We’re more than just founders of the company, we’re really good friends. We work well together because we genuinely like each other and greatly admire each other’s professional experience, skills and talents. We’re a dynamic, multifaceted team with a common goal – to serve our clients better than anyone else through every step of the process.

Director of Clinical Operations – Ron Carozza, PharmD
Director of Clinical Development – Gary Jones, MD
Director of Regulatory Affairs – Margaret Warner-Lubin, CCRA

Ron Carozza, Pharm.D.
Director of Clinical Operations

“Early on in my career, I had the chance to work on an exciting new leukemia drug. I worked on the Phase I and Phase II studies and followed the drug through FDA approval. I was hooked – I love the drug development process.”

Originally an Oncology pharmacist, and 14 years into working in the biotech-pharmaceutical industry, Ron saw a need for a clinical research regulatory and quality assurance specialist group particularly for small to mid-sized companies looking to undergo the clinical trial process. He envisioned a small, powerful company of heavy-hitting industry professionals eager to provide a clear, guided pathway through the clinical trial process specifically tailored to companies who would otherwise feel lost or underserved working with a very large CRO with competing priorities due to a multitude of larger clients. He sees each client’s project being nurtured along individually, like a single precious egg, rather than just one among many in a basket full of eggs.

“I prefer working with smaller companies. It’s a fun, fascinating industry and I love being right there, able to talk with the clients and help them through the clinical trial process personally.”     back to top

Gary Jones, MD
Director of Clinical Development

“I love helping get innovative ideas through the “valley of death” after they’ve “cured every cancer known to mouse.” I love helping get that compound into and through the clinical trial process and into the marketing process to truly help people.”

As Director of Clinical Development, Gary uses his 20 years of experience and expertise, accumulated through his careers in academia, medical care, and clinical research, to enjoy direct involvement in the clinical development of both medical devices and therapeutics that address medical needs not currently being met.

“I’ve always been fascinated by the chemistry of life and by the many aspects and manifestations of what happens when the chemistry of life goes wrong.” Especially interested in “pushing the boundaries of the box” of clinical development in oncology, he is directly involved in the aspects of both development and running of clinical trials, interpreting results and moving aspects of data forward in a practical way to bring therapeutics to the market that help people with critical needs in any area of medicine.

“I enjoy having a front row seat to what’s being developed by a multitude of companies, not just one company. Within a controlled, confidential, professional environment, I have the opportunity to see a whole variety of different, innovative compounds and devices being developed. Science and innovation!”      back to top

Margaret Warner-Lubin, CCRA
Director of Regulatory Affairs

“It’s an addicting industry, a passionate industry. With clinical trials, you work on a project with a client for a long time, and you want it to succeed and get to the patients.”

With over 16 years experience, Margaret’s passion for clinical research has brought her to deeply understand the bio-tech and pharmaceutical trial industry. This broad variety of firsthand experience gives Margaret an extraordinary perception of the entire clinical process as seen from the sides of the client, the funder, and the manufacturer.

Every client and project of C3 has a unique process with unique needs. As the Director of Regulatory Affairs, Margaret enjoys finding a responsive, creative solution for every individual project, facilitating clinical efficiency in a budget conscious, consistent, personalized manner with the ultimate endeavor being to support consistent client success.

With international and global health experience in Europe, Eastern Africa and Southern Africa, Margaret has worked on both small and large-scale IND (FDA regulated) and non-IND trials, which required both flexibility and innovation to conduct in their unique settings. With more than 16 years of experience managing multi-center clinical trials, spanning small oncology studies of 5-20 subjects to large infectious disease studies of over 7,800 subjects, Margaret has also successfully managed Phase I-III clinical trials for clients ranging from small companies to large academic institutions.

For 4 years, Margaret’s responsibilities included being the Clinical Research Operations Manager of 2 large, randomized controlled studies for HIV patients in Eastern and Southern Africa and the United States. This included managing complex operational and regulatory aspects of the studies from assessment of site capacity to overall coordination of clinical data management, monitoring and laboratory activities, ensuring that all respective regulatory requirements were met.

“It’s not always clear, but there are pretty simple, broad regulatory guidelines to follow, and there’s a path that allows for some creativity. I like to create a hybrid solution that fits within the range of the guidelines and best supports the client’s needs.”      back to top