On this episode of Women @ RopesTalk, hosted by health care partner Christine Moundas, life sciences regulatory & compliance counsel Beth Weinman interviews Jennifer Zachary, executive vice president and general counsel of Merck. Jennifer describes her unique trajectory from science major in college to associate chief counsel at the FDA to law firm partner and finally to her role as the top lawyer at Merck. She breaks down the differences and similarities between private and public practice, noting that the desire to protect the public health is just as strong in both places, and shares important advice for early career attorneys: work hard, seek out interesting cases, surround yourself with lawyers you admire, and make sure you're having fun. Jennifer also describes the invaluable roles that mentorship, sponsorship and diversity efforts played in her transition in-house, and talks about the needle-moving diversity initiative she oversees at Merck.
Transcript:
Christine Moundas: Welcome and thank you for joining us on our latest installment of Women @ RopesTalk, a podcast series brought to you by the Women's Forum at Ropes & Gray. In this podcast, we spotlight extraordinary women who have had successful careers and interesting lives and are making a positive impact in their workplaces and in their communities. We feature women attorneys at Ropes & Gray in conversation with prominent women clients, industry leaders, and entrepreneurs—we talk about their careers and what's led to their successes, the challenges they've faced, and the hard-earned wisdom that they've acquired. I'm Christine Moundas, a health care partner at Ropes & Gray based in New York and co-head of the firm's digital health initiative. On this episode, I'm joined by my colleague, Beth Weinman, who's based in Washington, D.C. Beth, to get things started, could you please introduce yourself and provide a brief overview of your practice?
Beth Weinman: Sure. Hi, Christine. I'm Beth Weinman. I am counsel in Ropes & Gray's life sciences regulatory & compliance group out of Washington, D.C., and my practice is focused on compliance with, and investigations and enforcement-related to, FDA regulatory obligations, mostly, but not exclusively, in the drug and medical device arenas.
Christine Moundas: Who's the special guest that you'll be interviewing on this episode?
Beth Weinman: I will be interviewing Jennifer Zachary, aka "JZ," who is executive vice president and general counsel of Merck.
Christine Moundas: Excellent. And how did you meet and start working together?
Beth Weinman: We are both alumni of FDA's Office of the Chief Counsel (OCC), but we didn't actually work together because Jennifer left the Office the month that I arrived (she must have heard that I was coming). But JZ is a legend, and I got to know her through friends, OCC alumni events, and industry-focused conferences.
Christine Moundas: What would you say is the most notable thing about Jennifer's career?
Beth Weinman: That's easy: The fact that five years ago, she became general counsel of one of the world's largest pharmaceutical companies at such a phenomenally young age, and without working in-house before getting the job—that's pretty remarkable and a true testament to her talent.
Christine Moundas: That is amazing—thank you for sharing that. And with that, I'll turn it over to you and Jennifer.
Beth Weinman: Hi, Jennifer, or "JZ," as you're known in FDA circles. Thank you so much for joining us to chat today. You have had such an amazing career, and I'm really just thrilled for our listeners to be able to hear all about it. Why don't you just start by telling us a little bit about yourself?
Jennifer Zachary: Beth, thank you so much for having me, it's great to be here. I am currently the general counsel of Merck, and executive vice president, so in addition to supervising the legal department, I also oversee the environmental health and safety function for our company, global security, and aviation, as well. Before that, I was a partner at a large law firm in their food and drug practice. And before that, I was an attorney in the FDA on the civil enforcement side, and I also did a little bit of time at the DOJ on the civil side.
Beth Weinman: Great. When I think about the fact that you're covering aviation—and I know you as an FDA lawyer—I just think, "Wow, how crazy." But we'll talk about all of that—the trajectory of your career and how you learned to deal with the very broad scope that you deal with now. But, first things first: How did you come to law? Did you always know you'd be a lawyer?
