Associate Director, Clinical Supply Chain

Alnylam Pharmaceuticals, Inc. Cambridge , MA 02138

Posted 2 months ago

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. 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


  • B.Sc. in a scientificfield
  • 15 years of direct

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.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director Clinical Supply Chain

Agios Pharmaceuticals

Posted 3 months ago

VIEW JOBS 2/17/2019 12:00:00 AM 2019-05-18T00:00 Associate Director, Clinical Supply Chain Agios Pharmaceuticals ( in Cambridge, Massachusetts, is the first biopharmaceutical company dedicated to drug discovery based on targeting cancer metabolism, which offers the potential for a new class of oncology therapeutics targeting metabolic pathways critical to cancer cell growth, proliferation and survival. Since 2008, Agios has built a portfolio of first-in-class cancer metabolism programs, and has established industry-leading core competencies for studying dysregulated metabolism in cancer; these capabilities are extended to other therapeutic areas, such as inborn metabolic diseases, as well. The Supply Chain group at Agios Pharmaceuticals is building a new generation of pharmaceutical development capabilities to deliver transformative precision medicine with quality and speed. It is geared towards utilizing industry expertise and cutting edge technology to support full speed development activities. We are seeking a motivated and experienced Associate Director, Clinical Supply Chain within the Supply Chain organization at Agios. A successful candidate needs to demonstrate leadership ability, end-to-end clinical supply chain expertise (managing all aspects of clinical supplies in a global trial setting) and be able to work independently in a fast paced and rapidly evolving organization. Job Responsibilities: * Lead the Clinical Supply Chain organization on both the program and protocol levels, assuring supply milestones are met across all development programs. This includes responsibility for Phase I-III clinical trials, Investigator Sponsored Trials and Managed Access Programs. * Execute Clinical Supply Chain activities including demand forecasting, trial monitoring & resupply planning, label design, packaging vendor management activities, IRT set-up and distribution activities. * Accountable for contract vendor oversight which includes clinical packaging, labeling and distribution. * Responsible for representing assigned programs / protocols in Clinical Supply Planning (CSP) review meetings, addresses and mitigates program risks, and reviews current state of each assigned protocol within the development program to ensure uninterrupted supply. * Will support the department budget including review & approval of vendor invoices and monitoring planned vs. actual spend on both an assigned program and trial levels. * Develop root cause analysis and/or risk mitigation strategies and action plans to address any potential issues that may impact the integrity of the Clinical Supply Chain. * Will identify and execute on Continuous Improvement initiatives within the Clinical Supply Chain organization to improve processes, accelerate speed to customer, and reduce supply chain risks. Minimum Qualifications: * B.S in pharmaceutics, chemistry, biology, material science, chemical engineer or related disciplines with 10+ years of hands on clinical supply chain experience in the pharmaceutical industry * Expertise and experience with packaging & labeling for Phase III double-blind, randomized, placebo-controlled trials Preferred Qualifications: * Excellent project management and communication skills * Experience managing / interacting with CROs and CMOs * Experience working with Investigator Sponsored Trials (IST's), and Single Subject IND / Named Patient requests * Highly organized and detail oriented * Experience working with SmartSupplies Forecasting and Bracket PMD (Planning, Materials & Distribution) software as well as various IRT systems / vendors * Ability to navigate and be successful in a fast-paced, highly-matrixed work environment * Experience with clinical label design & vendor management activities * A desire to be part of a highly innovative company with the focus on helping patients Agios Competencies: * Drives and Delivers : Executes and Operates to a High Standard and Resourceful * Connect and Relate : Collaborates and Talks Straight * Build and Transform : Improves Continuously and Builds Networks * Lead from Every Chairs : Empowers Self and Others and Challenges Self and Others Agios Pharmaceuticals Cambridge MA

Associate Director, Clinical Supply Chain

Alnylam Pharmaceuticals, Inc.