Manager, Drug Supply and Study Planning

Location
San Diego, CA
Posted
Jun 12, 2018
Required Education
Bachelors Degree
Position Type
Full time

MEI Pharma is a San Diego-based oncology company focused on the clinical development of novel therapies for cancer. Our portfolio of drug candidates includes Pracinostat, an oral HDAC inhibitor that is being developed in combination with azacitidine for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Our clinical development pipeline also includes ME-401, a highly selective, oral PI3K delta inhibitor, voruciclib, an oral, selective CDK inhibitor, and ME-344, a novel mitochondrial inhibitor.  MEI currently has an open position for a Manager, Drug Supply and Study Planning in our Clinical Operations Department.            

Job Summary:

With experience in the pharmaceutical or biotech industry, the Manager, Drug Supply and Study Planning, has oversight of clinical supply chain logistics and study timeline planning for MEI’s drug development studies. The ideal candidate will have a background specific to pharmaceutical or biotechnology products, and the unique supply chain challenges present in a GMP environment.

Management Scope:  None at this time.

Responsibilities & Duties:

Clinical Supply

  • Support clinical study teams with study drug supply demand, forecasting, and logistical planning for all clinical trials
  • Manage vendors, including managing quotes, purchase orders, invoicing and forecasting and demand planning 
  • Support project total drug supply forecasting activities, including lot allocation activities
  • Work closely with CMC and Quality groups for production input into the supply chain, as well as to ensure release of product domestically and internationally
  • Provide expertise with packaging technologies
  • Provide input to the development of IP-related study documents including protocols, study and pharmacy manuals
  • Work with Quality Assurance to review and resolve all shipment issues (damage, temperature excursions, non-compliance).  Analyze root cause and design solutions to resolve recurring problems, including deviation and CAPA ownership.
  • Creatively seek out ways to improve supply chain processes.

Study Timeline Planning

  • Work closely with Clinical Operations and Project Management to plan and define clinical study deliverables, timelines, assumptions, and parameters
  • Track study timelines and generate status reports to ensure alignment with study plans and timelines and overall clinical development plan
  • Support scenario planning and evaluations.

Requirements:

  • A Bachelor’s degree in the sciences is preferred
  • Minimum of 5 years of planning experience in clinical supply chains in biotech/pharmaceutical industry
  • Minimum of 2 years of experience of clinical study timeline planning preferred
  • Global release and distribution logistics experience is required
  • Working knowledge of GMP and pharma industry procedures and regulations
  • Theoretical and practical knowledge of clinical supply forecasting and demand planning
  • Must possess import/export expertise including customs, transportation, and regulatory guidelines.
  • Ability to anticipate/define problems, collect and analyze data, make recommendations, and execute corrective actions and preventative measures
  • Strong interpersonal skills and the ability to work independently, as well as a member of a team
  • Must have exceptional verbal, written, presentation, communication and negotiation skills
  • Proficiency with: Microsoft Word/Excel/PowerPoint/Project software
  • Only San Diego candidates considered.

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
  • Regular communication (hearing/speaking).
  • Routine office duties including computer keyboard use and some lifting of light-weight office equipment and files as needed.
  • Vision requirements include: close vision and ability to focus.
  • Noise conditions range from quiet to moderate.