Jennifer Zachary: I did not—I would say I was a bit of a late-bloomer with respect to the law. I was in college, and I was a science major, studying chemistry and biology, and doing research in biochemistry—that had me spending a lot of time in the lab, which was two floors underground, sifting through soil, taking measurements, and then going out in the field with my backpack. I was doing all of that by myself, or maybe with a handful of other people, and I realized that, even though I love science, it was a pretty isolating experience, the research path that I was on. And so, in my fifth year of college—yes, it was my fifth year—I pivoted, and decided that I would go to law school. Part of why I was excited about law school was my sister was in law school at the time, at Yale, and I had gone out to see her do moot court, and I thought it was amazing. Then, I learned that there were all these ways you could use science in the law, and so, I thought, "Maybe I could make those two match up, and have a career where you could do science, but also spend a lot of time with people, and out in the world."
Beth Weinman: I was going to ask you how you got to your first job, post-clerkship at FDA, but your science background must have been a part of that.
Jennifer Zachary: It was definitely a part of it. I thought in law school that I would be an environmental lawyer because I'd studied ecology, which made sense. Then, when I was allowed to take my very first elective, which I think was over the winter of our first year, I took environmental law, and realized that it was mostly, at least what I was studying, about apportioning blame for pollution or other horrific things that had already happened—like, for whatever animal is extinct: "Whose fault is it?" And that really did not speak to me. But then, in my second year, I took a food and drug law course from Peter Hutt, a luminary of our field—he was the former chief counsel to FDA in the late '70s.
Beth Weinman: He wrote the textbook.
Jennifer Zachary: He literally wrote the textbook, yes. I took his course, loved it, and then decided from there that I desperately wanted to be an FDA lawyer, although the path to get there was not so clear—straight out of clerkships, FDA used to not hire people.
Beth Weinman: I didn't realize that. So, how did you get there?
Jennifer Zachary: I had Peter Hutt as a mentor, and then, actually, I was dating a guy my third year of law school who was already working in a law firm in Boston. The partner he worked for was related to someone in the counsel's office at FDA, and so, I made that connection and cultivated that relationship. Then, I got really lucky because there was a huge budget crunch, and FDA couldn't afford to hire what one of my colleagues referred to as "real lawyers," so, I and two other folks were hired straight out of law school or clerkships, and I got extremely fortunate, I think.
Beth Weinman: That's great. Let's talk about your time at FDA. You were in the chief counsel's office the entire time you were there?
Jennifer Zachary: Correct—the entire time, which was five and a half years, I think.
Beth Weinman: What's the nature of what you did there? What kind of work?
Jennifer Zachary: When you first come in, they wanted you to cut your teeth with a broad range of the simplest cases, so that was often foods cases and enforcement. One of my very first cases, I remember, was a whole shipment of canned crabmeat that had been in the trailer of a semi-truck when the refrigerator part had gone out, and they were still trying to sell it. Somehow, FDA got wind of this fact, and so, we needed to seize the truck container with all the spoiled crabmeat. That's a tough case to lose because those usually proceed without any party on the other side—you're literally litigating against the truck container. I managed to win a few of those, but that's where you start your career at FDA.
Beth Weinman: Fantastic. Then, you moved on to doing stuff besides in rem seizures of crabmeat?
Jennifer Zachary: Exactly. Yes, I moved along, started doing more in the medical device and the drug space—both offensive cases, where we were suing to stop people who were violating the law (producing products that were unsafe), but then, also defending the Agency when their approval determinations and other regulatory decisions were challenged. So, I got a nice range of both enforcement and defensive matters.
Beth Weinman: What was the best moment, if you can think about it, of your tenure?
Jennifer Zachary: My best moment at FDA: It's hard to say, there were so many great moments. I think one of the highlights for sure was I had a big case that was a TRO (temporary restraining order) out in Wyoming. The company was producing unapproved new drugs that were actually opioids, so a pretty significant public health risk posed by that, and so, FDA had gone to shut them down, and they didn't want to be shut down. So, it was a TRO hearing in a pretty unfriendly jurisdiction: Cody, Wyoming. The Department of Justice and I flew out for it on very short order, but it was a great hearing—we ended up prevailing, which was really satisfying. It was high stakes and a big FDA initiative—it had a lot of attention from the commissioner and the center director at the Center for Drug Evaluation and Research within FDA, and so, there were a lot eyes on it and I was nervous. I remember my boss, Rick Blumberg, who's a luminary at FDA and ran enforcement for many years, said to me, "Have fun and win. If you don't win, don't come home." He kind of laughed, and I knew he was mostly kidding, but I think that that advice, like a lot of the advice that he had, was good: If you're not having fun with whatever you're doing, whether it's the law or something else, you're not going to do it very well. Focusing on making sure you're having fun, knowing that the cause that you're pursuing is just, and then fighting really hard to try to win, I thought, "That's a great encapsulation of what I think is the best of being a lawyer."
