Study Manager, Logistics & Clinical Supply (LCS)
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration through scientific research. Here, employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.
We are seeking a Study Manager to join the Logistics & Clinical Supply (LCS) team in a full time office based role in Gaithersburg, MD
This is a complex and interactive job requiring excellent communication skills, combined with an ability to troubleshoot a range of problems. As Study Manager, you will focus on delivering solutions to complex problems requiring ingenuity and creativity. We require an individual who can achieve results through both formal and informal networks and who can effectively multi-task across activities of varying priority. In this position, you are expected to demonstrate the ability to recognize activities or events that may critically affect study supply and act on or relay that information to the appropriate party. You will act as a highly effective representative for Study Management as the primary technical contact on assigned projects. We require you to have the emergent management skills appropriate to an effective mentor, and the skills to coach and train their colleagues in LCS Study Management activities where required.
AstraZeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent. Do you want to join a growing company with an incredible product pipeline?
Main Duties and Responsibilities
- Independently plan and lead all aspects of Investigational Product (IMP) supply for assigned clinical studies
- Work collaboratively within LCS to oversee seamless delivery of Vendor, Distribution and Systems management activities
- Liaise with interfaces and partners internally and externally as required to ensure highly effective clinical supply planning and execution, including on-going responsiveness to any changes that may impact supply strategy.
- Contribute to the operational effectiveness of Logistics and Clinical Supply
- As a member of the Supply Continuity Team (SCT) contribute to and influence the development /supply strategy for assigned studies, ensuring that risks / opportunities for supply optimization are discussed
Minimum Education Requirements:
- Bachelors degree in basic/applied science or engineering and a minimum of 10 years of relevant experience
Masters degree in basic/applied science or engineering and a minimum of 8 years of relevant experience
PhD / PharmD and some experience preferred
- Experience in planning and delivering all aspects of IMP management for clinical studies, ideally including oversight of vendors leading GMP operations.
- A deep understanding of cGMP, GCP and ICH guidelines as related to IMP management.
- Experience in the Biotechnology and/or Pharmaceutical industry
- Preferably you will have a sound understanding of the drug development process and ideally also demonstrable success in delivery of cross-functional projects and/or activities
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.