Manager, Clinical Drug Supply

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 available drug supply for ongoing studies:
  • Label coordination with CMOs
  • Distribution timeline and coordination of product shipment with vendors and PCYC Logistics
  • Batch Record Review and coordination of QP release
• Manage temperature excursions to resolution
• Manage supply inventory for global studies:
  • Control site supply in partnership with the Clinical Operations team to address any supply issues thereby ensuring no interruptions to the progress of studies
  • Manage IP distribution settings in IRT to ensure adequate and timely supply to clinical sites.
• Solicit, review, and manage CMO quotations and work orders / initiate purchase orders for work to be completed / review and approve vendor invoices
• 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 and at Clinical Study Team (SMT) meetings.

Qualifications:

• Minimum of 5 years' experience in Pharmaceutical GMP clinical supply chain, Operations
• 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 and IRT systems

Education Requirements (degree, certifications, etc.):

Bachelor's degree in biological sciences

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Equal Opportunity Employer Minorities/Women/Veterans/Disabled