Beyond The Protocol

How Do You Turn Training into a Leadership Pipeline?

• Melody Keel • Season 2 • Episode 6

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What if your training programs didn’t just meet compliance—but built your next generation of leaders?

In this episode, Melody Keel sits down with Celeste Brantolino, Senior Director at Exela Pharma Sciences and a 2025 Top 10 OnCon Learning & Development Professional, to explore how pharma and clinical organizations can transform training into a powerful leadership pipeline. 

Drawing from her success leading scalable development programs and integrating AI-powered learning across operations, Celeste shares how smart L&D strategy drives real business impact.

In this episode, you’ll learn:

  • How competency-based training can drive measurable promotion and performance outcomes
  • What it takes to scale leadership development in GMP-regulated, cross-functional environments
  • How immersive tech (AI/VR) is transforming onboarding and clinical readiness
  • Why tying learning to culture, feedback loops, and operational systems is key to long-term success

If you're navigating high turnover, readiness gaps, or building internal talent pipelines, this conversation delivers the blueprint clinical ops leaders have been looking for.

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 Keel: Welcome to Beyond the Protocol. I'm so excited to have you here, but even more excited today to have my guest. Celeste Olino on with us who I've had the pleasure of meeting again through LinkedIn. And I must admit, I think I was a little star struck after our first meeting because training is like, is one of my pain points, topics, things that I really, really, really am passionate about.

And so to find someone who's made a career out of. Learning and development in the corporate environment and has just done some incredible things at organizations. Yeah, I'm all for this. So welcome Celeste. I'm so glad to have you here. 

Celeste Brantolino: Well, thank you and I'm thrilled to be here and like you, I felt like we were kindred spirits.

Um, it's. Refreshing to find someone who works in clinical ops, who truly understands the value of a foundational l and d program and how it can be used as a leverage to bring your clinical ops program, um, not just to a, a level of compliance, but you know, to a really high performing level that rewards people, you know, um.

I think what clinical ops does is so important and it it sometimes I don't think we always nurture our own development as much as we should. 

Melody Keel: Agree. Agree. And I love the idea or the concept, that it's not just checking a box, right? We're not just reviewing SOPs to say we did it or to kind of have some reference point of how we should work, um, in a standardized way.

But it's a way to truly help you develop and grow and, and move into different roles and, and even into leadership eventually. So this isn't just developing talent. Right now we're developing future leaders who know how to operationalize and work in a high quality way. 

Celeste Brantolino: Absolutely. And lead others to do that out.

You know, you, you wanna have that multiplier effect when, when you start to invest in people that they start to invest in other people and those people invest. 

Melody Keel: Yeah. And then it just starts to touch every. Faucet of your organization. Yeah. In a very good way. Right? Yeah. So that's, that's, that's what we're here today to talk about, and I would love for you to share with us your journey and how you got into l and d and, and where you are today.

Celeste Brantolino: Well, sure. So I have worked in learning and development for. A little over 20, almost 25 years. Um, I started out as an instructional designer, um, for American Power Conversion, and we were on the launch team for Data Center University. That was really back in kind of the early, early days of e-learning. Um, so that's where I, I learned my craft.

My, my bachelor's degree was in education. I had taught at a university. I, I always loved learning. I worked on a lot of projects for, um, the. Orientation leaders, and I was always brought in for presentations on how to develop emerging leaders. So I think that's kind of where my journey started. And then I strategically tried to round out things to move into corporate learning.

So then I started as an instructional designer at American Power Conversion. Um. Became a senior instructional designer with, um, Shiner Electric when they acquired a PC. Um, then I moved on to be a training manager in, um, for Tyson, um, which is the first letter of the FDA. Right? So it's the Food and Drug Administration.

So that began my, my journey down regulatory compliance. Um. And I worked for Del Monte. I've worked for Compact Tamra. I've owned my own consulting firm and went and helped turn around troubled training programs. Um, and then most recently I'm with Acela Pharma Sciences as the senior Director of learning and development and really help them build a foundational learning and development program, training program, um, that, that.

