Pharmacyclics, LLC

Associate Director, Clinical Drug Supply

Location
Sunnyvale, CA, United States
Posted
Sep 13, 2018
Ref
2437
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/Purpose:

  • Direct team of clinical drug supply study leads and supply planners
  • Oversee global clinical drug supply activities associated with the team's trials (secondary packaging vendor selection, technical batch record review, QP Release coordination, clinical label design, packaging and labeling, IRT efficiencies)
  • Review and approve secondary packaging work orders and quotations
  • Coordinate and manage clinical drug demand planning activities for all existing and new clinical studies including associated budgets
  • Coordinate and manage demand and forecast of comparator products
  • Generate SOP gap assessment

Key Accountabilities/Core Job Responsibilities:

  • Provide clinical study team leadership - support
  • Direct demand forecast and planning for all PCYC clinical trials for all study drugs
  • Provide support for all clinical drug supply activities associated with team's assigned trials
  • Direct partnership with co-therapy suppliers - manage relationships as well as forecasting and demand planning
  • Ensure efficiency during regularly scheduled cross-functional supply planning meetings
  • Support departmental total drug supply forecasting activities including brite stock roll-ups and lot allocation activities

Qualifications:

  • 10+ years experience in GMP clinical supply chain, supply chain or pharmaceutical program management
  • Minimum 5 years experience personnel management
  • Ability to plan, budget and organize
  • Ability to make strategic decisions
  • Understanding of cGMP's and pharmaceutical industry procedures and regulations
  • Strong, open and transparent communication skills (verbal and written)
  • Solid organizational and time management skills
  • Project management skills and computer proficiency
  • Experience with: MS Excel, Word

Education Requirements (degree, certifications, etc.):

  • Minimum Bachelor's Degree in business or biological sciences

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