AbbVie Pharmacyclics Associate Director, Clinical Drug Supply in Sunnyvale, California

Associate Director, Clinical Drug Supply

Location: Sunnyvale, CA

# of Openings: 1

Description

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 allclinical 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

Equal Opportunity Employer Minorities/Women/Veterans/Disabled