Beyond The Protocol

From Pipeline to Patient: Humanizing Business Development in Clinical Trials

• Melody Keel • Season 1 • Episode 8

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In this episode, Senior Director of Business Development Karen Harris joins Melody Keel to share how her two decades in clinical research—and her personal connection to rare disease—have shaped a career rooted in empathy, strategy, and purpose.

Karen breaks down what it means to lead with intention in the high-stakes world of clinical trials. From navigating complex sponsor partnerships to staying grounded in the “why” behind the work, this conversation is a must-listen for anyone working at the intersection of people, process, and patient impact.

What You’ll Learn:

  • How business development can be a clinical trial success driver—not just a sales function
  • Strategies for navigating complexity and alignment in modern trial ecosystems
  • Why personal connection can fuel leadership and deepen partnerships
  • Ways to lead with empathy while meeting demanding sponsor expectations
  • Advice for new leaders building careers in clinical research
     
     

Whether you're building sponsor relationships, leading through complexity, or searching for deeper meaning in your work—this episode offers real-world insights and human-centered strategies to lead with clarity, empathy, and purpose when it matters most.

Welcome to Beyond the Protocol—where authentic conversations about clinical research happen.

Hosted by Melody Keel, bringing together diverse professionals from across the industry to share insights and experiences about what it really takes to deliver successful clinical trials.

This isn't about perfect processes—it's about real people sharing real solutions.

Let's go beyond the protocol.

That's all for today's episode of Beyond the Protocol—where we explore what it truly takes to deliver successful clinical trials. 

If you found value in today's conversation, please subscribe, share with your network, and leave a review. 

Have experiences or insights to share? Reach out and be part of the conversation.

Join us next week as we continue to discover what lies beyond the protocol.

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This Podcast is Sponsored by The Research Associate Group, Inc.

Melody: All right. Welcome back to Beyond the Protocol. We're on episode number eight and I'm so excited to have my guest today, Karen Harris. And we are going to jump into the side of things that many of us in operations may not even consider, but I have the fortune of No way it pretty well because Karen and I are dear friends as well as industry colleagues, and that's business development.

So welcome, Karen. I'm so happy to have you join us for episode number eight. 

Karen: Thank you for having me. It's definitely an honor. I, we go way back and I just appreciate someone taking an opportunity to explore business development because I think it's probably one of the most important aspects and the clinical trial process.

Melody: I agree. I do agree, and honestly, I may not have understood that as well if I didn't have. You and the conversations we've had and the insight you've given me into how important what you do and the business dev development side of things. What a role that can play in the success of the partnerships we have with the vendors and the companies we work with to get the trials to the finish line.

So I'm thrilled to have this conversation today, and I right in. And you tell us about your journey into clinical research, because many of us have a twist and turn just all in way to get in. And I love your story, I want everyone to hear about it. 

Karen: Definitely an interesting story and I look back, over the 20 years that I've been doing this and I have come to realize that it takes every step of the journey to get to where we are today.

We need to look back and we need to look at things that might happen in our life and along our professional career as a positive opportunity. And that's, I tell that to my kids every day look at what's happening and take it as a positive. It's gonna grow from whatever's happening in that moment.

So my career, I actually started, I graduated with an exercise physiology degree. I did cardiac rehab as an internship. Loved every aspect of that, but then realized probably a year in it wasn't a lot of money in it and it's do I go back to school and get my master's or do it? Do I step out of my comfort zone and get into a sales role?

So I became a recruiter, which I had never heard of. Even recruiting. I found a job online started recruiting and actually it was like recruiting warehouse workers. So I actually had. I learned how important even an $8 an hour warehouse worker was, at that time. And how everyone who goes to work every day is part of the puzzle and part of the bigger pro project.

And it 

Melody: everyone is important no matter what your role is. 

Karen: Correct. And that really, I think, probably humbled me first and foremost to realize that. And I became friends with a lot of the people that I was put into work. And then from there I was doing so well. I really loved science, so I had the opportunity to move over and recruit and this scientific side of things.

