Do you have expertise in Oncology, and a passion for cellular therapy?

Would you like to apply your expertise to impact the lives of patients living with cancer, in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company 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.

A place built on courage, curiosity and collaboration – we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team.

This position can be located in Oncology HQ in Gaithersburg MD or our modern facility in Waltham MA.

Business area

Pioneers of collaborative research we have built an unrivalled scientific community both internally and externally. Fusing academia and industry, we have united some of the world’s foremost medical centers. Working seamlessly and inclusively, together we expedite research in some of the hardest-to-treat cancers.

Do you want an opportunity to build a rewarding and meaningful career as part of the team committed to improving the lives of millions with cancer?

What you’ll do

The Associate Director Study Leader Cell therapy, Oncology R&D is responsible for the delivery of clinical studies including quality, timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines. Provides matrix management of functional area representatives to cross functional clinical study teams. The exact accountabilities will differ depending on the exact nature of the clinical program so a high degree of flexibility is required.

• Leads the delivery of the clinical study from concept to final CSR and through to study closed and archived to agreed budget, time, project standards, quality and scientific standards
• May convene and lead the cross functional study team(s) for Early Oncology Clinical studies based on delivery model
• Lead and optimize the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedback for study team members to the appropriate AZ manager or CRO representative
• Contribute to developing, implementing and updating SOPs, study protocols, laboratory manuals, ICFs and other study-related documents
• Responsible for forecasting and day-to-day management of study timelines, budget, materials and detailed study level plans and feasibility assessment
• Implement agreed study level process and technology for Early Oncology – Cell Therapy clinical studies
• Manage to the agreed study timelines, budget, and resource and ensure the update of appropriate systems
• Accountable for the quality of study planning information into relevant planning systems
• Guide the study team in the development of outsourcing specifications and vendor selection
• May manage the vendor(s) throughout the life of assigned clinical trial(s) based on delivery model
• Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs
• Lead and conduct investigator meetings and other study related meetings
• Identify and communicate resource gaps for assigned studies
• Communicate study level reports and status updates for Early Oncology clinical studies
• Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
• Oversee the submission of trial-related and essential documents to the Trial Master File, maintenance and final closeout of TMF
• Ensure sponsor oversight throughout the life of the study
• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness
• Responsible for study level reporting of progress, risks and issues
• Provision to procurement clear specifications for study specific outsourcing
• Review and operational approval of study specific contracts or work orders

Essential for the role

• Bachelor’s degree in related discipline, preferably in medical or biological science
• Cell therapy trials experience
• Progressive experience in clinical research, with exposure to clinical development project management experience or equivalent
• Comprehensive knowledge of the clinical and pharmaceutical drug development process
• Excellent knowledge of ICH-GCP principles
• Extensive and proven experience in driving operational delivery to timelines, cost and quality
• Proven experience leading delivery through internal and external organizations
• Experience and strength in working and leading in matrix teams
• Strong collaborative communications skills including the ability to engage with a diverse client base and manage through conflict
• Proven ability in problem solving and issues management that is solution focused
• Experience in providing clear requirements for external contracts
• Experience in selection of external providers and development/review of contracts
• Proven oversight of external providers

Desirable for the role

• Higher degree e.g. PhD, MSc, MPhil
• Program management qualification (e.g. MBA, PRINCE2, PMP)
• Experience in variety of academic/CRO/Sponsor organizations and countries
• Experience of early phase oncology clinical delivery

Why AstraZeneca?

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, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
• If you’re curious to know more, please get in touch. We would welcome your application, and look forward to speaking with you soon.

The successful candidate will have access to a comprehensive benefits and renumeration package.

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Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

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Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.