For this edition of the Career Perspectives series, we had the pleasure of speaking with Ajay Sathe, retired Country Manager, India, and now Independent Consultant, who has worked with Cytel for 28 years! Ajay shares memorable career milestones and discusses the evolving role of programmers and the skills necessary for the future of drug development.

Can you give us a little background on your career so far? What prompted you to join Cytel when it was a fledgling entity in India?

I got hooked on computing and quantitative methods early while studying engineering. When India’s top B-School accepted me, I didn’t want to pass up the opportunity to study for an MBA. But even during the program, I stayed focused on things like optimization and simulation rather than finance and marketing. My first job involved scheduling helicopter sorties on offshore oil rigs to minimize operational cost.

I credit my joining Cytel to our co-founder Nitin Patel, who was my professor. He knew I could handle complex quantitative stuff and reached out to me when both founders were toying with the idea of setting up operations in India. It was a fantastic intrapreneurial opportunity, which I nervously accepted. But it succeeded stupendously beyond my imagination! This is my 28th year at Cytel!

Looking back, what were some of the biggest challenges you faced while helping build Cytel India from the ground up, and how did you overcome them?

There are quite a few stereotypes in the western world about India’s work culture. While technical competence is well acknowledged, the work ethics and efficiency are constantly in doubt. My pioneering team resolved to resoundingly bust these myths. Thankfully we succeeded, both with Cytel’s leadership and with our earliest Functional Service Provision (FSP) services clients who were top pharma clients.

Another sustained challenge was to build a stable team ― to hold down employee attrition rates to single digit percentages. I feel proud to see the vast proportion of Cytelians tend to have long tenures.

And then there was the challenge of offering value from India, beyond mere cost arbitrage. I delightfully chuckle to say that a big part of the East team was successfully built in the East. And they continue to deliver value well beyond cost arbitrage!

You served as country manager but had both technical and managerial elements in your role. What made you choose this combination?

The technical elements were my first love. The managerial elements were the need of the hour, rather than my conscious choice. Looking back, my strength has been diligently doing whatever is needed. I put my head down and got to work, and it worked! I had an irrational dislike for commercial roles like business development and customer engagement but when pushed into it, I found these exciting beyond belief. While sales was never my formal role, several thrilling wins had my substantial contribution. My sound technical understanding of the client’s needs was much appreciated. To quote a top pharma VP after I had made a successful sales pitch: “You know why you impress us? Because you don’t talk like a sales guy.” I was quick to point out that folks in the Cytel Sales team generally have strong technical background ― one of our unique selling propositions.

I can emphatically say that everyone aspiring to grow into leadership roles should welcome the techno-managerial combination.

You have been with Cytel for almost 28 years now. What are some of your most memorable milestones or proudest achievements?

I can readily name a few that I witnessed from close quarters.

When we first built the Windows version of East, with a Graphical User Interface (GUI) rather than a character interface, I crafted a visual prototype of the user interface using MS Excel (though the engines were always steeped in sophisticated C++ code). Why Excel? Because it was extremely useful for rapid prototyping. The users liked the prototype so much that it ended up becoming the product! It took hard work to wean users away from Excel eventually. Then the day came when we proudly proclaimed on our T-shirts that 47 of the top 50 biopharma companies were East users! And so were most divisions of USFDA!

Another milestone was Cytel’s foray into outsourced services, which began with one of the top pharma companies entrusting us with a relatively simple task. Evidently, we did a good job as they became an equity investor in Cytel! That stood as a testament to our credibility and their trust. Fast forward a couple of decades, and prominent private equity firms took Cytel to greater heights.

Lastly, I always strived to give young Cytelians global exposure by encouraging and mentoring them to showcase their work on big stages. We send several people to PHUSE annual conferences in Europe regularly. The thrilling moments for me were when three years in a row, rookie colleagues from India won best-in-the-stream prizes for their presentations! We were being watched by global leaders from our client and prospect companies. I have no doubt that this approach helped us in two big ways: winning contracts in global competition and retaining and nurturing talent that could clearly see the growth path.

What do you enjoy most about working at Cytel, and what’s your message for our current or future workforce?