Drove excellence, uh, in their operations. But I also launched a three-tiered leadership development program. I'm really fortunate that the executive team at Acela understands that it's, it's important to have that technical expertise, but you have to have those soft skills, and that's what makes a well-rounded.

High performing individual and, you know, in, in the clinical area in pharma manufacturing, you know, the technical can't be overstated. We need people who can execute flawlessly because the stakes are very high. Um, and it's, it's, it's costly to make mistakes. We, we need to do things right the first time. Um.

But we, we have a mission to make safe, peer and effective medicine. Um, and we also need to be able to lead people effectively. Um, what we do can be stressful. So we need people who have high IQs as well as people who have high EQs, right? 

Melody Keel: Yes. So I, I wanna just sh immediately the light bulb went off when you were sharing that, and I thought your current, um, company is in GMP, your manufacturing.

Right. Um, and so I can so envision many of my colleagues on my side of things in the clinical space operations. Saying, well, that's a very different environment. So their training would be the requirement and what's needed would look different than what we required on the GCT side of things. And I would dispute that.

I don't agree with that. I think the same level of intentionality and um. Planning and strategy for learning and development and making sure the teams on the GMP side, the, or the, the humans that you work with, to make sure they work in a very standardized and high quality way that a hundred percent translate over to our clinical operations teams.

Celeste Brantolino: Yeah, I, I think I agree with you because. For manufacturing to be successful, we need consistency, repeatability, and quality. And to me, those, those things also translate into a lab environment, into a clinical environment. Um, you know. Running an HPLC, you have to have the technical knowledge. You, you have to have a standard protocol, right?

That you have to execute the same way each time. You're not free styling it, you're not saying, well, I know it says we should do this, but I really feel like we should do this. That doesn't happen in pharma. You know, it's a recipe. Um, it is a protocol. We follow 

Melody Keel: that. Agree. Agree. And I think that's a great lead in to kind of talking about why some training programs, if they even exist.

Because I've been in organizations where there is no training program, there is no development. When team, when someone starts at a company. Uh, onboarding is just, um, sign these papers, meet some people, here's our SOPs, um, and then we're throwing you in the deep end with the team and figure it out. And that's not a training program.

So I would love to have your perspective. What makes a training program successful? Whether you have one and you need to revamp it or you have nothing and you need to get one in place. What, what are kind of the, the top recipe items? That would make a training program successful. 

Celeste Brantolino: I think the first thing that that I do when I go in to any organization is I conduct a pretty thorough needs assessment, trying to get a baseline of what are they doing, what are they doing well, and what needs to be improved and.

Where are the gaps? What are they not doing? So a lot of companies, especially if they're, they're small, um, companies that are, you know, less than 500 employees, less than a hundred employees, they don't have a formal training program. Um, they, they do what I would. Probably best described as an apprenticeship.

You know, they'll have an SOP, you'll sign the, for the SOP that you've read it, and then they'll pair you with someone who will kind of guide from the side and, and that works if you are really small and your growth is slow and strategic hidden. It doesn't work very well when you land a big contract or you land a big piece of business and now you have to scale up.

Um, and you went from hiring one person, you know, every six months to every year to, Hey, we've gotta figure out how to onboard 20 people. Um. The the one-to-one, I'm gonna walk you through everything and, and bring you along very slowly. Does not work that way. So then you're going to have to have a more structured training program, um, virtually that begins with making sure that in addition to your master training plan.

And you've identified what your standard operating procedures are, but you may need to have standardized work instructions. Um, you will also have to have trainers that are very good at knowledge transfer. Not every, what I would call expert worker or strong technical person. And train. That is a whole other skillset.

Sometimes the best operator is the absolute worst trainer. Trainer. Yes. They, they, they cannot break it down for that new person. Um, I, I will see some of those great operators just look at the news person and be like, just do it. I'm like that, that is not helpful instruction. You know, um, the, the other kind of challenge that I see with companies that don't.

Embrace a foundational l and d or training program is they think telling is training that they'll, they'll hurt everyone into a conference room or they'll do a standup meeting and they'll quickly run through what the processes and they'll say, okay, everybody understand? Okay, good. Alright, let's go. Go team.

