Pharmacyclics, LLC

Senior Manager, Clinical Drug Supply

Location
Sunnyvale, CA
Posted
May 15, 2018
Ref
2384
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.

General Position Summary:

  • Manage global clinical drug supply activities to ensure investigational product availability for ongoing clinical trials:
  • Manage study label coordination with CMOs
  • Manage the distribution timeline and coordinate global product shipments in collaboration with transportation vendors and PCYC Logistics
  • Track distribution of depot and site supply and reconciliation of returns and product destruction
  • Team with preferred vendors for sourcing of comparator products and required documentation to ensure products are received, labeled/packaged and distributed for on-time study starts and per the manufacturing plan
  • Perform Batch Record Review and coordinate QP release
  • Manage supply inventory for global studies:
  • Manage site supply by partnering with the Clinical Operations team and address any supply issues ensuring no interruptions to the progress of studies
  • Perform supply and inventory reviews as required per study.
  • Perform IRT review of the drug supply section at study start up and perform UAT testing. Perform evaluations of IRT settings to ensure accurate drug supply distribution for the study. Utilize IRT system for daily study support activities
  • Manage the demand forecasting as part of the planning cycle and lead communication with CMO:
  • Review updates received from Clinical Operations and translate into demand forecasting. Manage active enrollment data for ongoing studies per IRT and update demand forecasts
  • Adjust supply plans for ongoing studies per defined guidelines
  • Lead the management and supply requirements discussion with assigned CMO
  • Additional responsibilities:
  • Review SOPs and guidance documents and provide feedback to support revisions
  • Solicit, review, and manage CMO quotations and work orders / initiate purchase orders for work to be completed / review and approve vendor invoices
  • Represent Clinical Supply at Clinical Study Team (SMT) meetings
  • Qualifications:

      Requires 5-10 years experience in Pharmaceutical GMP clinical supply chain, Operations, or program management
    • Understanding of cGMP's and pharmaceutical industry procedures and regulations
    • Ability to plan, budget and organize.
    • Strong, open and transparent communication skills (verbal and written)
    • Strong organizational and time management skills
    • Strong Project management skills and computer proficiency
    • Experience with : MS Excel, Word, MS Project, MS Powerpoint
    Education Requirements (degree, certifications, etc.):

    • Bachelor's degree in biological sciences preferred

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