Supply Chain Study Manager - Gaithersburg, MD | Biospace
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Supply Chain Study Manager

AstraZeneca Pharmaceuticals LP

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Location:
Gaithersburg, MD
Posted Date:
8/22/2017
Position Type:
Full time
Job Code:
R-011408
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

Location: Gaithersburg,
Maryland,
United States
Job reference: R-011408

Posted date: Aug. 09, 2017



Supply Chain Study Manager

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Supply Chain Study Manager in Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Supply Chain Management is within AstraZeneca Pharmaceuticals Pharmaceutical Technology and Development (PT&D) organization and part of AstraZeneca Operations. AZ Supply Chain Management is responsible for design, demand, manufacture and delivery of the end to end Supply Chain of Clinical Trials Material.

The Supply Chain Study Manager (SCSM) is a key team leader with responsibility to design, plan and manage the supply chain of clinical trials material for patients taking part in AstraZeneca clinical trials all over the world. The SCSM works in close collaboration with customer functions to influence and manage demand for individual clinical studies and is responsible for their supply chain deliverables. The SCSM is a member of the Supply Chain Team for a drug program.

Main responsibilities:

  • Leads and provides direction to Study Drug Working Groups (SDWGs) with members from R&D Supply Chain, Clinical Development and external partners.
  • Ensures the team delivers clinical supplies effectively and consistently, balancing cost and risk to supply with expert input and support from cross functional groups.
  • Understands and translates clinical study protocol requirements into demand for drug product within a clinical study. Authors the drug supply section of Clinical Study Protocol and leads development of master label text.
  • Uses simulation tools and supply chain expertise to design optimized, lean supply chains for individual studies and ensure delivery of the end to end supply of materials to meet study needs.
  • Uses forecasting tools to have the appropriate amount of drug at the appropriate location during the study duration.
  • Defines IRT (recruitment and drug management software) user requirements, sets up IRT and ensures timely go-live for individual studies. Uses IRT to track recruitment and adjust IRT parameters to accommodate any changes in study scope and design.
  • Collaborates with CRO partners in development of pack design and reviews the technical part of the outsourcing contract. Reviews changes to the contract with CRO partners and Sourcing Managers as necessary.
  • Works within GMP Quality Management System, including managing deviations, complaints, change controls as appropriate, and provides documentation to electronic trial master files.
  • Monitors the budget for individual study supply activities and materials for the project. Flags deviations to SC Program Manager. Manages change in demand and supply, resolves issues, and escalates when appropriate.

Requirements

Essential Requirements

  • Bachelor of Science degree in related discipline, preferably in medical, biological, or health related sciences; advanced degree preferred
  • Experience (5+ years) working in supply chains OR clinical study management OR working in pharmaceutical drug development
  • Track record of successfully managing multiple projects
  • Documented strong leadership and change management capabilities
  • Strong influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries
  • Proactive risk identification and management
  • Excellent written and verbal communication skills
Desirable Requirements
  • Understanding the drug development process and R&D supply chains
  • Knowledge of clinical development processes relevant to the supply of clinical materials, egg experience managing global clinical trials
  • Background in Good Manufacturing Practice (GMP) or Good Clinical Practice (GCP)
  • Project Management credential (eg PMP)

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.