And. Then they're bewildered as to why they've got deviations or they've got people who are struggling or people who just leave. You know, journals are, is a huge expense, um, in, in any company, done all that work to find that best fit employee that we're giving them the training. To be successful and we are developing them.

Melody Keel: Yes. Yes. And the recipe that you just gave, um, I was thinking and applying it to operations and clinical trials and, you know, bringing everyone in to a room and saying, this is how you do it. Now. Go do it is exactly what we do. Internally with our study teams, we give a protocol, we'll have a training. The medical team will show us, tell us what to do on the protocol.

We document that as training, and then we have to go, and then we go out to the sites and we do initiation visits. We're basically, they're stuck in a room for six, eight hours with us, right? And we just go over everything with a slide set and say, okay, now you go. And it's just repeated in one way. After another.

And then we wonder why we have deviations, uh, study drug that's not monitored properly or managed properly, or patients that don't know how to follow the assessments and what we need them to do when they leave the clinic. So I think I, I just realized that l and B is not just within our organization, right?

It goes out to our vendors and our sites and our patients. And so what is our formal standardized training? That we deploy, not just internally, but externally too. 

Celeste Brantolino: Right, right. 

Melody Keel: I like 

Celeste Brantolino: to apply the, uh, see one, do one, teach, one model of training. You know, where they're gonna watch someone execute a task.

Then they're going to practice executing that task until they. Derive some level of proficiency and they state that they are comfortable. Yeah. And then to make sure that they truly understand it, then they teach back to their trainer. Because if you can teach something, you understand it. Right. You've mastered it.

Mm-hmm. 

Melody Keel: Yeah, I agree. And I think, um. I think that requires a complete mixup mashup of the way we consider trading, because that also is going to require a change in how we invest, because oftentimes there's no budget really, except for an investigator meeting or the, the SIV visits that that's the only budget we really have in terms of training.

Um, and then I, I never see like a. A budget, a line item for a study level for when new team members come in or there's turnover. How do we manage that at our vendors and our CRO partners? Um, there's not really a stated investment for this. Right. So then we're just kind of, it's just a afterthought when nobody goes to, no investment comes to it, it's just an afterthought.

Celeste Brantolino: Right, right. Um, so it's really important. To plan to be successful, and it's really important to meet with those key stakeholders. You know, people from a finance area when you're building your budget, and make the strong case and make that case in a way where you are explaining the the cost of not doing it right.

Here's the cost of doing it correctly. Here is the cost of failing to do it correctly. Yes. So I had an old boss that once said, spend it now or spend it later. We can. We can spend it smartly or we can spend it very unwisely. Which path do we wanna take? 

Melody Keel: And the unwise path is always greater than the strategic upfront path.

You spend so much more fixing what was wrong when you could have just started out the right way. Right? So I love the idea or the concept, um, that training can be used as a leverage, right? Um, to develop leaders and for people to understand that if I learn this in a very, um, strategic documented way that shows I understand.

And, um, I'm, I'm becoming efficient and an expert at this. I can be promoted, I can be developed and rewarded for my knowledge, um, and the time and energy I invest as an employee or a consultant or a vendor or a site. Um, I'm applying this in my world as we go along. Um, I can be rewarded for that. I would love to hear about the program that you created and, and rolled out in your organization that leveraged training in this way.

Celeste Brantolino: So, are you talking about my three tier leadership program? Yes. Mm-hmm. Okay. I just wanna make sure. Yeah. So, um, about three years ago. I started the leadership series and at the very base level it's the the LEAP program, and that's the Leadership Excellence Acceleration program. They, it's a year long program.

They meet once a quarter. It's a hybrid approach, so they. Receive some online learning modules that are designed to give them a foundation in leadership principles. Um, understanding what good leadership looks like. Um, there are books that they're going to read and then we meet for a couple of hours once a quarter, and we do exercises as a group that are designed to kind of.

Tie together all of the assignments that they'd done through the LMS, the reading that they'd done, and the courses that they've taken. And what I have found is there's a lot of aha moments, what they thought leadership was and what leadership actually is, is a bit of a ship for them. And you know, lots of people think leadership's about titles and leadership's about getting to.

