As Vice President of Late Stage Oncology Clinical Operations at AstraZeneca, I lead a team of more than 1,500 dedicated employees who provide the clinical operations and study program management expertise for all late-stage Oncology programmes. Each year, we deliver clinical trials for thousands of patients, which can lead to approvals for life-changing cancer treatments across the globe.

Throughout my 30 years of industry cancer drug development experience, including my prior executive appointments at GlaxoSmithKline and Incyte, I have been devoted to reimagining clinical trial execution and how we engage with patients. I am proud to lead a global team who shares my commitment to designing clinical programmes with diversity at the forefront— accounting for racial and ethnic minority groups and other populations experiencing health disparities, including sexual and socioeconomic gender minority or socioeconomic disadvantaged populations.

What I have most enjoyed throughout my career is growing strong, integrated clinical operations teams. The success of clinical operations is rooted in collaborative, multi-disciplinary work that takes a holistic mindset. AstraZeneca’s programmes demand this big-picture focus, as well as courage and resourcefulness. This is because we are carrying out increasingly complex trials with very specific patient populations, novel disease endpoints, and greater engagement with healthcare professionals— all to improve the outcomes of patients with cancer.

My lifelong passion lies in delivering for patients and achieving clinical trial delivery excellence. With my background in nursing, patients are at the forefront of everything I do. From study enrolment to post-trial access, I’m driven to make it easier and faster for people to access the treatments, and to improving the clinical trial experience.

Michele Sample VP, Late Stage Oncology Clinical Operations, AstraZeneca
Headshot of Michele Sample, Vice President of Oncology R&D Clinical Operations, at AstraZeneca

CURRENT ROLE

VP, Late Stage Oncology Clinical Operations, AstraZeneca

2020 to present day

I oversee Oncology program management, study management, site management and monitoring at an incredibly exciting time for AstraZeneca with arguably the strongest pipeline in the industry! I am proud to be responsible for Phase II and III global clinical trials across the Late Oncology Clinical Operations in 25 key markets. It’s my mission to support our teams in making an even bigger difference to address unmet medical need around the world.

2016 to 2020

As VP Development Operations at Incyte I oversaw a $500m budget and secured the timely to budget delivery of 16 compounds across 18 plus indications with a 125-strong team spanning the US, EU and Japan. This period included an ambitious expansion and restructure program, and the successful rollout of new technology. All underpinning Phase I-III global clinical trials across data management, medical writing, clinical operations and clinical trial logistics.

2015 to 2016

As VP, Oncology I played a key role in the global merger of the GSK and Novartis Oncology research portfolio. We transitioned over 234 global clinical trials, and evaluating synergies across systems and processes to implement the Transfer of Obligations process including submission to regulatory and country specific government agencies. The transfer of sponsorship was completed without any interruption to patient supplies through careful alignment on drug manufacturing and distribution. I also maintained clinical programs in support of three regulatory submissions during this time.

Veeva ID: Z4-61559
Date of preparation: February 2024