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Job Details

Senior Director Clinical Supply Chain

Company name
Epizyme, Inc

Location
Cambridge, MA, United States

Employment Type
Full-Time

Industry
Logistics, Manager, Operations, Executive, Pharmaceutical

Posted on
Dec 21, 2020

Valid Through
Apr 05, 2021

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Profile

Epizyme, Inc. is a fully integrated commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIK™ (tazemetostat), for the treatment of patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in an ongoing confirmatory trial. The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them. For more information, visit www.epizyme.com.Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies.  Join a dynamic, diverse and fun work environment consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient.   Key ResponsibilitiesThe leader of the Clinical Supply Chain is tasked with overall management of Supply to meet program goals for our commercial product and development candidates. Candidate will be very hands on with day-to-day operations and be involved strategic decisions in clinical and overall supply chain/CMC Mfg. projects.Management responsibility for sourcing, supply and packaging of development candidates, co-therapy drugs and commercial product in support of global clinical trialsWork closely with Clinical Operations to identify study drug requirements, distribution warehouses and import/export requirements.Monitor the supply strategy of the business including forecasting and communication with suppliers.Partner with Finance on Budgets, Procurement and Accounting and work within industry standard guidance.Responsible for the accurate inventory and accounting of clinical product in the distribution network, in addition, coordinate other CTM activities, such as, expiry extensions, returns and temperature excursions.Effectively interface and coordinate activities with the broader Supply and CMC team for accurate API and drug product manufacturing requirements planning and execution.Core team member for development program CMC teams Maintain and develop key metrics to evaluate supplier performance; conduct post-contract management and facilitate supplier relationship management processes. Track supplier performance metrics, reporting and coordination of Supplier Business Reviews.Develop Strategic solutions for current and future Clinical Supply Chain needs. Including sourcing computer systems and applications that support and streamline business need.  Partnering with CMO’s and other CRO’s for best in practice solutionsDevelop direct report and help grow the line function to align with corporate goals and objectives.Identify and analyzes problems and opportunities to streamline departmental activities and lead projects to drive improvementsIntegrate all programs and projects in a compliant manner by working closely with Quality and Regulatory functions.  Education & Requirements:8-10 years of operations or supply chain experience in the bio-pharma industryMBA and Minimum of 10 years of experience in the pharmaceutical industry. BA degree in science is a plus. Travel expectation is 5-10% (depending on post-covid19 travel restrictions and health considerations)Ability to work in a fast-paced, dynamic environment and deal effectively with conflicting priorities and changeExcellent analytical skills to evaluate and interpret moderately complex situations/problems using multiple sources of informationDemonstrated ability to work independently & lead teamsDemonstrated program & project management skillsMBA or equivalent Degree, Science background and education a plus.Understands advanced supply chain conceptsExperience with industry regulations, GMP, compliance and pharmaceutical and/or biotechnology processesPossess excellent organizational and communication skillsAdvanced knowledge of Microsoft Office, Oracle Cloud a plusEpizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.

Company info

Epizyme, Inc
Website : http://www.epizyme.com/

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