Q1. Tell me something about yourself?
With an extensive background spanning various companies, including both Contract Research Organizations (CROs) and Biopharma companies, I have amassed a wealth of experience across different roles within medical and clinical departments.
Throughout my career, I have consistently taken on increasing responsibilities, showcasing adaptability and a proactive approach to leadership. This diverse professional journey has equipped me with a holistic understanding of the spectrum of clinical and medical complexities within the industry.
I have always enjoyed working in clinical development and contributing to the execution of clinical trials, ensuring their success from conception to fruition. Being an integral part of this process allows me to witness the tangible impact on patients, driving my commitment to advancing treatment options and improving healthcare.
Q2. With 20 years of experience leading scientific research projects across multiple therapeutic areas, could you provide an example of a particularly complex project you've managed, from concept to successful conclusion, and share the key strategies that contributed to its success?
From various projects with demanding deliverables i will refer to a recent one which involved managing and aligning an oncology research network, multiple clinical sites, principal investigators (PIs), and project recruitment targets.
Having multiple stakeholders, each with different perspectives, the potential for challenges and complexities significantly increases. Divergent viewpoints among various parts involved in a project can lead to miscommunication, conflicting priorities, and a lack of cohesive decision-making.
Successfully orchestrating collaboration among diverse stakeholders with varying priorities, I've employed adept communication and strategic decision-making to harmonize processes and standardize procedures. Overcoming the challenges of differing perspectives and institutional nuances, I ensured the optimization of resources across the network and sites while meeting the company’s expectations for project timelines and outcomes.
Q3. You mention your ability to mentor cross-functional teams and develop research programs and best practices. How do you approach team leadership and program development to ensure the achievement of business objectives in a dynamic research environment?
Regarding cross functional mentorship, I strongly believe in fostering a collaborative and inclusive team culture. As a leader, I aim to mentor teams by encouraging open communication, valuing diverse perspectives, and promoting a culture of sharing experience. This approach not only enhances individual team members' skills but also creates a cohesive and innovative work environment.
Another important aspect is to ensure that the team is aligned with the overall business objectives, and for that reason I always provide clear direction to achieve milestones. This includes setting realistic timelines, allocating resources efficiently, and regularly assessing progress against predetermined benchmarks.
Since i am involved in global projects I act as a collaborative partner to trial investigators, global study teams, and country operations team. Effective communication is at the core of my strategy, ensuring that all stakeholders are well-informed and aligned with the project's trajectory, promoting a transparent and efficient exchange of information.
Finally, I embed a culture of diversity and inclusion in all aspects of trial management. This ensures that different perspectives are considered, leading to more robust and adaptable research programs.
Q4. Overseeing the full clinical development lifecycle is a multifaceted responsibility. Can you discuss the challenges and key milestones you've encountered while managing the clinical development process from discovery to phase-IV trials?
Given the highly regulated environment of clinical trials, meticulous planning and adaptability is necessary to ensure compliance throughout the development process. Achieving regulatory milestones and adaptation to the requirements of the new EUCTR regulations which is now binding on all EU member states is presenting a significant challenge.
Furthermore, patient recruitment and retention pose growing challenges for a significant proportion of clinical development programs. Ensuring an adequate and diverse patient pool for clinical trials is challenging, requiring effective recruitment and engagement strategies to meet enrolment targets and maintain participant commitment.
As clinical development requires an interdisciplinary approach, coordinating efforts across various disciplines other than clinical, including regulatory affairs, pharmacovigilance, and medical affairs, requires effective communication and collaboration to maintain alignment with overall project goals.
Effectively addressing these challenges and achieving key milestones requires a strategic, adaptable, and collaborative approach, as evidenced by my experience in overseeing clinical development over the last 2 decades.
Q5. Your skills include recording procedures and interpreting results. Can you elaborate on the importance of meticulous documentation in the context of clinical research and its impact on decision-making and regulatory compliance?
Individuals engaged in clinical trials have likely encountered the adage, "if it's not written, it didn't happen." However, emphasizing the significance of meticulous documentation goes beyond this saying, as it is crucial to guarantee the precision and integrity of the gathered data.
Precise recording procedures contribute to the reliability of study outcomes, supporting the validity of results and the overall scientific credibility of the research.
Comprehensive documentation provides a transparent and detailed account of research procedures, interventions, and observations. This wealth of information facilitates informed decision-making throughout the research process, allowing investigators and stakeholders to assess progress, identify trends, and make necessary adjustments to the study protocol.
Detailed and accurate documentation also supports effective risk management. In the event of unexpected events or deviations from the study protocol, thorough documentation provides insights into the context, allowing for a comprehensive assessment of the impact on data quality and the study's overall integrity and patients’ safety.
Q6. Being multi-lingual in Greek, English, and French is a valuable asset. How have your language skills and your ability to communicate with diverse teams and stakeholders played a role in your ability to transform strategic ideas and visions into reality in your previous roles?
Although Proficiency in multiple languages enhances clear communication, ensuring that strategic ideas are conveyed accurately and comprehensively, i believe communication skills should go above language. When strategic objectives are communicated clearly and tailored to diverse audiences, it ensures a shared understanding. This alignment is crucial for unifying teams and stakeholders, promoting a cohesive effort toward achieving common goals.
Being involved in global projects and having daily interactions with people from around the globe i have managed to understand and respect diverse cultural nuances, by navigating through regional differences and building relationships based on mutual understanding. This adaptability ensures that global strategies are implemented with sensitivity to local contexts, contributing to the success of initiatives in diverse settings.