Clinical Trials & Surveys Corp, C-TASC, of Owings Mills, MD, recently announced that Jose Gallo (pictured) has joined the clinical trials solution company as senior director of biometrics consulting. Over a 23-year career, he has worked as a statistical consultant and counseled clients on submissions to the FDA and European Medicines Agency. He was director for biometrics at Therakos, a Johnson & Johnson company, where he developed and led a biometrics department. Here he shares his going-in thoughts on the new job.
FierceBiotech IT: For people who aspire to a position like yours, what's the top thing they need to know but are probably unaware of?
Gallo: You need a strong mathematical and scientific inclination, of course, as well as an understanding of the key tasks that biopharma companies face in their NDA submissions and related work. You need to understand what the regulatory agencies expect. Strong leadership abilities are also essential.
But even with this knowledge, you still need people skills to be effective. This work requires you to interact with many people across many different disciplines. You have to be able to interact well with people and know how to communicate clearly and effectively.
Your new job title is senior director for biometrics consulting. Will you do more directing or consulting?
It will be 50-50, though I'll probably do more directing initially as I establish procedures that enhance our support of biopharma companies. But I'll also be increasing my consulting responsibilities. I don't believe you can lead if you're not in the trenches getting a good understanding of the challenges involved
In a typical week, what percentage of your time do you expect to spend on the following?
- Working alone: 15%
- Working with company colleagues: 20%
- Working with customers: 65%
What tops your to-do list as you start this job?
I'll develop a presentation that outlines how C-TASC can provide biopharma companies the support they need for their drug submission clinical trial responsibilities and post-submission tasks. I'm beginning work to enhance the support that C-TASC already provides its biopharma clients.
What do you love about your work?
C-TASC provides a friendly environment and the people are focused on producing a top-of-the-line product. They spend time thinking of how they can improve and be creative in their work. The company's focus on ensuring the integrity of data and considering solution options is very much what sponsor companies need in a CRO. I know this well. I am at a place that can positively impact the success of our clients.
What will be different about C-TASC after you've been in this position for a year?
The number of biopharma clients will have increased significantly. And the already effective group, its resources, and its procedures for consulting with biopharma companies will be enhanced.