Amy Lavelle, Ph.D., shares career experiences and advice in a recent interview.
Earlier this year, Amy Lavelle, manager at PPD, answered questions from the AAPS Career Development Committee. Lavelle began her career in contract research and biotechnology as a scientist at Commonwealth Biotechnologies, Inc. She received her doctorate in human and molecular genetics at Virginia Commonwealth University. Lavelle returned to the pharmaceutical industry in 2009 as a principal investigator in the Immunochemistry Research and Development department at PPD. She manages a team of research scientists supporting ligand-binding assay method transfer, development, and validation. She has served as R&D lead in a sponsor dedicated program focusing on tech transfers and method development of novel biologics, particularly anti-drug antibodies, and commercial and novel biomarker good laboratory practice (GLP)-like validations and non-GLP qualifications. Lavelle also leads a departmental anti-drug conjugate focus group and is part of a cross-functional Cell and Gene Therapy Task Force, focusing on training strategy. She is a co-lead and learning opportunities manager for the AAPS Women in Pharmaceutical Sciences (WIPS) Community and a member of the AAPS Career Development Committee.
How many years have you worked in this industry?
I’ve been in contract research organizations (CROs) for a combined 15 years, first working for a small biotech/CRO then at a large CRO after grad school.
Briefly describe your career path up to this point. Was there anything unusual or unprecedented about your career progression that led you to where you are today?
When I started as a scientist at the small biotech, I was given the impression that I would need a Ph.D. to move forward in my career path. So, I went and got it, knowing I wouldn’t stay in academia. I lined up a postdoc in an academic lab, but after only three weeks, I realized it was not what I wanted. It was not aiding me in the career path I wanted in industry, and I had a 7-week old baby and needed health insurance with a “real” schedule! I guess I can thank my daughter for my career path! I applied to my current company as an associate research scientist and have been there ever since. I wouldn’t say there is anything particularly unusual about my career path other than I’ve stayed with the same company for a significant amount of time (more than 10 years at this point). I think there are differing opinions as to whether that would hurt or help one’s career.
What are the skills that are most important for the position you hold?
Scientific and regulatory understanding is at the root of what I do, but in my current position I think the most important skill is being a successful leader. I am only as good as my team and can only do my job well if they are doing their job well. Building and supporting my team is very important to me. Good communication skills also factor into this, as well as in my interactions with my sponsors. I think these two skills are often hard to learn and require a certain amount of natural ability, or a lot of hard work.
Adaptation is also important. Working at a CRO, I am exposed to a multitude of different approaches to drug development. While we all follow regulatory guidance, there is a lot left to interpret and it seems every sponsor has their own interpretation. Being able to apply knowledge learned across years of experience to ensure the best approach for each sponsor has been an important skill. And, of course, the ability to adapt to a changing environment can be applied not just specifically to my work, but to my position, my department, and my team.
What major threats/opportunities do you foresee for this industry and your company in particular? How do you plan to handle them?
Individualized medicine and the new modalities that are making their way to clinical trials are the biggest conversations right now for my area of pharmaceutical science. Cell and gene therapy are at the forefront of research to make individualized medicine a reality. But these therapeutic delivery systems pose the need for a new strategy for analyzing and evaluating clinical data. How do we develop and validate methods appropriate for adeno-associated viruses, lipid nanoparticles, microRNAs, small interfering RNAs, particularly when you only have one patient or when you have tissues, like in the brain, that can’t be taken from a patient in treatment? It’s very different from what we are used to, and we’re learning the best approaches along with regulatory agencies. It’s exciting but also intimidating, venturing into mostly uncharted territory. We are working closely with sponsors to understand their approach and come up with our own “best practices” for those areas where no guidance or even experience is available.
Also the surge of AI and new technologies that are on their way. AI will always need people to manage the work, but it does take away from certain roles people currently hold. But it’s also exciting in the variety of applications and has potential for making jobs easier. I hope to be at the forefront, piloting new initiatives and identifying strategies to incorporate AI into our day-to-day work.
What has been your greatest career disappointment? What did you learn from it?
My greatest career disappointment is not focusing earlier on my career growth in different environments. Since getting my Ph.D., I have worked in one industry setting. While I think it is engaging and gives me broad exposure to many industry and regulatory practices, I was unaware of opportunities like postdoctoral positions at pharmaceutical companies that I could have done following grad school. I also think working in other environments (for example, pharma versus CRO versus small biotech) would have given me a broader perspective not just on the work being done but on the people doing the work. For now, I am focusing on networking, attending conferences, and connecting with a variety of people in the industry to give me that broader perspective while in my current role.
What is your leadership philosophy?
I’ve had personal experiences that have shaped my leadership style. Working for various managers, I’ve decided what I like and don’t like and what works for me and what doesn’t, and I’ve tried to apply that to how I lead now. I think micro-managing, not giving credit where credit is due, and not providing opportunities to my team only brings me down. I love coming to work every day, and I want my team to feel the same way. I try to establish relationships based on respect, trust, and support with my reports because that is how I want to be managed. I also think it’s important to understand and respect the role you are currently in. While I need to have the scientific knowledge, I am no longer on the bench, so I rely on my analysts to be my experts in that respect. They rely on me to have the theoretical knowledge, experience, and communication skills to interact directly with our sponsors.
What is the best advice you have ever received?
Speak up and don’t doubt yourself! I’ve always been hesitant to raise my hand, but I often find myself thinking, “That’s what I was going to say!” So why wouldn’t I just say it first? I’ve come across many people who just speak for the sake of speaking, and I think I went overboard trying to avoid that to where I would say nothing at all. I’m still realizing that I know a lot more than I tell myself!
Where does the nexus rest when considering scientific knowledge and the necessary leadership/management skills needed to be successful?
Being a good scientist and being a good manager can be two very different things. It is important to develop leadership skills while at the same time staying up-to-date with current industry advancements. But also, be aware of where your skillset lies—some people are excellent scientists while maybe not the best people leaders. We don’t have to be great at everything, and it is more beneficial to recognize where improvement is needed. Focused development and training on either side is necessary to be successful in both. Being humble, asking questions and knowing you can always learn more will only help you become a better scientific leader.
Do you have any special words of encouragement or warning as a result of your experience?
Finding the right niche for yourself can get you ahead and exposed to new opportunities, but you need the right support team behind you. First, identify the skills that really help you stand out. Then, find a manager who truly supports you and can help you develop those skills. You can then apply those skills to new opportunities or use them to improve existing issues and really stand out in your role.