Cytel gives you unmatched opportunity to look around and get involved in a wide range of activities and functions. This is very unlike most CROs who operate in rigid functional silos. At Cytel, you get to see the big picture, and you are encouraged to grow your skillset wider too, not just deeper. This is a key catalyst to long-term career growth.

My message to the future workforce is to preserve and enhance your curiosity. It is not only appreciated at Cytel but also channeled with top-class mentoring and guidance. One has the opportunity to keep learning new things all the time. It is important to grab those opportunities and march forward. There are lots of success stories to see.

On the whiteboard in one of our founders’ offices, a biblical phrase is written in permanent marker that sums this up: “With all thy getting, get understanding!”

What advice would you give to someone stepping into a leadership role in a growing organization today?

Leadership roles increasingly demand leading by example. You have to be able to do what you expect your team to do. This requires an astute balancing of three elements: encouragement, posing small but achievable challenges, and empowerment to catalyze success. Small successes are incredible booster rockets for performance.

Simultaneously, deep involvement in HR matters is crucially important, regardless of your function or specialization. Handling people well is a critical success factor, and I have seen all successful leaders — without exception — develop a great ability at managing people and their needs and aspirations. You get to learn this on the job all the time. You just need the desire to learn.

What legacy do you hope to leave behind in the clinical research community?

I have often sought feedback from my colleagues and sought to do course correction. Hopefully, I will leave behind a few things to emulate:

• Passion. Doing every little task thoroughly. It shows up in the quality and extent of one’s accomplishment.
• Curiosity and hunger. Soaking up little new things to learn, all the time.
• Attention to detail. My colleagues used to mock my obsession with correct grammar and expression, as also with accurate facts and figures. But mockery slowly morphed to admiration and emulation.
• Leading from the front. Doing myself first, what I wanted others to do. I discovered that this was the most potent power to persuade.
• Competition with oneself, rather than with peers. Striving to do better today than yesterday, and better tomorrow than today.

Looking ahead, what skills and expertise do you believe will be crucial for the future of drug development?

I feel the demand for skills is expanding sideways, from specialization to versatility . From depth to breadth. Regardless of your function, I feel the following skills will become increasingly crucial.

• Technology skills: AI, analytics, and automation
• Managing customer experience: Understanding true needs of the customer and delivering them.
• Agility and flexibility: Just like agile methods in software development, the industry will demand agile methods in everything. Project plans will become fluid, and people will be expected to adjust to evolving needs.
• Cross-disciplinary knowledge: Increasingly, you will be required to know a bit about everything. You can’t afford to say, “That’s not my area.”

The programmer will increasingly need to understand enough of data management, statistics & analytics, and computing (specifically prompt engineering). I see many different roles evolving toward a common versatile role — that of a Data Scientist. I am a firm believer that being a “jack of all trades” is more important than being a “master of one”. This will get increasingly reinforced.

Your enthusiasm and passion for Cytel and your work are truly infectious. What fuels that passion, even after so many years?

The most precious thing about Cytel I experienced, is that the company takes care of your growth and advancement spontaneously. Never in my 28 years did I have to ever ask for a raise or a promotion. My role evolved, and as I delivered on the growing or morphing expectations, I got rewarded, sometimes beyond my expectations.

I have been more dutiful than hardworking. Hard work was an incidental necessity of delivering on duty. It never felt like a burden, because the work was always exciting, and the results were always gratifying, and sometimes spectacular. The company truly took care of me. Such has been the leadership of the company.

My biggest motivation has been watching my next 2 or 3 levels in the organization, growing steadily in capability, and taking bits of my tasks and doing them better than I did! I see this as a multiplier effect. Instead of improving my individual performance by some percentage points, my team was delivering in increasing multiples. The aggregate competency in the company grow geometrically! That gave a stupendous sense of accomplishment.

You played a key role in bringing PHUSE to the Asia Pacific region and served as PHUSE’s APAC Regional Director. What inspired you to take on that initiative, and what impact do you think it had?