Beth Weinman: That's great. Clearly Rick felt that way because he spent 40 years doing just that. I was going to ask you what the most important lesson you learned at FDA was, but maybe it was learning how to have fun as a lawyer.
Jennifer Zachary: I think that's right. I think another important lesson I learned there was definitely that you have to work hard. You have very limited resources when you're a government attorney—you're usually fighting against people who are much bigger, with many more lawyers and many more dollars behind them—and so, you have to work incredibly hard. You have to have grit, determination, and know that not everything is going to break your way, but that you have to just keep fighting and believe in the cause. I think that was also really good training to be a lawyer.
Beth Weinman: You had this amazing job, you had fun, you did this important work, and then you left—you went to a law firm. So, tell us why. What was the transition like?
Jennifer Zachary: The transition was both difficult and surprisingly easy. I left FDA, if I'm completely honest, because my law school loans were not going to pay themselves. I had been in the government basically between my clerkship and FDA, for almost seven years, and I needed to pay back those law school loans. I had litigated a number of cases against a number of law firms that were prominent in the space. I could see myself, to some extent, on the other side, but I thought it would be very temporary. I thought it would be two years—I had this whole two-year plan, and then I would come right back to FDA with the experience that I had gained in private practice.
I was so certain it would be two years that I literally made a paperchain that had 24 links in it—I would cut off a link each month, staple it to a piece of paper, and write a little note to my boss, Rick, and his deputy, Anna Marie, and just tell them in non-privileged terms what I was up to, what I was learning, and just checking-in. Then, I quit sending those notes about a year in, and he said, "We knew then that we had lost you." It turns out I loved private practice. I think that the desire to protect the public health is just as strong in private practice attorneys as it is in the Agency. It's just as a private practice attorney, you are the front lines—you are the people in the room with the company when they're making really important decisions, and you can help to ensure that the decision they make is the right decision and keeps people safe. Once I understood my role, and the really big impact that you could make in private practice, then I was completely content and felt like it aligned with my values. Also, being a private practice attorney is so great because everyone brings you their hardest, most interesting problems. To this day, I'm still super-jealous of some of the projects that we send out—of course, I get the report, but it's not the same as being the person who does the deep thinking, writing, and the research. It was definitely a transition that was challenging, but ultimately, very rewarding.
Beth Weinman: The thing I loved hearing, when I was at OCC also, was how important it is to have well-trained FDA lawyers in the Bar on the outside. I definitely feel like people were understanding because, in order to move the mission forward, you need to have people who know what they're doing on both sides of the aisle. So, you found the joy in private practice, but you also came in pretty senior and experienced. What advice would you give to a young lawyer in private practice about trying to find the joy?
Jennifer Zachary: I think that I would give similar advice to what I enjoyed as a young lawyer at the FDA, which is: Know you're going to work really hard. Make sure that you're taking on projects that are interesting. Now, not every project will be interesting, but do your best to try to find the ones that are interesting and really pour yourself into those. Focus on working on things where you know you're going to learn something, where you think you can actually contribute—be someone who other people within the firm are going to look to to know something about X. Then, I think maybe the most important thing, at least for me in private practice, was making sure that I surrounded myself with attorneys who I admired; people who I really respected; thought had done interesting things with their career; took the time to mentor and teach me; cared about the people around them; and focused on having good clients (clients who wanted to do the right thing). All of that, I think, you find in the government, but you can just as easily, as a younger lawyer, find that within a law firm, but it takes being pretty thoughtful.