And from there, I was working on pharmaceutical positions. CRAs project managers had no idea about the whole clinical trial process or even who was part of that. So that was eye-opening for me to learn each of those jobs. And then from a recruiting role, I had an opportunity to move into a business development role with the CRO that I started working with 10 years ago.

They had hired me to be one of the first ones to come in and sell staffing services in the US and there was some struggles there and they said, Hey, I think that you might be better in business development. What do you think? I was like, I would love that. And so that opened another door for me 10 years ago.

And just to be able to work now with the studies and learn more about the protocol and the research that's going on, but also now seeing all of those crass, those project managers, those data managers, those biostatisticians that I put to work now, actually seeing them in the clinical, study was very.

It would just like the, it came full circle for me. And so I've been in business development now for the last 10 years and have loved every minute of it. 

Melody: And I feel that when we talk about things and even when we are together for non-business reasons, we always somehow come back over to our industry and what's going on and the challenges and the things, and I'm always in awe of how passionate you are about the relationship building and partnership and the collaboration and what a critical role that plays in the successful outcome of a company a sponsor that's doing research, how that can make or break them by choosing the right partners. And you really seem to be able to navigate that well.

Karen: I think it just comes down to being able to connect with people. I love people, I love science. I love research. I love my job. And so is it really a job if you love it? I've, it's my passion and I wake up every morning and I get to do something that I love and learn about new studies, learn about new opportunities, learn about new drugs, and that's exciting.

But also, I have been able to see it personally benefit my family, in some regards. And so that has also been, a touching moment. It's that aha moment where you're like. I am doing something that's making a difference for someone, even when you don't necessarily see it every single day.

They have it moments along the way, and that to me is what's more special. 

Melody: I agree. I agree. So let's talk about business development. I'm always I don't know. I look at sales just isn't part of my, it's not part of my ministry. I feel like that's just, I always say this is just not my thing.

Yet my brother who is my twin, he's awesome at it. Like we tease him and say he can sell water to the ocean. I think it's just an innate gift and I realize the people that are really good at it also are really good at relationships and. Having conversations with people, strangers, people they know, they don't know all of that.

So tell me about business development and what that is. For those of us that aren't very close to it and don't understand it, it's not just sales, it really is partnerships and collaboration. I would love to understand your view of it and how it aligns with operations and clinical trials.

Karen: I will be the first to tell people I am not a salesperson. Do not hire me if you think that I'm a make a hundred cold calls today, because I am not that person. I can build a relationship, give me an opportunity to meet someone new. I can build that relationship and I look back over my career, melody and I, what I'm doing today.

In business development. I am also still making connections from those connections that I had 20 years ago when I first started recruiting in these positions. And, people get, better positions, they improve, they go from a CRA to the project manager to A CTM. They become director of clinical operations.

They become VP of clinical. They become a CEO that starts a new biotech company. And so that's where I pride myself and on those relationships that I have built. I just, I don't know, I guess I have a calling in life to be able to connect, to be able to relate, to be able to listen, and to be able to learn to in business development.

I think that it. It's so important because it's my job to go out and to meet with sponsors, to meet with pharma companies, biotech, medical device companies, see what type of new studies they have coming down the pipeline, continue to speak with them, establish relationship that, Hey, our CROI work forever as clinical research.

We've been in this industry for 21 years. We know how to do these studies. We've been doing this excelling. Give us an opportunity. And so just saying, staying along the side of them, each step of the way it, the sales process can be six to 12 months that it takes for, funding to happen for these studies and the protocol to get approved.

And then when it's like, Hey, we're ready to send you over an rrp. It could be a year from now, it could be a year and a half from now. But staying in touch and building that relationship is where you bridge the gap from the early start of. A client working on a protocol to the time that they're ready to bring the RFP over to cro.

Melody: I agree. And I think having the opportunity from the sponsor side to be part of the RFP process and selecting the vendors that will come in and partner with us to run trials the business development team really is the difference maker and who your contact is and who you're working with. I've had some incredible partnerships with the business development person of that CRO or of that vendor, and they are able to see downstream and help us through our lifecycle.

