AstraZeneca

Clinical Study Supply Lead


PayCompetitive
LocationGaithersburg/Maryland
Employment typeFull-Time

This job is now closed

  • Job Description

      Req#: R-193338

      Are you passionate about designing, planning, and managing the supply chain of clinical trial material for patients participating in clinical trials? If so, the role of Clinical Supply Study Lead at AstraZeneca could be your next career move! As a Clinical Supply Study Lead (CSSL), you will play a pivotal role in designing, planning, and managing the supply chain of clinical trial material for patients participating in AstraZeneca clinical trials worldwide.

      The Clinical Supply Study Lead will work closely with customer functions to influence and manage demand for individual clinical studies and will be responsible for their supply chain deliverables. As a CSSL, you will be a valued member of the Supply Chain Team for a drug program.

      What you will do:

      • Lead and provide direction to Study Drug Working Groups (SDWGs) with members from R&D Supply Chain, Clinical Development, and external partners.

      • Ensure that the team delivers clinical supplies effectively and consistently, balancing cost and risk to supply with expert input and support from cross-functional groups.

      • Understand and translate clinical study protocol requirements into demand for drug products within a clinical study. You will author the drug supply section of Clinical Study Protocol and lead the development of the master label text.

      • Use 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.

      Minimum Qualifications:

      • Bachelor’s with 2 years, Masters with 1 year, and PharmD with 0-1 year role relevant experience OR working in pharmaceutical drug development OR clinical study management OR GMP manufacturing, supply chain, project management

      • Track record of successfully managing multiple projects

      • 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

      Preferred Qualifications:

      • Understanding the drug development process and R&D supply chains

      • Knowledge of clinical development processes relevant to the supply of clinical materials

      • Background in Good Manufacturing Practice (GMP) or Good Clinical Practice (GCP)

      • Project Management credential (eg PMP)

      When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

      Why AstraZeneca?

      At AstraZeneca, we are driven by innovation and our commitment to deliver life-changing medicines to patients worldwide. With a constant flow of new products and launches, there's never been a better time to join our Supply Chain team. Our resilience helps us thrive as we innovate and evolve in rapidly changing markets. We foster an encouraging, positive environment where ideas are welcomed and rewarded. If you are driven, take smart risks and can act quickly, then this is the place for you. Our contribution to life-changing medicines is why people have been here for decades. We do it for the patients.

      Ready to make a big impact? Apply now and join us in our mission to deliver life-changing medicines!

      Date Posted

      17-Apr-2024

      Closing Date

      28-Apr-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

      AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
  • About the company

      AstraZeneca PLC is a British-Swedish multinational pharmaceutical and biopharmaceutical company with its global headquarters in Cambridge, England.