Beth Weinman: How did you deal with the situation, if it arose ever, where your client didn't want to "do the right thing" when you knew what the right thing was?
Jennifer Zachary: Yes, it's really challenging. I think, at the end of the day, everyone wants to do the right thing, but there are impediments, and so, trying to help them to understand that the impediments that were presented by not doing the right thing were so much worse. Usually, that really required helping that internal person to educate their colleagues at the business, who probably don't have the same understanding of the consequences.
In food and drug law we have something called the Park Doctrine, which is strict liability for even misdemeanors where people had no intent, and maybe not even knowledge, and so, making sure that people understand the really serious consequences of making a choice in this space that isn't the right one, I think, was the biggest thing. I never did have to resign from a client, but I will say there were definitely companies that I preferred working for, and who I would put more of my efforts into cultivating relationships and working for, versus companies where I felt like the lawyers had a little less say-so over their clients, or a little less direct control, because I just didn't enjoy that as much—it didn't align as much with my values.
Beth Weinman: That makes sense. It's for sure hard to find the joy when you feel like your own values are being challenged. So, you did enjoy your work in private practice, but you're not there anymore because you had this amazing opportunity arise. Tell us, how did the opportunity at Merck arise for you?
Jennifer Zachary: I did leave. I was not looking to leave—I was surprised when the opportunity came along. Merck was certainly on a very short list of companies that I would have had an interest in going in-house to work for.
About a year and a half before the opening at Merck came about, I had done a big project for them in the pharmaceutical regulatory space, and it was one that had a lot of attention from their executive team (CEO, CFO, and the head of research) as well as requiring a fair amount of time with the board (head of the audit committee and lead director), and so, I got to spend some time with those folks. Hearkening back to what we talked about earlier around the idea of surrounding yourself with lawyers who are really strong: Merck hadn't hired me—they'd hired a partner at my firm who is an incredible lawyer, Richard Kingham at Covington, and he insisted that they take me as part of the package. He really believed in mentoring, and so, on a very big project he put me out front and center—that's how I ended up with all of this exposure.
When Merck did end up with an opening—their general counsel was leaving to take another GC job sooner than they expected—the then-CEO, Ken Frazier, who's a huge advocate for diversity, very much wanted to add some female representation to his executive team, so they were looking for a female lawyer. He was the former, by the way, general counsel, and a very well-regarded lawyer in his own right. He knew he had a couple years to bring me along and get me ready before he was going to transition out of his role. I think to get a job like general counsel of a Fortune 100 Company about 10 different things that are highly improbable all have to align in that moment for that to happen. I think that's exactly what happened, but I was very fortunate, and I have enjoyed it. It's now been five years, which I can't believe.
Beth Weinman: That's amazing. I remember when the trade press hit and I thought, "She's so young to lead!" So many people that we know, and you know, too, who are in in-house roles, they grew up in in-house roles. Oftentimes, they go to private practice and they hate it, they don't find the joy, and then they look for those in-house roles that train them from one smaller role to bigger to bigger roles—but that's not you. I guess my question is—you're this partner in this fabulous FDA practice at a law firm who's happy, going about your business, and then, you are presented with an opportunity at this groundbreaking, massive, global, pharma company—how did you feel ready, and what did you do to prepare?
Jennifer Zachary: I didn't feel ready at all. I will say, in retrospect, that I don't think law firm lawyers give themselves enough credit for the amount that they know. Even someone in a pretty specialized space, like my FDA regulatory space, I worked on a lot of deals, I worked on a lot of intellectual property matters, a ton of litigation, a lot of investigations, obviously regulatory, and the skills in regulatory translate to a lot of different regulatory areas. So, I feel like, in retrospect, I had more background than I realized. That said, there was a lot I didn't know.