And they almost anticipate what we need. So I feel like it's not so much them positioning themselves to make sure business continues, but really helping us to be successful and understand what's coming and how their organization can help us. Downstream. And so I think sometimes we overlook that in the process.

So I'd love to understand what in missteps from sponsors and biotechs when they're going out and doing the vendor selection process and the RFP and what they're focusing on. What do you wish we as sponsors would do better when we're doing site selection? And what are some of the missteps that you see?

Karen: There's so many caveats into choosing A CRO and what, who's gonna be the perfect CRO? There's so many CROs out there, but I think that you've gotta look at what is your study? What are you trying to attain? Most of the time, you've got a client who wants to have a CRO that's got the experience in that industry or in that particular indication, so that's where they're gonna start.

Sponsors out there are not looking for a new CRO unless they're having some issues. Why change something that's working? So that's where my job is are some of these early conversations, just build that, build the relationship, but also to build that trust and get them to be able to tell me some of the concerns that they're having and see if it's even something that I could potentially overcome for them, and if we can do it better.

And I will say, the opportunity that I've been given now here at Everest, they didn't have business development for 20 years. So I got a phone call from a recruiter, wanting to talk to me. 'cause I had been in a role for eight years, seven and a half years. And that's not the norm either.

A lot of people job hot, but I'm very passionate and loved what I was doing. It was intriguing to hear a company didn't have a business development for 20 years had been very successful, and now see the need of bringing in that business development person. So that's my goal is to get in there and to start having these conversations very early on and just to see what the pain points are and how could we do things better for them and help them along the way and go back to my team and say, Hey, this is what's happening.

This is some of their issues. How would we do it differently? And then going back to the client and saying, Hey, this might be something you look at. I give out a lot of free advice along the way. Me, you know it. I wanna help people. So even if it doesn't come back to me, as long as I can give some advice and guidance, I feel like I've done my job in the development.

Of course, I want every single RFP to come across my death, and I wanna to be awarded. It doesn't happen, and I look at that as an opportunity to step back and say, Hey, we weren't the right partner, or it just wasn't the right timing at this moment. 

Melody: A lot of times it's timing for sure. Yeah. That's great insight.

So where do you see business development going? We're in an unprecedented time. I just this week. This morning we just had an episode about that on beyond the protocol about the times that we're in and the unknowns. So I would love to get some insight for you from you in terms of how our business development roles evolving when you have decentralized trials.

We have AI coming in. I'm guessing relationship building is still the foundation of everything, but I'd love to hear. Your thoughts about that? 

Karen: There's been a lot of buzz words in clinical research along the years of remote based monitoring. We heard that for a really long time and it didn't really happen until we had covid, then everybody had to pivot fun. How are we gonna do this remote, remote based monitoring that we've been talking about? Even in like decentralized trials, as a CRO, I think we need to be adaptive to the changing landscape of clinical research. It's not gonna stay constant and you shouldn't want it to because research should be evolving things forward.

We can't fit everything into one size. So I think therefore we've gotta be able to bring other opportunities to the table and be open to those conversations. And I know that's something that first and foremost. Here at Everest to see what is out there, what's new what's up and coming. Let's make sure we're on top of any of the changing things in the industry or the standards that might be coming down the road.

Melody: I agree. I agree. Do you feel like right now in the present time, this snapshot? I feel quite a bit adjusting happening. Quietly, but in anticipation of trying to prepare for it what's down the road, even though we don't know what that looks like yet. So do you feel like there's some messaging coming across right now to you as a business development partner about projects coming downstream and cleanse or changing what's not being said?

What's unspoken right now for you from a business development? 

Karen: I think, as you mentioned a while ago, like with decentralized trials. Years ago, everybody went to the site. All of the patients showed up at the site. You had to get them to the site. We were losing subjects. You, how could you be diverse and how could you get the right population if everyone had to come to the same site at the same time?

