We caught up with alum Dr Jacqui Waterkeyn who juggles the demands of two roles – one in clinical research for youth mental health and the other developing products in the commercial sector.
Jacqui heads up the Sponsor Operations Department at Orygen, overseeing all aspects of regulatory and clinical operational compliance under international and national regulatory frameworks.
Orygen works directly with young people, their families and friends to pioneer new, positive approaches to the prevention and treatment of mental disorders.
As Associate Director, her current focus is ensuring Orygen remains up-to-date and compliant with the changing regulatory environment in Australia and overseas.
“There’s a lot of activity and change is on its way, especially post-pandemic. We have to make sure our circa 110 clinical study portfolio seamlessly remains compliant”
In her second role, as Vice-President, Regulatory and Clinical Operations at Stamford Pharmaceuticals/Ascend Biopharmaceuticals, she works closely with the CEO on their product portfolio based around injectable immunotherapy for dermatology-oncology indications.
“In biotech you do everything as your teams are often smaller,” she says.
“The key is to have the knowledge base to drive programs forward and ‘speak-the-speak’ from a real-world experience perspective with your international partners and consultants. The goal? To satisfy all regulatory aspects of product development for successful marketing authorisation.
“I have the two roles as l really enjoy the balance of medical research institutes conducting clinical research and developing products in the commercial sector.
“I’m driven by bridging the knowledge and expertise gaps between the commercial and academic research environments in order to drive innovation and clinical translation.”
The initial move from academia to industry was a difficult decision for Jacqui back in 2000. “When I moved into industry, it was seen as ‘going to the dark side’. At the time, I was trying to convince my research colleagues that there really was more to industry than becoming a sales rep!”
Her first role was in Regulatory Affairs with CSL, harnessing her scientific background for new therapies for patients or as prophylaxis such as vaccination. She quickly began to understand and appreciate the drug development process and what regulatory agencies needed and expected.
Following her commercial experience, Jacqui played a pivotal role in launching Nucleus Network, now Australia’s largest Phase 1 clinical research organisation.
Her unique combination of regulatory affairs and clinical operations have been instrumental in connecting her expertise to other areas of the sector such as legal, intellectual property, research governance and ethics.
“Nowadays, there are many industry avenues you can enter. You just need to know what they are to pursue them,” she says.
“My advice would be ask your contacts who and what they know. People know people and contacts can put you in touch with others to help understand the types of roles available and what they entail and whether they are right for you.”
“Don’t be shy – you’ll find people are genuinely happy to help.”
Over the years Jacqui has mentored and assisted many people seeking to transition to industry, and proudly notes that many of the friends, colleagues and contacts who she’s helped along the way have progressed to successful careers in the sector.
“You can’t ask a WEHI alum about their time at the Institute without mentioning vegemite saladas at morning tea. If I wasn’t culturing malaria at 10:30, I was upstairs munching. What was especially nice was how your colleagues would come around to your bench and pick you up to go to morning tea, or you went to them.
“You could get information from so many sources, colleagues and friends – it was really sociable. And you meet so many people that you naturally form close friendships with like-minded people which stick for life. We are all in different parts of the world now, which makes it even better,” says Jacqui.
Her most unforgettable times at WEHI were overnight assays looking at protein trafficking. “I won’t say it was fun, but it was definitely memorable! Twenty-four hours is a long time to stay awake and continue to process bio samples.
“These nights were organised with another PhD student so we’d keep each other awake and make sure we made our next timepoint. We brought food and entertainment but I can tell you, 3am in the lab was not the greatest time of day.
“I was super thankful to my lab head, Professor Alan Cowman, when he arrived to do the 7am timepoint and I could go home to sleep.”