Tell us about your first role in the field of clinical research.
The transition from medical research to semi-clinical research was a challenge for me. I was given a role introduce PET radiopharmaceuticals for clinical use in the mid 90’s that encompassed management responsibility for their manufacture, quality control and obtaining ethics approval to conduct a number of small clinical trials.
When I started my position, I didn’t have the right skill-sets for the role, and had to learn on the job. The first task was to understand how to make PET radiopharmaceuticals which resulted in re-designing their sterile manufacturing suites, quality processes and a GMP licence to ensure what we made was reproducible and met the required standards. I used this data to create IBs for each PET radiopharmaceutical covering chemistry, preclinical and clinical matters to support submissions to ethics. It was a positive but a very hands-on experience.
You have rich experiences in various roles, from Regulatory Affairs, Medical affairs, Medical safety, Promotional review, Medical information, Reimbursement to Quality and Compliance, which role did you enjoy the most?
All the roles were testing and rewarding. My greatest personal experience came from those roles I started from scratch as the company wanted to offer these services internally and externally. However, there was no resource available to provide guidance on how this could be done. I remember one instance where globally the company decided that specific local affiliates needed to be ISO 13485 certified, but no one internally understood how this could be achieved and what an ISO auditor would require. In the end, I managed to obtain the ISO certificate and it was a great outcome for the company as well as for me personally.
How and when did you first cross paths with GreenLight Clinical? What is the GreenLight Clinical journey like so far?
Dr. Sasi Suda and I previously worked together. I recall hearing that Dr. Suda had teamed up with a prominent VR surgeon and had established a CRO operating out of Sydney. It sounded very exciting and challenging after learning their business model and vision.
To this day, I still find working at GreenLight Clinical stimulating and I enjoy the everyday challenges and growing with the company. What I love about GreenLight Clinical is its people; their genuine commitment and support to each other, getting the job done to the best of their ability. They have my utmost respect and it’s a pleasure working alongside them.
You are leading the Clinical Services in GreenLight Clinical, what is your leadership philosophy?
It’s about empowering the team to make the best decision with the information at hand. I encourage my staff to be proactive and always look for opportunities to manage trials efficiently. Underpinning this philosophy is the need to embrace change. The demands and expectations of clients and regulatory agencies are in a constant flux, thus we need to adapt to the variety of changes quickly.
In GreenLight Clinical, you oversee departments of Biostatistics, Data Management, Logistics and Regulatory Affairs, how unique are these teams compared to other global CROs?
GreenLight Clinical may be a young start-up company but it is equipped with an experienced in-house team. Many global CROs rely on outsourcing their services to external third parties. Our team is dedicated to providing the best solutions for our clients. We take a unique approach that put clients’ interests first.
While GreenLight Clinical is fast expanding its global footprints, our people aspire to be adaptive and innovative. I am very impressed by the high-quality output we deliver, and I am proud to manage such a flexible and committed group of specialists.
With GreenLight Clinical as a Global CRO, how do you ensure all teams are working cohesively and are meeting compliance, regulatory and policy requirements?
I believe transparency is the key. It helps employees stay engaged and be on board with the strategic direction of the business. Furthermore, it is essential to provide clear guidance and advice so the work we do meets regulatory requirements.
What are you learning or finding challenging in your role right now?
My role covers a range of responsibilities and skill-sets. However, I cannot be the subject matter expert across all these facets. It’s a balance between leading the high-level strategic direction while empowering my team to manage the detail where they are the leading experts. However, I am fortunate that I have a variety of specialists to lean on where everyone strives for continuous improvement.
What are the factors that separate GreenLight Clinical from its competitors?
One of GreenLight Clinical’s strengths is that it has a cohesive and collaborative culture. I am pleased to be surrounded by passionate and versatile teams that can combine to provide tailored solutions that suit clients’ needs. And finally, we are physician and clinician-led with in-house experts and we are proud to have our own central laboratories that can accommodate global clinical trials.
Over the last 12 months, GreenLight Clinical has experienced phenomenal growth; what is your management strategy that enables your team to excel while continuing to support the growth of the company?
Fundamentally, it’s all about our people. In addition, improving their skill-sets, and making sure they feel comfortable to ask questions is important. Moreover, aligning our delivery to GreenLight Clinical’s strategic direction is my team’s key focus.
Finally, strong leadership comes from making unified decisions as a management team, whether requiring prior consultation or not, we are ultimately responsible for the implications of these decisions.