So I think as opening up, the opportunities to bring nurses to the home of the patient. I think that's something that's very forward thinking and we are starting to see that more and more in some of these STU studies, especially like with rare disease. Sometimes the patients can't leave the house, sometimes they don't have the transportation that they need to be.

Being able to bring in the home health nurses to go out and pull those labs and to do, those checks on them. That's where I think that things are continuing to evolve and that to me is very exciting. We can't fit a round peg into a square hole. We just, we can't. And so that's where I feel, research has come a long way and always being adaptive and now we see that shift to how can we make things better for the subject and that patient to get them in this study.

Yeah. Agree. Agree. 

Melody: And so I think that's a great segue into, research being personal, and I know both of us have had experiences in, in, in situations with loved ones where clinical trials have impacted us, not just on a, the research that's being done has impacted us, not just on the professional side, but we it's been part of our lives personally too.

So I'd love to hear what that means for you, from your guy, what your has. 

Karen: We all have that thing, that time in life where it's like nothing's gonna happen to us. My son choked on food one night and we just saw he choked on food. And come to find out after, fur of testing that he was, he was diagnosed with a rare disease.

It's called eoe. And my kids even laugh at me when I say the word all the time, but it's eosinophilic. It's. It is a rare disease, but unfortunately I think it's becoming more common. When he was diagnosed at 12, he just turned 18. A few days ago, there weren't a lot of approved drugs, so it was, Hey, let's try this inhaled steroid.

We've seen this work. Let's do, let's take some food allergies out. Let's start with your basic, milk, egg, dairy. We did all of that, and he went through three scopes in the matter of. Four or five months and we still didn't have any type of remission. So fast forward, a few years he called me again from school after just some struggles and he like, mom, I cannot breathe.

I felt like he was gonna choke to death. And it was at that moment that I was like, we've gotta do something different. Go back to the pediatric gi and she just said, I think it's time. They finally just approved. Probably six months before this episode for eoe. Dupixent had been around for a while, but again, because of the clinical research and the studies that had been done on Dupixent and the follow up, they started seeing the Dupixent, was great for atopic derm.

Then it was great for asthma patients, and then it became approved for EEO e just recently. They're talking about it, being approved for COPD, research is evolving where they're continuing to look at other indications that a drug may help. We had to take that chance and say, let's give it a ch, let's give it a try.

And it's very hard to look at your son who is 15 at the time and say you're gonna do this weekly injection, the biologic injection. But it's probably one of the safest that was on there. And because of my research brain. I asked every doctor that I could read every single thing that I could in clinical trials.gov, and we finally took a chance and within three months he was already able to tell a difference.

He could eat, he could swallow. We started seeing that he was able to gain weight, and we did a scope at six months after the depiction started for the first time and three or four years he was in remission that he did, he just sent a, he just took his hundred 18th injection this past Monday.

And he is flourishing. He's gaining weight. He's been on 25 pounds this past year. He is doing very well in life. So to me, I can see the passion of clinical research is now been such a positive experience for my family, that I hope and pray that we can continue to do this for all of. Rare could be or other, 

Melody: when we say patient birth and research matters that's why like the story with your son and the experience and that's what so many of us that's a similar story for so many of us and we wouldn't have, I think that's what we sometimes just forget if we didn't do this, what you and I do in so many.

Everyone that's in the industry that gives so much to be part of it. That's what it means so that there's a therapy, there's a, there's an option available, especially for those when it seems like there is no option. And then now suddenly there is, and it gives an outcome that we, that's good. That's why we're here.

And so when people are like, oh, you're so passionate about it. I think most of us are when you really start to dig in because we understand that's what we're doing it for. That's our why. Absolutely. Yeah. I love that you share that. I appreciate that and I think it helps us to remember that and all the metrics and all that's protocol trials and all the pieces that we focus on that we.

Do not forget our why, and that there are humans at the end of this. There are hues that we're doing this work and we have to keep that front of mind every day, not just, when we hear a podcast or we see a story, we have to remember it every day. For sure. 

Karen: Absolutely. 

