Case studies
Coaching a Management team
Situation: The department was struggling with internal conflicts and communication breakdowns due to the team’s perception of their manager as overly directive. An earlier incident further escalated tensions, posing a risk of staff turnover and necessitating intervention.
Approach: A customized coaching program was designed and implemented, consisting of:
– Intake sessions with the manager and consultants to gather insights and refine the program’s objectives.
– A kick-off session to set expectations, followed by two follow-up sessions with the entire team focused on improving team dynamics, communication skills, and creating an action plans.
– Regular discussions with the manager and a final evaluation session to assess outcomes and establish strategies for sustaining improvements.
Outcome: The team coaching intervention resolved conflicts, improved communication, and empowered the team to independently manage challenges, resulting in a more collaborative and high-performing environment.
How long did it take: 3 months
Building a High-Performance Drug Development Team
Situation: The development of a new compound is executed by a global, cross-departmental, Drug Development Core Team. To ensure optimal cross-departmental collaboration and efficient decision-making, teams usually work in a so-called Core Team model. For this client, a relatively small Biotech organization, the concept of working in a Core team model was not yet established. The lack of alignment and communication between the departments resulted in inefficiencies, unclear decision-making and potential delays.
Approach: I established clear roles and responsibilities for each Core Team member, provided structured communication channels, clear collaboration guidelines and a clear decision-making process. I organized several workshops on how to improve communication, work accross cultures and to improve decision-making. I led the team through change to ensure that the new Core Team model was fully implemented as intended.
Outcome: The team established the new Core Team model and collaborated more efficiently.
How long did it take: 6 months
Improving global collaboration in Pharmacovigilance
Situation: The global pharmacovigilance department had sub-optimal processes and collaboration challenges in the global virtual team, resulting in inefficiencies and a potential risk for non-compliance.
Approach: I supported the Head of PV to implement the concept of working in virtual teams, to streamline communication and improve collaboration. I led efforts to identify several initiatives to optimize processes (for example Case Processing, Safety reporting, Meeting management and review of documents) and supported the execution of these initiatives.
Outcome: Improved operational excellence in the execution of the PV processes and more efficient collaboration accross regions.
How long did it take: 6 months
Leading a cross-departmental improvement project
Situation: Inefficiencies in cross-departmental communication and information sharing caused delays in implementing safety updates and label revisions in the final packaging materials.
Approach: I led the project to redesign the process by establishing improved communication channels between Pharmacovigilance, Regulatory Affairs, Artwork and Supply Chain.
Outcome: Reduced time for implementing relevant safety information in the product labels and artwork, resulting in improved compliance.
How long did it take: 10 months
Driving Process Harmonization in Regulatory Affairs
Situation: Fragmented regional processes in Regulatory Affairs led to operational inefficiencies
Approach: I led a global harmonization initiative to align regional practices with global standards and create a unified SOP framework.
Outcome: The total number SOPs were reduced by 25%, eliminating inconsistencies and improving operational efficiency.
How long did it take: 18 months
Establishing a Project Management Office (PMO)
Situation: The organization lacked a standardized approach for project prioritization, progress tracking, and resource allocation, leading to inefficiencies in aligning projects with business objectives. Additionally, there was a need to manage the Operational Excellence portfolio more strategically to maximize impact.
Approach: I established the Project Management Office (PMO), creating a standardized framework for project prioritization, progress tracking, and resource allocation. I developed guidelines and tools that allowed teams to manage projects more efficiently and ensure alignment with strategic objectives. Additionally, I took charge of the Operational Excellence portfolio by organizing workshops to generate and refine improvement ideas. I presented the portfolio to senior management, ensuring all projects aligned with company goals and objectives.
Outcome: The establishment of the PMO improved the organization’s ability to prioritize and manage projects effectively, leading to enhanced efficiency and resource optimization. The workshops generated actionable improvement initiatives, and the strategic alignment of the portfolio with company objectives ensured a clear focus on impactful projects.
How long did it take: 12 months
Leading Drug Development Projects
Situation: The development of a new compound is executed by a global, cross-departmental, Drug Development Core Team. The role of a Project Manager in a Drug Development Core Team is pivotal for ensuring that drug development projects are executed efficiently, on time, and within budget.
Approach: I supported the development of strategic drug development plans, including budget, timelines and resource requirements, and fascilitated creation/updating of business cases that are needed to obtain management approval. I was responsible for planning, coordinating, and overseeing all activities, ensuring cross-functional collaboration, managing risks, and communicating with stakeholders. Key tasks include resource and budget management, tracking timelines and milestones, ensuring regulatory compliance, and facilitating team meetings. I acted as the central point for project information, solving issues promptly to keep the project on track and aligned with objectives. At Pharming, I established strong collaboration guidelines and led the team through change to ensure that the new Core Team model was implemented.
Outcome: The projects progressed smoothly, with adherence to timelines and budgets.
How long did it take: Drug Development projects take multiple years to complete
Establishing a Clinical Operations team focused on achieving operational excellence
Situation: The Clinical Operations department needed to enhance efficiency across various critical areas, including patient recruitment, clinical trial data management, resource utilization, and performance tracking. There was a pressing need to implement a structured approach to manage resources effectively, ensure compliance, and reduce operational costs.
Approach: I implemented a comprehensive collaboration model that improved resource utilization and reduced costs for clinical studies by promoting better communication and cooperation between teams and sites. Additionally, I designed a capacity planning model to accurately forecast resource demand, enhancing decision-making related to country selection and resource allocation. To ensure high standards and efficient trial execution, I also established standard KPIs for clinical trials, improving performance tracking and regulatory compliance. Other key actions included optimizing patient recruitment processes, improving clinical trial data disclosure systems, establishing document quality control measures, ensuring inspection readiness, and developing SOPs and training programs.
Outcome: The collaboration model led to a reduction in operational costs for clinical studies and improved resource utilization. The capacity planning model provided accurate demand forecasting, resulting in optimized country selection and resource allocation. The introduction of KPIs enhanced performance tracking, supporting efficient trial execution and ensuring adherence to regulatory standards.
How long did it take: 24 months