Project- and Program Management

In Biotech and Pharma almost every item of the value chain is managed as a project, so it is natural that Project Management (PM) is a major success factor and makes a huge business impact in drug development.
PM ensures operational effectiveness through overarching development planning (CMC, pre-clinical, clinical, regulatory) and efficient execution, delivers value through robust risk management and increasing the probability of success, and ensures transparency for all stakeholders. A transparent development strategy and strong Project Management are the major prerequisites to ensure strategic and operational alignment across all disciplines. Team leadership and communication skills are key success factors in PM.

A set of projects that follow the same strategic goal are managed as a program. In drug development this is usually the management of an asset or an asset class. Program Management techniques are designed to avoid attrition at internal and external interfaces, to better identify and mitigate risks that affect multiple components of a program, and to streamline communication to stakeholders.

Typical PM tasks are to lead and oversee the

• Preparation of an overarching asset development strategy.
• Scenario planning to optimize and accelerate development.
• Definition of the Target Product Profile.
• Preparation of functional project plans for all disciplines.
• Planning, tracking and reporting of timeline, budget and quality.
• Planning of and participating in regulatory authority meetings.
• Change Management.

I will provide professional PM services in close collaboration with your development team, by assuming the role of a Project Manager and/or the development and implementation of Project Management processes and tools.