It cracks me up because later, my boss, Ken Frazier, said to me, "At the beginning, you were just so confident—I was a little worried. Then, later, you seemed to understand that there was a lot you had to learn." But I was blessed. Merck had and has some really stellar in-house lawyers who are excellent in their space, and they were really good at helping to educate and teach me. I think one of the most important things to do when you move into a role, where you know in your heart that you're not quite ready, is to be humble, and to admit to people that you don't know things, that you're trying to figure it out on the fly, because people will help you. A great example of that is that the general counsel of Merck—two before me, a lawyer named Bruce Kulik, who also has a long government background, and I knew him, he was a mentor—once he knew that I was going to take the job, he gave me a GC boot camp. He literally sat down with me for a whole day, had an agenda, and walked through what I needed to know, both to be a GC, but what I needed to know about Merck, since he had been the GC there. It was incredibly thoughtful and really helpful.
Beth Weinman: So, it's been five years: Do you feel like you've found your groove?
Jennifer Zachary: I do think I've found my groove. It's definitely taken a while, and one of the things I love about the job is there's always something new to learn, there's always a new matter to take on. I do feel like now I have a great team in place, people who I'm really comfortable operating with. Our executive team has had a lot of transition in those five years. We now have a new CEO, Rob Davis, and I am the second-most-senior member of our 10-person executive team, so we've had a lot of transition. I feel like I've found my space and found the areas where I think I contribute the most and the people with whom I have found my kinship, so I think I have found my groove.
Beth Weinman: That's great. What types of issues these days keep you up at night? What do you worry about?
Jennifer Zachary: I have to say one of the keys of a GC job is really trying not to let things keep you up at night. I think that to have longevity in this role, you have to have a certain amount of Zen, which requires working with a great team, and all of those things. In terms of the issues that get my attention, it's anything that causes disruption. Merck is a 130-year-old company, and we are very good at what we do, which is finding products that save and improve lives, but in order to do that, to be the well-oiled machine that we are, we need a certain amount of predictability. Bumps along the way are not helpful, so the things that I worry most about are disruption that's unanticipated.
We've had a lot of that in the last three to four years—the most obvious example, of course, being COVID. But then, geopolitical unrest: There's Russia/Ukraine and a number of other geopolitical tensions. Political transitions in the United States have also been challenging. There's relatively new legislation, still less than a year old: The Inflation Reduction Act that has drug-pricing provisions that have a significant impact on the pharmaceutical industry and are changing how we think about R&D and the development of products at Merck. And so, the issues that have my focus and have the majority of my attention these days are the ones that cause the most disruption.
Beth Weinman: I want to know what it was like to be two years at Merck as a new GC, and then a once-in-a-century global pandemic hits.
Jennifer Zachary: It was crazy. I think it was crazy for everyone—not having any kind of a playbook and not understanding what that looked like. In some ways, it was very fortunate because we have on staff some of the world's preeminent physicians and researchers in the pandemic space. The former head of the CDC, Julie Gerberding, who guided us through previous much smaller-scale pandemics, was one of my colleagues on the executive team. And so, we had a lot of expertise around us, but we had to try to figure out how to run a business in that time and think about how we could best contribute. We had two different vaccine candidates—actually more than that—that we made public that failed pretty spectacularly, along with many of our peer companies. We ultimately ended up agreeing to be the manufacturing muscle for J&J on their COVID vaccine, which ultimately, it, too, proved not to be the most successful of the vaccines. Trying to find a way to contribute, we came up with some therapeutics that have, I think, been helpful. But it was a really challenging time: Trying to do right by our people, do right by our customers, and all of that, kept me very busy. I feel like I had a minor, if you will, in HR in that time period, as well.
Beth Weinman: Fascinating. There are so many issues separate and apart from the role of being a pharmaceutical company in a pandemic space, all the HR, and to have to deal with that, it must have been intense. I'm glad, and I'm sure you are, too, to see that people are at least focusing on, "Let's get prepared for the next time, so we're not caught flat-footed." You talked a little bit about how you benefited from Merck's interest in diversity. Are there efforts or successes besides you regarding diversity, equity, and inclusion that you are particularly proud of and can tell us about?
