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Group Director Study Operations, Early Oncology Clinical

Location Gaithersburg, Maryland, United States Job ID R-199998 Date posted 23/05/2024

Are you excited about Clinical Development and Study Operations? Would you like have an impact on patients’ lives and contribute to eliminate cancer as a cause of death? If so then join us!!

Business area

Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It’s our big vision that unites and inspires us. 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 calculated risks that write the next chapter for our pipeline and Oncology team.

We are focused on identifying and treating patients earlier, where there is greater curative potential. With the greatest number of early stage cancer trials in the industry, we are getting closer to finding cures every day.

It’s our unique people-first approach that keeps us grounded and inspired to improve outcomes for all. Listening to our patients to evolve with their needs and tailor their medicines.

Come and join our AZ team where you will play a pivotal role in this exciting period of development!

What you’ll do

The Group Director Study Operations is accountable for the line management and development of a team of clinical operations specialists supporting the delivery of early phase oncology clinical studies, and will lead or participate in functional activities supporting day to day business as well as change and improvement projects. The Group Director Study Operations may also take on the responsibilities of the Director Study Leader for delivering development programs or leading multiple studies / single complex studies. The exact accountabilities will differ and so a high degree of flexibility and autonomy is required. Duties Include:

  • Management, development and career progression of clinical operations professionals
  • Recruitment and retention of staff
  • Ensure the team is appropriately trained and developed to be in sync with all company and regulatory standards
  • Conduct ongoing performance development and complete the required steps of the performance development cycle
  • Resource management and efficient deployment of staff to clinical studies/programs
  • Oversight of quality and compliance of the group to ensure inspection readiness
  • Driving efficiencies and innovation across the operational skill group
  • Work closely with the Leadership Team to drive strategy and business performance
  • Development and maintenance of processes owned by the group
  • Drives productivity improvements and innovation within the group
  • Lead/participate/represent Study Operations in strategic work streams

In addition to the full line management accountabilities, the Group Director Study Operations may undertake responsibilities of the Director Study Leader, Early Oncology Clinical:

  • 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 Senior 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/program results, maintaining oversight throughout the life of the study/program by close interaction with individual study/program leaders or study leadership team as appropriate
  • Contributes to operational interactions with external entities including regulatory agencies, preferred partners/suppliers and collaborators
  • Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies/programs

Required Experience, Skills, and Qualifications

  • University degree in related discipline, preferably in medical or biological science, or discipline associated with Clinical Research
  • At least 10 years drug development experience demonstrated in a variety of roles.
  • At least 5 years of experience in leading studies in clinical development.
  • Significant experience in operational support and delivery in early clinical development
  • Ability to lead, coordinate and prioritise multiple tasks and deliverables
  • Proactive approach
  • Ability to manage change and actively seek and champion more efficient and effective ways of working
  • Line management experience, preferable

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 envisioning yourself joining our team? Good, because we can’t wait to hear from you.

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.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.