Call the shots and having a lot of power. Um, but we, we really break down that leadership amongst to a lot of responsibility and, and good leadership is the ability to positively influence others. And, you know, it's, it's not something. For the lighthearted, it's something to be taken very seriously. So that foundational program is for when you wanna go from being an individual contributor to being a lead and a lead.

Um, doesn't have official direct reports, but they have to be in a position where they're influencing the activities on the floor. They are really the right hand of that supervisor that's on the floor or in the lab and they are making sure that their, their team is successful. And I think the hardest thing to do is to go from a peer to being someone who's got a little bit of what I would call unofficial authority.

'cause you're in this. No man's land. You're in this gray area. Um, and it's, it's easy to, to get lost. So, uh, we walk them through different scenarios. We walk them through different activities to get them to feel comfortable in a safe space about moving from that peer role to being in that kind of quasi leadership role.

So the next tier of it is the Emerging Leader series, and that's when you're ready to be a supervisor or manager. And it is also a year long program, but we meet once a month. It is also a hybrid program. It. It has books, it has online learning, it has assignments, and then we meet once a month. We do exercises that are designed to kind of bring to light and tie together everything that we've been learning about.

Um, there there's also a lunch and learn with our executive team where they get to ask questions of the executive team and really understand. What the needs of the business are and how they can support the needs of the business to drive success. Our third tier is the Senior Management Academy. When you're ready to move to a director or VP level, um, that is a four month program.

Pretty intense. We need every two weeks. Um, and it is hybrid. There's an online component. There is an in-class component, and there's meeting with the senior executive team with all three levels. There's also a mentorship component, so they have a mentor that they can go to and they can. Ask questions and they have assignments where they specifically have to bring assignments to their mentor and get feedback, and that helps them grow their network.

It helps them understand the importance of getting feedback, mentoring, and good coaching. So yeah, it's when. When I go into organizations and, and launch a leadership program, it's generally because they have had a track record of putting really strong, technically competent people into leadership roles, but they don't know how to lead.

They know how to execute the task. But when you are a manager or a supervisor or or a director or a vice president, your job is to inspire others to excellence. Your job shifts from being the doer to yes, the coach. And if you're, if you're proficient. At inspiring and leading and coaching, it looks easy. I, I kinda liken it to my, my thoughts about parenthood before I became a parent.

It, uh, had a lot of ideas about how I was gonna do that and right up until the point where they handed me this infect and I thought, and you're like, what do I 

Melody Keel: do with the person? 

Celeste Brantolino: And I think that's, that's a lot of like management, right? We've, we typically have all had managers before we become a manager, right?

So we all have very strong opinions about what we would do. We became a manager. But the tables turn, once you become that supervising work and you know, you. You, you are faced with conflict. You know, you are, you are faced with a team that isn't working cohesively, and you're just, I, I've seen some of my participants come back in and they're like, I, I need help.

And I 

Melody Keel: think for me, um. Having been on both sides of the line, right, and experiencing that, what do, what do I do now? Because I'm really good at running studies. And so now I've gotten the opportunity to manage a team and help them and mentor them, and I, I find myself in this director level role. Um, and you find out very quickly that leadership is service.

It's really helping your team and the people that you are responsible now for their output. It's not what I do personally. I'm responsible for someone else's work. Um, and so how do you motivate them? Encourage them, teach them to do the work at the level they need to, um, and that they want to work for you.

Because if your team doesn't feel like you have them, uh, as the priority and that you're in it for them, they will not work for you. And so there's so many lessons to be learned when you're becoming a leader and a manager and in that position. Yeah, 

Celeste Brantolino: and you know, there's so much truth to the adage. People don't leave companies.

They leave managers, right? So if you're not investing in a management development program, a leadership development program, you're gonna see turnover. Especially if you've got a lot of new managers. If you're not supporting them, they're gonna make mistakes. We all make mistakes as our, as we managers, but we'll, we'll make less mistakes and we'll recover more quickly if we support them with some leadership development.

