[비즈한국] SK Biopharmaceuticals is strengthening its global clinical development capabilities for Radiopharmaceutical Therapy (RPT). The company is accelerating its preparations for global clinical trials, centered in the U.S., by hiring high-level professionals at its American subsidiary to manage clinical strategy and operations for RPT.
According to industry sources on the 14th, SK Life Science, the U.S. subsidiary of SK Biopharmaceuticals, is recruiting for a "Director/Senior Director, Clinical Operations" position based in Paramus, New Jersey. This role involves overseeing global clinical operations for radiopharmaceuticals, radioligand therapy (RLT), and complex oncological clinical trials.
The job posting specifies that the role covers everything from establishing RPT clinical operation strategies to executing clinical trials, managing Contract Research Organizations (CROs) and specialized vendors, and overseeing budgets, schedules, and risk management. In particular, it includes tasks specialized for RPT clinical trials, such as radiopharmaceutical supply and transport, preparation of nuclear medicine clinical trial sites, radiation safety, imaging and dosimetry, and the collection, processing, and transport of radioactive blood and urine specimens.
Qualifications also demand expertise in the RPT field. The company requires at least 10–15 years of clinical operations experience, including at least 5 years of experience related to radiopharmaceuticals. It also offers preference to candidates with experience in clinical development programs focused on radiopharmaceuticals, RLT, nuclear medicine, oncology, theranostics, and imaging.
Compared to typical drug trials, RPT clinical trials require specialized capabilities, including the supply and transport of radioisotopes and radiopharmaceuticals, radiation safety, nuclear medicine facility preparation, imaging, dosimetry, and the handling of radioactive specimens. This recruitment drive is interpreted as a move to secure these specialized RPT clinical operation capabilities.
An official from SK Biopharmaceuticals stated, "Kim Ki-il, Head of the RPT Division at SK Biopharmaceuticals, is overseeing the overall clinical and business aspects," and added, "We are recruiting talent in the U.S. to establish our overarching RPT clinical strategy."
This recruitment is seen as part of SK Biopharmaceuticals' process of concretizing the global clinical development of its RPT business. In particular, the focus on securing Director/Senior Director-level personnel with RPT clinical experience—rather than general clinical operations staff—is interpreted as a move to strengthen expertise for future global clinical operations.
SK Biopharmaceuticals is cultivating RPT as its next-generation growth engine. Starting with the acquisition of RPT candidates from Full-Life Technologies in July 2024, the company has been sequentially securing its pipeline while simultaneously building a radioisotope supply chain. It has established a foundation for securing core raw materials by signing Actinium-225 supply agreements with companies such as TerraPower (U.S.), PanTera (Belgium), and Eckert & Ziegler (Germany).
In January, SK Biopharmaceuticals received approval from the U.S. Food and Drug Administration (FDA) for Investigational New Drug (IND) applications for its RPT candidate "SKL35501" and diagnostic imaging candidate "SKL35502." The company has also submitted identical clinical trial plans to the Ministry of Food and Drug Safety in South Korea and is currently undergoing review.
SKL35501 is an alpha-nuclide-based radiopharmaceutical therapy targeting NTSR1. It is designed to attack tumor cells expressing NTSR1 using high-energy alpha particles emitted from Actinium-225 (225Ac). SKL35502 is a candidate that uses Indium-111 (111In) to visualize NTSR1-expressing tumors.