Stephen Smith

In this interview, I had the pleasure of speaking with Stephen Smith regarding clinical program management.

Stephen has several years of project management experience in the healthcare industry.

His experience isn’t limited to clinical project management.

Stephen has served as senior program management director where he was the glue between R&D, marketing, clinical, and manufacturing teams for rare disease and oncology drugs.

Stephen shares his experience working for top-notch organizations such as Genentech, Gilead Sciences, Audentes Therapeutics, and more.

Since the time we recorded this interview, Stephen has changed employers. However, our discussion of challenges with clinical trials for rare diseases, the process for career development, and the importance of lifelong learning still hold true.

In this interview, Stephen and I discuss why communicating clearly is important and how being humble and calm can make you a super-star.

There is a wealth of information on people skills that all of us need to hone and develop in order to accelerate our clinical research career.

Please join me in welcoming the all-amazing Stephen Smith to the Clinical Trial Podcast.

Show notes:

  • What is Gene Therapy?
  • FDA involvement in gene therapy trials
  • Responsibilities of a senior project manager from research to commercialization and beyond
  • Key to success: being a generalist, learning new things and clear communication
  • Making use of opportunities and resources to overcome technical challenges
    • Having an open honest dialogue with the manager will help to grow in career
  • Managing a team as a beginner
  • Handling negotiations as “WIN-WIN” situation but not as a “CONFLICT”
  • Challenges when working in rare disease clinical research
  • Difficulties to locate a rare disease patient
  • Role of patient registries in identifying rare disease patients
  • Everything from research all the way to commercial planning and its impact on the program
  • How conversations and explanations with the team help to have a clear idea of the project
  • A clear regulatory pathway helps in having a clear clinical development plan
  • Short time horizons, short term goals help to beat the timelines
  • As a manager, allowing space for coworkers, to discuss the things they need to move forward in their job

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