Emmanouil Volikos

Led cross-functional teams of 10+ members to deliver complex clinical trials on time and within budget, consistently exceeding client expectations. As the primary owner of all project deliverables, prepared project plans and ensured timelines were met.

Managed a team of in-house and outsourced associates, overseeing clinical project start-up activities and ensuring regulatory compliance. Supported cross-functional business development activities, contributing to departmental and overall business annual targets.

Supported the development program of FASENRA (Benralizumab) primarily in the EU within a global regulatory program management role. Prepared and delivered regulatory, operational, and risk mitigation plans for MAA application preparations.

Led global regulatory projects for Clinical Trial Applications, planning workload for initial CTA submissions, deficiency responses, and amendments. Ensured regulatory compliance across a range of markets and led the update of the regulatory compliance database for FASENRA.

Served as Global Regulatory Project Lead on clinical research projects, managing regulatory strategy plans and executing them on time, quality, and cost. Provided input into financial forecasting and managed budget allocation for participating countries.

Responsible for study start-up activities of Phase I-IV clinical trials, medical device, and non-interventional studies. Led a team of 5 as the UK Study Start-Up (SSU) coordinator for Pfizer Strategic Partnership, ensuring timely completion of activities.

Developed the Multiple Myeloma clinical trials portfolio and project managed the start-up of an Investigator-initiated phase II clinical trial. Contributed to the advancement of clinical research in oncology.

Planned the care and support of patients according to trial protocols in oncology and hematology. Autonomously managed a caseload of patients within a multidisciplinary team.

Planned and conducted laboratory-based research projects, managing databases relevant to laboratory research. Conducted Bioinformatics data analysis and prepared data for presentations and publications.

Activities and societies: Indicative Course: Statistical Programming

Completed a Master of Science in Human Molecular Genetics at Imperial College London. Focused on advanced topics in genetics, including statistical programming.

Obtained a Bachelor of Science in Genetics & Molecular Biology from Wolverhampton University. This program provided a foundational understanding of genetic principles and molecular biological techniques.

Activities and societies: (Completed @Wolverhampton Univ)

Undertook a Bachelor of Science in Genetics at the University of Wales, Cardiff, with the degree completed at Wolverhampton University. This coursework laid the groundwork for further studies in genetics.