Jennifer Zachary: Yes, absolutely. I think as a company we're doing a lot of great things. I think an example from my space, that's near and dear to my heart, is we have what we call the Merck legal network diversity program. Our Merck legal network is a group of about 10 firms who we do the bulk of our work with (the majority of our billable hours come through those firms). As a result of our patronage, we ask certain additional things of those firms, and one of them is some pretty robust reporting and engagement with us. We launched this program now three years ago. We have a diversity committee internally in our legal department, where we work with each firm in the network to establish bespoke diversity goals for that firm. Let's say they're doing a great job of making sure that they provide us with diverse associates, specifically, African American male associates. Then, our goal might be something like Asian American female associates—very focused goals but working with them back and forth to try to figure out what's really going to move the needle. Some of them are much more like, "On your comp committee, what's the representation look like? What commitment can you give us about transforming those institutions that have historically not been diverse?"
So, we set these goals, and then the firms work towards them. At the end of the year, we apportion a million-dollar pot of money that we've set aside, and we award them based on how they did with their goals. It's been an amazing program because many of the firms have stepped-up. And with the $250,000 or the $500,000 that they were given for winning that particular year, they've plunged it back into their own internal diversity efforts, and it's been great—I really love how that works. We're not the only company that does this, but I think we've really concentrated on providing a carrot and a lot less of the stick. I think too much of the diversity stuff is negative, and I think that we have our own challenges internally with respect to representation, and half the time we're stealing the best talent from our firms. So, I think that the idea of a partnership, and working with them, was really something that's a little bit novel to Merck.
Beth Weinman: Are you seeing change? If your firms are meeting their goals, then are you seeing it from a macro level?
Jennifer Zachary: Huge. It's both specific to our matters and across the firms, and that's partly the times. Last year, we had a huge trial, an intellectual property trial, and one of the goals at that firm had been to actively engage diverse associates. And so, we had a fourth-year and a sixth-year in a trial that was worth literally billions to our company, doing directs and crosses of witnesses—associates getting stand-up time as third- and fourth-years in a case that meant the world to us. And they won—that firm won that year for their commitment. I really think in concrete ways, both statistically speaking, but then in anecdotal ways, that we are moving the needle with the program.
Beth Weinman: That's terrific. It seems like you've really just—who knows what the future holds for you, but—at the top of your game in this role, and with what you see, it's always so interesting to hear about that. But tell me: If you weren't a lawyer, what would you be? Anything?
Jennifer Zachary: I hope it has come through in our conversation, Beth, I love being a lawyer, but if I could do something else, maybe hearkening back to my ecology days in college, I love to be outside. When I take vacations—I do take my vacations, and I encourage everyone to take their vacations because it's important for our mental health—they always involve significant amounts of time outside and doing athletic endeavors. So, I could see myself as an outdoor instructor, guide, or something cool like that. I always joke that the forest service has installed cameras in most of the fire towers in the U.S., so they're no longer available to be paid to be a summer firewatcher.
Beth Weinman: So, that's what you wanted to do?
Jennifer Zachary: There's a couple left, and in order to qualify—it's very competitive—you have to have had soil science, and I had two years of soil science. I love the idea of sitting in a fire tower with a huge stack of books, totally out of reach except for a satellite phone, and occasionally looking out and being like, "No fire." I don't know if I could do that more than a summer.
Beth Weinman: I would love to be at the Park Service when your resume comes in for that job.
Jennifer Zachary: I bet you're like, "This person's clearly burned-out."
Beth Weinman: It has been so much fun catching up with you and learning about your career, but I think our time is sadly running short. Can you leave us with something about yourself that we wouldn't learn from your LinkedIn or Merck bio, aside from your dream to spend a summer in a fire tower?
Jennifer Zachary: I am from Oregon, I'm a very proud Pacific Northwesterner. I still have a lot of family back there, including my sister and brother-in-law. My sister is a recovering lawyer—they have a farm. I love to spend time in the Pacific Northwest drinking the amazing microbrews, coffee, and Pinot Noir, and just being out in Nature. I suppose that probably doesn't come across in my very corporate LinkedIn.
Beth Weinman: Terrific. Thank you so much and I look forward to talking to you again another time.
Jennifer Zachary: Thank you, Beth, this has been great.
Christine Moundas: Beth and Jennifer, thank you both so much for that insightful conversation. And as always, thanks to our listeners.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
