Stephen P.

Leading the development and implementation of advanced analytics strategies to optimize the GSK Global Clinical Operations (GCO) Organisation. My team's mission is to empower GCO with data-driven insights by defining and delivering analytics models for planning, forecasting, study design, and site selection. We will pioneer the use of AI/ML and generative AI to enhance clinical operations tooling and drive the integration of internal and external big data sets into decision-making. Responsible for building and managing a high-performing analytics team, fostering innovation, and collaborating with senior stakeholders to shift the organization to an insight-driven approach.

At AstraZeneca, we're revolutionizing healthcare by embedding digital health solutions at scale to improve patient experiences and outcomes. As a key member of the Digital Health Innovation team in Product and Portfolio, I lead transformation and innovation projects that empower cross-functional R&D teams worldwide. By leveraging digital, data, and analytics, we achieve accelerated timelines, cost reduction, enhanced patient experiences, and reduced carbon emissions. I thrive on challenging the status quo, stimulating creativity, and driving continuous improvement. With a global remit, my role touches multiple areas of the business, delivering thought-provoking projects and making a significant impact. Let's connect and discuss how we can shape the future of healthcare together!

I drive cross-functional teams in delivering cutting-edge products that revolutionize R&D clinical trial monitoring and delivery. Leveraging my expertise in agile product development, risk management, and strategic prioritization, I shape a compelling product vision while offering guidance and mentorship. As a change agent, I lead seamless global roll-outs, consistently achieving impactful results in this dynamic and rapidly evolving landscape. My proven track record showcases my effective leadership in this field.

Accomplished Global Study Associate Director (GSAD) with a proven track record in successfully leading and delivering Phase III clinical studies, specifically in the NSCLC - Imfinzi field. As a pivotal member of AstraZeneca Global Medicines Development, I played a critical role in driving the strategic execution of clinical studies. I skillfully led cross-functional teams of experts, providing direction and guidance to ensure the seamless delivery of studies within strict timelines, allocated budget, and stringent quality standards. Through my exceptional leadership and effective partnership building, I fostered a collaborative environment that optimized study outcomes. This experience honed my expertise in project management, stakeholder engagement, and driving operational excellence.

Led a comprehensive Phase I-III Global Oncology Program focused on Tagrisso, where I established and nurtured relationships with key stakeholders, ensuring seamless communication with marketing companies and Strategic Partners to achieve operational objectives. Directed and coordinated clinical research activities, collaborating with local study leaders across Europe, Asia, and North America to manage timelines, submissions, and recruitment. Provided oversight for global and local drug supplies, ensuring efficient management and delivery.

Driving business growth by identifying and capitalizing on new opportunities and forging strategic partnerships with pharmaceutical and biotech companies. Proactively exploring avenues for expanding the company's activities and establishing mutually beneficial collaborations to enhance market presence and drive revenue growth.

Senior Clinical Research Associate at AstraZeneca: - Led international Phase III clinical trials in Oncology (5 studies, 20 sites) and Infectiology (1 study, 10 sites) - Actively participated in international Investigator meetings - Developed collaborative relationships with sites through site qualification visits, site initiation visits, interim monitoring visits, remote monitoring, and study closeout visits in compliance with ICH-GCP, local regulations, Global SOPs, and study monitoring guidelines - Contributed to the development of study tools Senior Consultant at Excelya: - Played a key role in candidate recruitment, interviewing, and coaching - Managed corporate event projects - Led bid defense meetings - Conducted vendor/client selection and management, proposal analysis, and discussions - Provided clinical research training

International clinical trials Phase II: Leukemia (15 sites) -Conducted Initiation, Monitoring in accordance with ICH-GCP, local regulation, Global SOPs and study monitoring guidelines in France - Develops collaborative relationships with investigational sites - Coordination activities within Feasibilities, Selections and Databases lock - Essential documents collection, management, translations, back-translations (French, English). - CRF Collection, follow-up and data queries resolution, study progress reporting to Clinical Trial Manager and/or Sponsor - Management of study drug accountability and SAEs in collaboration with PVG and medical departments for the reporting of safety information -Contracts, fees and overcasts management -Experienced with paper CRF, eCRF systems and CTMS - Involves in tools improvement

International clinical trials (Phase II, III and IV): Breast cancer (PIII - 12 sites 80 subjects), Prostate cancer (PIII - 14 sites 70 subject), Lung cancer (PII - 6 sites - 30 subjects) and Crohn's Disease (PIV - 15 sites 1000 subjects) -Conducted Evaluation, Initiation, Monitoring, and Close-out visits in accordance with ICH-GCP, local regulation, Global SOPs and study monitoring guidelines in France and Switzerland

Pharmacochemistry / Drug Design focus on Cancer and Diabetes Therapy

Research in Fragment-based Drug Design (In Silico)