Melody Keel: Absolutely, and what I'm seeing right now, because I think the market that we're in. You can't just leave your organization and and easily get another position right now. So we have folks that are staying in the role. They're not leaving. There isn't turnover, but they're not doing the work. They're quiet, quitting, they're passively aggressive with management that doesn't know how to manage them and is making their lives difficult.

I'm just seeing this vicious hamster wheel of poor leadership, um, at every level on the side side, on the sperma side, on the, at the vendor level. And it's just maddening to me because it's can be as simple as just showing people how to lead, right? 

Celeste Brantolino: And, you know, people, people won't follow you until they know you care about them.

Um, 

Melody Keel: and, and you are knowledgeable. You know how to do the work that you're asking them to do, and if you don't, you are in the red before you even get started. 

Celeste Brantolino: Absolutely. Absolutely. 

Melody Keel: Yeah. So I would, you know, we kind of identify, well, first of all, I just wanna say, I think your LEAP program is. I love it and I love that it builds.

And so there's a layer here, there's a layer here, and there's a layer here. And at each level it's more intense. You get more time. You have to commit more, do more, um, and show yourself approved. And I think sometimes that's the piece that, no, I think a lot of times that's the piece that's missing. We've mastered how to run a trial.

We've mastered these very important. Pieces that make a trial successful, but we don't have the soft skills or the management skills. And a lot of times the folks in the chairs that are the study team, they don't come from MBA programs, they're not business administration majors. And so we're learning on the fly how to be project manages and implement business principles and management and leadership.

And so I, I think it's so key that organizations get a clue. And implement and create programs like your LEAP program? Yeah. Yeah. Um,

Celeste Brantolino: I think once, once you get executive level buy-in for it, you know, it's easy. Um, I think a lot of organizations, um, don't always understand. If, if you make the investment, you'll get the return on that investment. What, what's that old science, uh, saying? Um, wise men plant trees knowing they may never sit in the shade.

You know, uh, it and the other saying, you know, oh, well if we, if we train them or if we give them this and they leave, we've lost that investment and. L and d people always respond with, if you don't and they stay, what are the consequences? Right. Absolutely. You know, and it's, it, it is really important because, um, I have seen high performing teams evaporate when.

A really ill-equipped person gets put in charge of them. They, they do the things that you talk about, the quiet quitting, the passive aggressive, the, the, you know, um, the sabotage. But they're, they're smart about it, right? Mm-hmm. Like they, they will, I have seen teams take down a manager. Because that manager just was so ill-equipped to lead that team.

And they were like, not happening. 

Melody Keel: Not here. Yeah. And it's sad to see, uh, to watch that because that manager, um, was most likely a peer of that team. Um, and so to see that kind of self implosion happen and then from a human perspective, it's. It's another human that's being mistreated that's on the other side of that, that has to go home and still be a family member or a friend or in the community.

And so that, that's just lends itself to the toxicity that I see that, uh, we all feel and see. And there's a way to, to alleviate that. And, and as simple as l and d. You know, it, it's, it lends itself to the culture. And I know I'm all about people, process, culture. That's, that's what I live and breathe. Um, from my perspective in clinical operations and training really does impact culture directly.

Celeste Brantolino: Yeah, a hundred percent. Uh, when, when you have, when you have a culture of learning, people go out of their way to make sure that. Their teammates are successful. Mm-hmm. They go out of their way to make sure that the business is successful when absent a culture of learning. You have a lot of individuals that are advocating for their own kind of self-interest versus the interest of the team, the interest of the organization at large.

Mm-hmm. Agree, and he suffers the patient, right? Who, who ultimately bears the brunt of the lack of leadership and organization and, and foundational culture. Setting the patient. They either don't get the medicine or the medicine isn't safe, pure, and effective. 

Melody Keel: I agree. I totally agree. And I think, um. I think it's just an unfortunate mishap that somehow we just of, um, decided that this is like a lower item on the totem pole, when really it has such deep reverberating implications when you don't intentional learning and training and development in your organization.

Celeste Brantolino: Right? 

Melody Keel: Yeah. 

Celeste Brantolino: But even if you get that support, you have to make sure that. A, a big mistake that I've seen with, with some l and d departments and some training departments is they, they get that initial support and they go off in a direction that, that makes them feel good. You know, they make these pretty courses.