My first exposure to PHUSE was in Berlin, when I was gently pushed into making a presentation. I was thrilled to see the high level of energy, capability, and ingenuity in that audience. Their CSS (Computational Sciences Symposium) in USA, in partnership with the USFDA, is a fabulous collaboration of bright minds pushing the frontiers of drug development.

So a few years later in Brighton, UK, when the PHUSE board asked for a volunteer to carry the movement to Asia, my hand shot up.

I started with a Single Day Event in Hyderabad, India, and the movement rapidly spread to China and Japan and beyond. PHUSE inducted me onto their board of directors, and here we are today, with the biggest chunk of PHUSE membership in APAC! To be sure, a big credit for that goes to the Asia Director who came after me ― Sarvesh Singh.

My impact, I think, has been to help the Asian talent pool tap into global opportunity, and utilize their potential by rising to the occasion.

What did receiving the John Hirst Award for lifetime contribution mean to you personally and professionally?

John Hirst was a widely admired industry stalwart. I am honored to be among a handful of people recognized over the 2+ decades of PHUSE existence. The acknowledgement was very gratifying, so it motivates me to keep up the effort, despite my retirement from managerial roles, to help talent and demand find each other! Professionally, it is a recognition that makes me look back with contentment about having made a positive difference to our professional community. Personally, it’s a lovely feather in the cap along with some nice accolades I have earned.

Finally, what are your main interests outside of work?

Instrumental music! I am blessed with the ability of picking up new musical instruments fairly easily. Over the years, alongside long hours of work, I have de-stressed by picking up over a dozen musical instruments ― all self-taught. I have a YouTube channel that has over 250 popular songs based on Indian films and classical music, played on the flute, Hawaiian guitar, harmonica, aerophone, geoshred (an app on the iPad), piano, melodica, the santoor, and the tabla. And I keep exploring more instruments!

When I retired, I never had a problem finding ways to spend my time. Add to that an active interest in reading and sports, and I have my plate full! When I was working, I truly enjoyed the work; and now I continue to enjoy these other engagements. I have been fortunate in many dimensions in my life!

Thank you, Ajay, for sharing your experiences with us!

Ajay Sathe

In this edition of our Career Perspectives series, we are delighted to feature Patti Arsenault, Vice President, Quality Assurance, at Cytel. Patti discusses her career in quality assurance, how clinical trials have evolved over the years, balancing regulatory compliance with innovation, and more. After 11 impactful years at Cytel, Patti is retiring, having shaped standards that will guide the organization for years to come.

Can you give us a little background on your career?

I began my career in programming, using Assembler, Fortran, and Cobol, then moved into database and web programming using SQL and Java Script. While working at an epidemiological company, I moved into data management, which felt like a natural next step. I joined Cytel to build the data management team, and later, was asked to step into a quality role. I started at Cytel 11 years ago and have been the Vice President of Quality Assurance (QA) at Cytel for almost 8 years now.

You’ve had a fascinating journey from programming to data management and now leading QA. What motivated each of those transitions?

Each transition felt like a natural progression. When I began my career in programming ― using punch cards! — it was all machine-based communications. But I’ve always been more of a people person, so when given the opportunity to move into data management, the transition was easy.

At my previous company, data managers were also programming SQL within Oracle, and I was part of a team that developed a web-based Electronic Data Capture (EDC) system. During this transition and time, I organized and brought together a disparate group of data managers who had been working independently under different principal investigators, each using their own processes. Bringing this team together and centralizing and standardizing the processes was so much more efficient.

The skills I gathered there ― technology, good communication and organization, team building, and an understanding of client and regulatory needs — were the same skills needed to help Cytel’s quality groups switch from a dispersed setup into a global, unified model.

In your experience improving processes, are there particular questions or mindsets that help you identify what needs to change?

Clinical trial process originally started on paper, and much of what exists today mimics that still. Given that, the key mindset that is needed is being willing to challenge the norm. But that mindset has to be coupled with having the right gatekeepers, people who can ensure that the proposal will be in line with regulatory and client expectations.

This is what is so great about the Cytel QA team. We have a depth of experience that allows us to challenge an existing process and inspect the proposal. We have some great debates about why we do the things we do, and the shared goal of those conversations is always continuous improvement.

When you joined Cytel in 2014, what was your vision for the data management team you were building?

