米歇尔样本 - AstraZeneca-澳门在线赌城娱乐

As Vice President of Late Stage 肿瘤学 Clinical Operations at AstraZeneca, 我领导着一个超过1人的团队,500 dedicated employees who provide the clinical operations and study program management expertise for all late-stage 肿瘤学 programmes. 每年, 澳门第一赌城在线娱乐为成千上万的患者提供临床试验, 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, 综合临床操作团队. The success of clinical operations is rooted in collaborative, 需要整体思维的多学科工作. 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, 新的疾病终点, 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. 从研究入组到试验后准入, I’m driven to make it easier and faster for people to access the treatments, 提高临床试验的经验.

米歇尔样本 VP, Late Stage 肿瘤学 Clinical Operations, AstraZeneca

2020年至今

我负责肿瘤学项目管理, 研究管理, 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 肿瘤学 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

作为副总裁 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, 欧盟和日本. This period included an ambitious expansion and restructure program, 以及新技术的成功推广. All underpinning Phase I-III global clinical trials across data management, 医学写作, 临床操作及临床试验后勤.

2015 to 2016

作为副总裁, 肿瘤学 I played a key role in the global merger of the GSK and Novartis 肿瘤学 research portfolio. 澳门第一赌城在线娱乐转移了超过234个全球临床试验, 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.

2012 to 2015

I oversaw the integration and globalization of 250 colleagues in GSK 肿瘤学 clinical and operations organizations as VP, 肿瘤TA输送. 拥有20亿美元的全球研究预算, I implemented strategy securing six approved NDAs/SNDAs.

2006 to 2012

As GSK Senior Director Global Clinical and Operational Sciences I facilitated key leadership programs, 为肿瘤学资产制定战略计划, and secured the appropriate placement of clinical trials to epidemiological data and regional needs. 在此期间, 我在公司足迹中增加了12个国家, established an integrated business unit and expanded programs into Asia Pacific and Japan. I also carried out a coordinated review of clinical plans with regulatory, commercial and medical to ensure trials aligned with registration strategy and commercial requirements.