They make these dynamic engaging things. They aren't making sure that they're driving the needs of the business forward. They aren't beating with the expert worker. They aren't going into the operation or the lab, and they aren't sitting down with them and figuring out what do you need to be successful.

Melody Keel: Right. They 

Celeste Brantolino: are, you know, I, I cringe when. I do a needs assessment and I see someone who's a trainer and I say, Hey, what are you working on? They're like, oh, I'm working on a training program. I'm like, oh, okay. So walk me through how you're putting this together. And they're like, yeah. So basically I'm taking what's in the SOP and I'm making a PowerPoint.

And I'm like, oh, okay. Uh, how much time have you, have you spent with people that are, are executing this? Procedure, and they're like, and they're just, they're blank staring back at me and I'm like, we, we don't, we don't create curriculum in a vacuum. We don't create master extra training plans on an island.

You know, we, we need to make sure that every training outcome is aligned to driving the success of. The operation of the labs forward. Otherwise, it's, it's wasting people's time. It's wasting resources and companies, that's why companies don't really wanna invest sometimes in l and d or in training because they, there's some bad players that just, they wanna make pretty PowerPoints.

Yeah. And there's, there's no alignment. To the overall needs of the organization. 

Melody Keel: They don't know, like you don't, hi, you don't go to, um, you don't go see a florist when you need surgery, and so you can't bring in a l and d group or department and then not bring in the experts who really know how to build that and implement it.

Celeste Brantolino: Right. 

Melody Keel: Yeah. 

Celeste Brantolino: Or the, the other kind of big mistake that I see is they will, they will take that best operator or that best lab person and they'll be like, okay, you're gonna train. And they flounder. 'cause they, 

Melody Keel: it doesn't qualify them, that doesn't qualify them to be a trainer. It qualifies them to be an expert that is sought out when the training is developed.

So that we understand how to do this properly and how, what is your workflow and how are you successful in this role? But it doesn't qualify them to teach others. Right? Yeah, sure. Yeah. And it, it makes me think about, um, some years ago, a lot of the CROs, the bigger ones w have the CRA training programs and, and you were known like.

If individuals sought those companies out because they knew they could get trained, they would be, uh, understand how to do their role and be successful as crass. And so, and I remember being a beneficiary of CRAs that went through those programs were assigned to my, my Studies as a sponsor. And it was just a market difference in the way the monitoring was executed from those CRAs that had gone through that program.

And it was like a LEAP program almost where it was very structured and you had levels you had to accomplish before you could be assigned to certain studies and teams. And it worked and then it just went away and. Now you have crass and, and, and, and They're good people. They're good humans. They just don't know how to execute the role properly.

And that impacts our trials, right? The data. The data is what we need, but the data is poor quality because this very critical role no longer has the training, support and development that's needed. Right? Right. Yeah. I don't know. I can't solve, we can't solve the world's problems one, one live show. But,

um, I hope that, um, the folks that take the time to listen to today really understand the importance and the criticality of formal training and development programs within their organizations. And if you don't know how to do that and you don't have the expertise internally. Go get it and bring it in so that your folks are supported and developed and feel like you feel they're worth the investment.

'cause the work output is so much greater when that's in place. 

Celeste Brantolino: Yes, 

Melody Keel: absolutely. So I'd love to have, I, I think the best way to end is for you to share, give us a gold nugget, some wisdom. Um. For those of us that are in leadership and have the ability to make the decision to bring in a formal L and d program or shore up the one we have and make the investment, what would be some wisdom or guidance you would give to that leader that was listening today?

Celeste Brantolino: Have the clear vision of what you wanna accomplish, the benefits that it will bring to the organization. And identify some key milestones to demonstrate that you are on track with your vision and your objectives, and make sure that it all ties in to the success of the organization. So it's, it's a aligned to the needs of the business.

Absolutely. 

Melody Keel: Awesome. Thank you, Celeste. I really appreciate you taking time outta your busy schedule to joining us today. 

Celeste Brantolino: Thank you, melody. This has been so much fun.

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