility across other functional areas.Ability to work in fast-paced environment with rapidly approaching timelines is important