Director Study Leader - Cell Therapy

Gaithersburg, Maryland

This job has expired.

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!

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.

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 is responsible for delivering a single or several smaller development programs or leading multiple studies or single complex/novel studies such as platform, basket, etc.

  • The exact accountabilities will differ depending on the exact nature of the clinical program so a high degree of flexibility and autonomy is required.
  • This role may also provide expert input to other non-drug programs and improvement projects.
  • Provides expert clinical operational input into project or study level documents, for example clinical development plan, clinical study protocol, clinical study report, and may lead the delivery of study documents
  • With oversight from the Sr Director, may lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions
  • Leads the delivery of the clinical study(s) or program(s) from concept to final CSR and through to study closed and archived to agreed budget, time, project standards, quality and scientific standards
  • Accountable for overall study or program deliverables, maintaining oversight throughout the life of the study or program by close interaction with individual study/program leaders or leadership of the study team as appropriate
  • Ensure sponsor oversight throughout the life of the study
  • Develops and manages effective risk management/mitigation plans to ensure timely delivery to quality, budget and time and advance issues to partners as appropriate
  • Responsible for planning and leading issue escalation and resolution
  • Provide input to forecasting and management of study/program delivery costs, resource and timelines
  • Accountable for the quality of study/program planning information into relevant planning systems
  • Mentors and supports development of individuals within the organization
  • Contributes to operational interactions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators
  • Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs
  • Responsible for study or program level reporting of progress, risks and issues
  • Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
  • Provision to procurement clear specifications for study or program specific outsourcing
  • Review and operational approval of study or program specific contracts or work orders

Essential for the role
  • Bachelor's degree in related subject area, preferably in medical or biological science.
  • Minimum of 8 years of drug development experience from within the pharmaceutical or biotech industries
  • Extensive experience in leading studies/programs in clinical development
  • Proven experience in Cell Therapy
  • Comprehensive knowledge of the clinical and pharmaceutical drug development process
  • Extensive and proven experience in driving operational delivery to timelines, cost and quality
  • Proven experience leading delivery through internal and external organizations.
  • Excellent knowledge of ICH-GCP principles
  • Project Management experience within the context of Clinical Drug Development
  • 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
  • Ability to lead strategic and/or operational management of individual clinical trials
  • 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
  • Advance degree
  • Program management qualification (e.g. MBA, PRINCE2, PMP)
  • Experience in variety of academic/CRO/Sponsor organizations and countries
  • Experience of early phase clinical delivery

This role can be located at our Gaithersburg, MD or Waltham, MA site.

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 then 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 program, including paid time off, 401K contributions, performance development, performance recognition scheme and a competitive, generous remuneration package.

AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants. COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn

Follow AstraZeneca on Facebook

Follow AstraZeneca on Instagram


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