Melody: So I think I would love to just wrap up and have you share

some wisdom. To those in leadership positions that are responsible for choosing vendors and working with business development partners and CROs and patient recruitment companies and all the wonderful companies out here that support the journey, the mission what would be your words as we close out to them?

As, because they're in heavy places and in, in terms of responsibilities to make sure. Who gets bought in to partner with us is the right fit. It's the right partner. It works for so many different reasons, from so many different perspectives. So what would you share from your side to them? 

Karen: It, that's our job is connecting all of the dots, finding the right partner for the right study to be able to get this through each phase of the program.

You've gotta be a little empathetic along the way. I think in order to foster some of the trust, you're trusting these vendors to do your study. I think you've gotta do your homework. That's kind of part of my job in business development and I probably do a little more than most people.

I go out, I help find, if we've got a page one study, I'm gonna go out and do some research and find a study that's done some similar. Indication and see what sites are out there and talk to those sites and say, Hey how were those sites enrolling? And finding that right partnership for each study.

You've gotta do a little bit of extra of that leg work. And I think that's where business development comes in. And that's part of my job and I've taken that on. And again, it might not be what maybe BD people do, but I'm passionate, so I wanna be involved as much as possible. But I think that leaders just need to be very empathetic and once we're empathetic, that allows people to trust us.

And then once you've got the trust, that's gonna help get people to buy in, that's gonna help get them engaged. And that's gonna allow it to be able to create, a better supportive work environment. And if everyone that's working on that study together is doing their job, we're going to be able to meet those timelines because at the end of the day, we've gotta meet timelines for a sponsor.

Meeting those timelines is just as important as being able to get that quality data at the end of it. So if everyone has, bought into the importance of this study and what our why is, we're gonna be able to get that data at the end of the study for that client and for that time. 

Melody: Agree. And I think moving away from the one size fits all would benefit us all so much.

I. 

Karen: Ooh. And I, powerful. And I'm a business fellow. We're not, we might not be the best fit for you, and I need to see what it is you're looking for and see if we can accommodate that. And there's been times, melody that I've had to say, we're not the best fit for you. I, and I think we're not the best fit because we haven't done X, Y, or z.

Typically Melody, they wanna come back and they'll say that's why I want to work with you because you are so transparent and you are so honest. And I and I appreciate that. And I will be honest, that probably helps me down the road. I continue to foster that relationship. They may have another study that might be a good fit for us, or that person might lead that company and go to a different company and then they come back.

So I think that it's just honesty and transparency also goes a long way in our industry and in order for me to still be sitting here 20 years later and being successful in what I'm doing, it's because I've been honest with people. Yeah. 

Melody: Yeah. I think that is an incredible value no matter where we are, but especially in this industry.

It just keeps the cycle and the relationship going, and so 

Karen: I love that. And I actually will add, I look back, as I mentioned earlier, I've, I'm working with some of the same people that I was recruiting 20 years ago. And to be able to see that kind of come full circle it's exciting. I tell people I'm here for the long haul in business development.

I'm not a sales person because salesperson here, just to get a, the. I'm here for the long haul and I tell people all the time, if I don't win this first project, doesn't mean that I'm gonna go away. 

Melody: Yeah, I'll be back. You be married to me

Karen: when I've made probably 10 phone calls in and I've sent 15 follow up emails, and I finally get a response back that says, you have continued to stay in touch and I at least have to give you a response. We don't have anything, but when I do, I will reach out to you. This is 

Melody: everything I do.

Persistence. I love it. I love it. Thank you Karen. I appreciate you for joining us. I think this was really insightful for people to understand the business development side of things and what that looks like and how it plays such a important part to.

Companies that are with us to get to the finish line. 

Karen: Wow. Thank you for having me. It's been great. I, as I said, I'm always excited to talk about business development and just how I feel It's an important role and, clinical research today. So thank you for this amazing platform that you've got going on.

I've enjoyed listening to all the podcast and just all of the amazing messages that have been delivered on a, through these episodes. So thank you for educating us all. Yeah. Thank 

Melody: you. Thank you. All right. We'll see everyone again on the next show. Take care. 

Karen: All right. Thank you.

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