Clinical Supply Chain, Associate Director
Alnylam was founded in 2002 on arevolutionary vision and bold mission which remain firmly in place today. Weare leading the translation of RNA interference (RNAi) into a new class ofinnovative medicines with the potential to transform the lives of people withrare genetic, cardio-metabolic, hepatic infectious, and central nervous systemdiseases with unmet need. Our first medicine, the first-ever RNAi therapeutic,has recently been approved by the FDA in the US for the treatment of thepolyneuropathy of hereditary transthyretin-mediated amyloidosis in adults andby the European Medicines Agency in the EU for the treatment of hATTRamyloidosis in adults with stage 1 or stage 2 polyneuropathy. In addition,Alnylam has four investigational medicines in late-stage development. www.alnylam.com. Alnylam is proud to have beenrecognized as one of The Boston Globe's Top Places to Work in 2015, 2016, 2017and 2018- four years in a row!
Clinical Supply Chain, Associate Director is responsible for ClinicalProgram(s) ranging from Phase 1 4, as assigned, in support of ClinicalDevelopment pipeline. Primary focus ofthis role includes oversight of suppliers, software systems, and enhancement ofForecasting and planning tools, inventory management system, InteractiveResponse Technology Systems (IRT) to support growing pipeline. Strong knowledge of forecasting and planningsoftware systems is a must. Scope ofactivities includes finished goods production, inventory management, logistics(bulk and site shipments both manual and/or IRT), drug return, reconciliation,and program closeout. Cross-functional collaboration with partners on teamsincluding Quality Assurance, Clinical Operations, Regulatory Affairs, CMC,Suppliers (CMO/IRT/CRO), Global Planning, and Project Management. The clinical supplies manager will work withcross-functional team to ensure supply of IMP, Placebo, Comparators, Standardof Care, and/or Ancillary Supplies to clinical sites globally for assignedprotocols and programs.
Sense of urgency in fast-paced environment, prioritizing patients' needsis essential. Good communication skillsare required with internal and external customers, and suppliers, in order toaccomplish program objective, and patient needs. He/She manages supply plan,inventory management, production, distribution, returns & destruction. Clinical Supplies documentation associatedwith assigned program, contract management of program(s), and invoiceprocessing with suppliers, documentation supporting GMP activities. The Associate Director, Clinical Supply Chainis responsible to monitor inventory levels, mitigate any identified risks toprogram and patients, and provide feedback to Clinical Operations and theirdirect Manager regarding inventory health supporting on-going programs, expiryand re-supply. It is the responsibilityof the Associate Director to ensure all program goals and objectives are ontime, and in full (e.g. FPI, SIV dates, IRT Go LIVE dates, re-supply, no misseddoses to patients). Participates in Clinical Supplies team developmentalinitiatives, as assigned and needed. Update Inventory management systems monthly, and generation of monthlydashboard for assigned program(s), and support Supplier Relationship Management(CMO, IRT, CRO) as needed.
Summary of Key Responsibilities
Work actively and align with Clinical Operation/Study team to helpcreate forecast for assigned study and program including enrollment rate.
Develop and implement a qualification/validated software solutiontechnology for forecasting and planning of Clinical Supply Chain pipeline.
Support country logistics for shipping and importation, on assignedstudy or program.
Oversight of key suppliers, adopting Supplier RelationshipManagement tools (SRM) to key suppliers and compliance statndards insupplier selection.
Help develop an Inventory strategy for assigned program, study andregion.
Monitor regularly drug expiry and the appropriate inventoryre-supply for assigned clinical programs.
Manage packaging requirements for programs and/or protocolsassigned
Monitoring of enrollment, drop-out rates and actual supply need onassigned protocols and/or programs. Ensure continuous re-assessment ofProject needs, on assigned programs and/or protocols.
Drive label creation and approvals process, including translationsfor all countries, on assigned study and/or program responsible for.
Support a vendor management process including RFP, and SOWs withvendors, on assigned clinical study.
Support of regulatory filings including IND submission information.
Manage return and destruction of IMPs from sites to depots forassigned study.
Interface with othermembers of the Clinical Supply Chain to provide and obtain information and toensure on time delivery of assigned study.
Perform inventorychecks and manage inventory levels and cycle count at the vendor yearly onassigned study.
Manage temperature excursionsduring transportation on assigned study
Clinical Supply Chain experience
Experience in ClinicalSupply and Pharmaceutical Development required, along with strong understandingof GMP and GCP
Strong expertise inexcel, and IT solutions for inventory management, forecasting, planning, andsimulation
Knowledge ofImport/export regulations, including pro-forma invoice generation, importregulations, and global trade compliance.
Experienced workingwith third-party CMO clinical supply operations.
Oversight of Suppliersusing SRM tools
Alnylam Pharmaceuticals is an EEO employer committed to anexciting, diverse, and enriching work environment.
Alnylam Pharmaceuticals, Inc.