| Job Description | Job Description
Successful candidates will be AstraZeneca Employees and will be located at AstraZeneca's MedImmune strategic science center in Gaithersburg, Maryland. MedImmune is the worldwide biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines.
As the Associate Director Clinical Development you will be responsible for leading the project planning and operational delivery of clinical work packages in Clinical Operations, GMD. The span of activities is broad covering clinical activities in late drug development, registration/submission and post registration product maintenance phases and will include local and global working.
The role is to lead and manage defined clinical deliverables across a broad range of activities. This can include the responsibility to lead complex components of a clinical program such as Life Cycle Management, clinical submission activities, or indication development responsibilities or lead independent work packages or maintenance projects. Tasks involve project planning and operational delivery of clinical programmes, and project management of the scope, schedule and budget. In addition to clinical work in drug projects, the ADCD may manage improvement or change projects in other business areas.
The ADCD may be aligned to one or more projects depending on size and complexity and is responsible to the Director Clinical Development for the program
Responsibilities:
* Responsible for leading a cross functional team of clinical experts in the planning and delivery of a defined clinical project to scope, quality, budget, time, managing resource and risk (e.g. large studies/package of studies, submission planning, regulatory defense, inspection readiness, payer evidence)
* Responsible for project management including the development, baselining and maintenance of realistic, up to date and appropriate quality, project and study plans (including timings and total costs) in agreed systems (such as IMPACT, OPAL and ACCORD)
* Provide input into study feasibility, study specifications, vendor/partner contracts and essential documents such as clinical study protocols
* Lead a large/complex work package or manage a clinical study and the process to identify and solve operational issues and drive delivery to plan through internal or external partners (Alliance partners, CROs, vendors and Academic Research Organizations).
* Act as AZ operational interface with external (e.g. CRO/ARO) partners for externally managed/outsourced studies as appropriate
* Responsible for ensuring timely compliance with companywide governance controls (e.g. Sarbanes-Oxley, ACCORD access and study attestations, continuous assurance, Letter of Assurance and Clinical Trial Disclosure)
* May be assigned responsibility for leadership and program/project management of non-drug project work
Demonstrate AstraZeneca Core Values
* We follow the science and put patients first
* We play to win
* We do the hard right thing, rather than the easy thing
* We are candid in our relationships and treat people with respect
* We are entrepreneurial |
| | Company | | MedImmune | Job Code | | State or Province | | Maryland | | |
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