My vision was for the data management team to become well known and trusted in the industry as the best. I was quite excited about building a global team and creating opportunities for team members to learn from each other’s experiences. One of the advantages of hiring data managers at Cytel was the blend of experience we could bring together, both from the sponsor side as well as the CRO side. I wanted to develop the team to have a diverse skillset, making us an adaptable group that brings even more value to our clients.

QA at Cytel touches on so many areas — from GCP to data privacy to customer satisfaction. How do you prioritize and manage such a broad scope?

Yes, our responsibilities span across many domains! This is due to the rapid growth Cytel has experienced. Everyone at Cytel rolled up their sleeves and truly dug in. Through training within the team and assigning a task owner and one to many back-ups, we can manage the broad scope and maneuver tasks amongst the team as needed.

Clinical trials have evolved significantly over the years. What are some of the biggest changes you’ve seen in how quality is managed?

Probably the biggest change I’ve seen is adding risk assessment and an acceptable level of tolerance. It’s a shift that acknowledges that perfection, while always desired, is not always achievable.

Additionally, the speed of acquisition and the types and amount of data have increased substantially. With that comes pressure to complete tasks more quickly, so it is important to strike a balance between efficiency and the quality desired.

How do you balance regulatory compliance with innovation, especially in a fast-evolving field like clinical research?

Regulations rarely tell you exactly how to do something. This allows us to be creative and discuss whether a solution truly achieves the goal of the regulation. We also actively monitor a number of regulatory websites to stay abreast of emerging regulations.

Finally, we welcome our client audits. On average, we conduct about 30 per year. If a client questions an approach they haven’t seen before, it opens a discussion between them and our internal team. These conversations often turn into learning experiences for all involved.

What do you think is the most misunderstood aspect of QA in clinical trials?

Quality assurance is often mistaken for quality control (QC). QA is intended as a proactive approach; we help prevent mistakes or defects. QC, on the other hand, should detect errors after they occur. Of course, using QC data will help us identify processes that are not working as intended!

You’ve built and led your team for over a decade now. What qualities and skills do you look for when building a strong, stable team? And how do you approach supporting junior team members as they grow into their roles?

QA folks need to know how to interpret a regulation, understand a procedural document, communicate clearly, and have a keen sense of organization.

We’ve built some pretty clear growth paths for the QA team. It’s part of my responsibility to work with every team member to find out where they want their career to go, and to help them in realizing that. For those who have the desire to go into auditing, there are multiple steps that you need to be trained in and master as you grow into an auditor role. Some junior team members have, with support, trained in data privacy. For team members who want to be more technical, we have the opportunity to work on the Trackwise application.

How do you foster shared learning across such a diverse QA team?

We maintain a skill matrix where each skill has an owner responsible for training others. We also meet as an entire group on a monthly basis and have people present on a wide range of topics — from regulations to a process or a new, clever way to use Excel. In addition to the monthly full-team meetings, we have several sub-groups such as auditors, change control, computer systems validations, and more, who meet regularly and share ideas, problems, and solutions.

You’ve led some incredible community initiatives like the yearly backpack drive providing school supplies for a local school and providing families with Thanksgiving meals. What drives your passion for giving back, and how do you see these initiatives influencing company culture?

I’ve been fortunate in my life, and I love finding opportunities to help others. A backpack is a small monetary hit for most of us at Cytel, but the impact on a middle schooler who may start school without one is huge!

I believe that people naturally enjoy doing things as a group, to feel part of a group or community. And the feel-good effect of doing good, even if it’s a little thing, builds comradery, which in turn enhances company culture.

Looking back on your 11 years at Cytel, what are you most proud of?

I am proud of our first-rate quality team! We are a dedicated and knowledgeable bunch and try to set the tone of working with the functions and business units rather than policing them. Quality is not an easy role to be in, yet my team comes to work smiling every day.

Finally, when you’re not diving into work, what hobbies or passions keep you busy?

My passion is my family — 3 sons and daughters-in-law and 6 grandchildren keep me busy. I golf and bike and try to be at the beach whenever I can.

Thank you, Patti, for sharing your experience!