At AstraZeneca, we're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.
Our strategy and ability to transform our portfolio means we have a late stage pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines. We transform clinical concepts into medicines that deliver patient health benefits.
Join us as an Associate Director of Clinical Operations in Oncology late stage development, where you can be a part of turning exciting science and innovative molecules into medicines that change lives. Our broad pipeline of next-generation immuno-oncology medicines is focused principally on four disease areas - breast, ovarian, lung and haematological cancers. As well as other tumour types, these are being targeted through four key platforms: immunotherapy; the genetic drivers of cancer and resistance; DNA damage repair; and antibody drug conjugates. This opportunity is available in either our South San Francisco, Gaithersburg, or New York City offices. It is not a remote opportunity.
By driving the late stage development of our pipeline, we enable the business to make critical pipeline and investment decisions. In this role, you will be responsible for leading the project planning and operational delivery of clinical work packages. 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.
You will 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 programs, and project management of the scope, schedule and budget.
- Lead cross functional teams of experts in the planning and delivery of a defined clinical program of studies and/or clinical activities to scope, quality, budget, time; managing resource and risk
- Work closely with individual study leaders to provide appropriate oversight of a program of studies on behalf of Director Clinical Development (DCD)
- Provide clinical operations expertise into the project (e.g. country selection, feasibility, operational input into design, external partner management) to support governance interactions and project start-up.
- Support the DCD in providing clinical operations expertise into the development of new business case opportunities for review by governance bodies (cost, timelines, feasibility, risk)
- Provide project leadership & management to cross functional Clinical Submission Teams in planning and execution of clinical contribution to Marketing Applications (aligning closely with other key contributors to submission package)
- On behalf of Clinical Project Team, manage clinical plans (cost, FTEs and timelines) in business reporting system, such as PLANIT
- Be early adopter for new ways of working and act as ambassadors for change when leading teams
- Identify and resolves issues within the clinical project ensuring the escalation of the issue to the appropriate individual/functional/governance group for resolution
- Lead large or complex deliverables (i.e. indication) 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 project interface as escalated from study teams with external (e.g. CRO) partners for externally managed/outsourced studies as appropriate
- Responsible for leadership and program management of non-drug project work as assigned, eg cross functional improvement initiatives
- Contribute to functional and cross-functional initiatives as Subject Matter Experts
- Mentor and support people development within Clinical Operations and other functions
- Bachelor's degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
- At least 10 years' experience from within the pharmaceutical industry or similar large multinational organization.
- Proven knowledge of clinical operations, project management tools and processes
- Proven experience of clinical development / drug development process in various phases of development and therapy areas.
- Proven ability to learn by working in multiple phases, TAs and/or different development situations.
- Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development).
- Ability to mentor, develop and educate staff
- Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives
- Skilled & experienced in change management
- Ability to look for and champion more efficient and effective methods/processes of delivering Clinical Development focusing on key performance metrics around reliability, productivity, cost and quality
- Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization
- Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a regional and local environment
- Integrity and high ethical standards
- Project management certification is desirable but not mandatory.
- Knowledge of process improvement methodology such as Lean Sigma/Change Management is desirable but not mandatory
- Regulatory submission experience