Parexel has kept its foot on the gas for new hires as it has grabbed a triumvirate of global regulator execs.
The three are: Yajie Li, M.D., who joins Parexel after being a senior clinical reviewer with the Center for Drug Evaluation (CDE) in Beijing; Jorge Camarero, Ph.D., who has served at the European Medicines Agency (EMA); and a veteran of the FDA’s Center for Drug Evaluation and Research (CDER) and the National Institutes of Health (NIH), Lucas Kempf, M.D.
At the CDE, Li led and managed the clinical evaluation of studies and long-term development plans for chemical and biological products. She was most recently vice president and head of compound strategy and pipeline management functions at Xuanzhu Pharma, and she served a stint at Janssen for its regulatory affairs.
Camarero, meanwhile, has a focus on oncology, having served at the EMA in the Netherlands as an alternate member of the Committee for Medicinal Products for Human Use and as a member of the Oncology Working Party.
Kempf was the CDER’s acting associate director of its rare diseases program. He also formerly worked at the National Institutes of Mental Health with a focus on genetics and neuroimaging.
The new hires will serve as “technical vice presidents” and essentially will use their insider regulatory and life science experience to help Parexel’s clients through the regulatory process, “including navigating rapidly evolving landscapes related to regulatory meetings and submissions, compliance and market access,” according to a statement from the CRO.
“The global pandemic has created a highly dynamic regulatory environment as companies adapt quickly to protect patients, preserve supply chains and maintain focus on new emerging therapies,” said Paul Bridges, SVP, regulatory and access.
“Parexel remains committed now, more than ever, to helping our customers address the rapidly evolving regulatory changes through a strong roster of former regulators and regulatory experts. Our new colleagues bring first-hand experience from their tenure working within global health authorities to help our customers seamlessly navigate the regulatory process and ultimately help deliver new therapies to patients.”
A year ago, Parexel nabbed Gavin Nichols as its EVP of informatics and IT; he joined from Bioclinica, where he was chief information officer and EVP of technology. Before that, he had spent more than a decade at Quintiles (now IQVIA).
At the start of 2019, Parexel also went on a small hiring spree, snapping up a series of former FDA staffers including Amy McKee, M.D., who in February became its new lead to help build up the company’s oncology initiative. She was previously deputy director at the FDA’s Oncology Center of Excellence on its regulatory consulting team.
This comes as Parexel moved back to becoming a private company after its buyout from Pamplona in 2017 and with a new CEO in Jamie Macdonald, after its co-founder and major three-decade-plus veteran Josef von Rickenbach retired in 2018.