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Senior Director, Clinical Supply Chain

Company: Epizyme
Location: Cambridge
Posted on: January 12, 2021

Job Description:

Pharmaceutical Sciences Cambridge, Massachusetts DescriptionEpizyme, 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 .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 Responsibilities

  • The 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 trials
  • Work 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 solutions
  • Develop 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 improvements
  • Integrate 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 industry
    • MBA 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 change
    • Excellent analytical skills to evaluate and interpret moderately complex situations/problems using multiple sources of information
    • Demonstrated ability to work independently & lead teams
    • Demonstrated program & project management skills
    • MBA or equivalent Degree, Science background and education a plus.
    • Understands advanced supply chain concepts
    • Experience with industry regulations, GMP, compliance and pharmaceutical and/or biotechnology processes
    • Possess excellent organizational and communication skills
    • Advanced knowledge of Microsoft Office, Oracle Cloud a plusEpizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace. You have been redirected to a Epizyme job page

Keywords: Epizyme, Cambridge , Senior Director, Clinical Supply Chain, Executive , Cambridge, Massachusetts

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