Associate Director, Vendor Management

**About AstraZeneca**

AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

**About the team**

Logistics and Clinical Supply is a key group embedded within Biopharmaceutical Development (BPD), the large molecule CMC development powerhouse of AstraZeneca. As part of our team is in Gaithersburg, MD you will play a pivotal role in bringing BPD science to patients. We’re right at the front end of an integrated R&D organization delivering life-changing new medicines to clinical trials worldwide. In this role you’ll have the opportunity to work across all of our key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, infection and vaccines. We offer a unique and strong collaborative network as part of the broad AstraZeneca family, while at the same enjoying the agility and connectivity of a close, innovative team.

**Main Duties & Responsibilities**
- Provide general oversight to IMP related vendor activities outsourced by LCS, ensuring highly effective sourcing, deployment and management of IMP related vendors
- Influence, own and promote functional deployment of optimal working practices, systems, and tools, to ensure robust vendor management activities
- Create, manage and report functional budgets across LCS including provision of support to PO’s, invoices and budgetary planning processes such as ABU/RBU
- Create, deliver and maintain project budgets for assigned clinical studies, including addendums where required for additional scope of work and arrangements for study contract closeout with vendor
- Collaborate within LCS to ensure highly effective matrix working enabling successful on-time delivery of quality IMP and AMP to all relevant clinical studies
- Maintain & expand close cross-functional relationships internally and externally, to best identify, select and establish contractual arrangements with appropriate vendors to support IMP activities for all relevant clinical studies
- Liaise closely with Quality Assurance (QA) to coordinate activities relating to, Quality Agreements, Quality Audits, Quality Oversight and all other such activities as expected in accordance with cGMP, GCP, & ICH guidelines

**Education & Experience Requirements**

**Education**
- Requires a bachelor’s degree in basic or applied science or engineering, and may have a higher-level qualification such as a master’s degree. The Associate Director will have appropriate direct experience in a development or technical operations environment in the biopharmaceutical and/or health care industry. Specific experience in the management and supply of IMPs is highly desirable.

**Required Skills**:

- Direct knowledge and understanding of vendor management to support clinical supply activities including experience in selection of third-party vendors, reviewing vendor bid and contract negotiation.
- Broad knowledge of biopharmaceutical product development and demonstrated ability to achieve results in a cross-functional, multi product environment.
- Some experience in planning and managing all aspects of IMP management for clinical studies, including oversight of vendor management of GMP operations. Thorough understanding of cGMP, GCP and ICH guidelines as related to IMP management.
- Experience with international clinical study design including sourcing and supply of materials such as items to support dose preparation and administration, and/or comparators.
- Experience managing people (either as line or matrix manager) preferred, and proven ability to work in a dynamic environment and collaborate within cross functional teams to deliver complex projects.

**Special Skills/Abilities**:
This position requires a high level of commitment, flexibility, initiative and independence, with strong skills for planning, coordination, teamwork, communication and interpersonal relations. The Associate Director will be highly organized and have strong analytical skills whilst demonstrating with keen attention to detail, aptitude for technical troubleshooting on IMP vendor contracts and activities, and appropriate tact and diplomacy in building / managing interface relationships.

**Job Complexity**:
This is a complex and highly interactive job requiring excellent communication and influencing skills, combined with

demonstrated technical aptitude. The position requires an individ