Clinical Affairs Program Management
- Global clinical strategy planning for regulatory clearance and post-market evidence claims, tailored for both long-term vision and short-term objectives.
- Crafting and refining clinical sections for FDA submissions, amendments, and annual reports.
- Aligning clinical endpoints with precise business value propositions.
- Developing comprehensive clinical timelines, roadmaps, and publication strategies.
- Fostering cross-functional collaboration among clinical, product development, and commercial teams.
- Designing and executing PMCF plans and reports.
- Facilitating internal and external peer review/validation of clinical methodology and strategy
The Challenge
The Challenge
The Challenge
An emerging business unit's portfolio included a device on the market with no direct clinical evidence, while an acquired device faced performance issues. The mission: construct a comprehensive clinical strategy plan harmonized with business goals to propel market adoption and advance the development of both devices. The clinical evidence essentially needed to be built from the ground up with novel studies.
The Work
The Challenge
The Challenge
To initiate strategic planning, I formed a core team comprising of functional leaders and subject matter experts (SMEs) to steer decisions and determine clinical evidence priorities.
A methodical yet creative approach guided the identification of clinical evidence priorities:
Brainstorming Sessions: I facilitated the team's brainstorming of current and proposed value propositions, product offerings, and published literature to determine potential endpoints and clinical studies.
Endpoint Ranking: The core team ranked endpoints in three categories – (A) critical to market development, (B) priority on the timeline, and (C) uniqueness/differentiating factors.
Results Analysis: A collaborative analysis of endpoint ranking was conducted providing a framework for the roadmap and timing of each potential study.
Study Roadmap Formulation: I crafted a comprehensive study roadmap to incorporate both devices individually and then collaboratively.
The Results
The Challenge
The Results
The culmination was a robust clinical strategy plan met with widespread acceptance and excitement. The plan included roadmaps for eight studies over four years, effectively addressing immediate needs while laying the foundation of clinical evidence and fostering the growth of both devices in the market.