The incoming Radiation Safety Officer (RSO) will be responsible for the support of the company’s radiation-related communication with clinical sites, assessment of clinical development and commercial feasibility, and ad hoc corporate development projects. The RSO will provide effective leadership, communication, and representation to the outside Radiation Safety community by forming strong relationships and exhibiting a presence at academic community events. The successful candidate will independently manage the site relationships in collaboration with the clinical development program(s). He/She will perform assigned responsibilities to ensure project deliverables are met in accordance with the departmental goals and objectives, and will assist with special projects as assigned including additional clinical trials. Specifically, the Radiation Safety Officer will: - Direct hands on training and management of the clinical sites for the existing and upcoming clinical trials - Responsible for the accumulation of feasibility information relating to individual clinical sites for handling radiopharmaceuticals - Prepare and maintain study budgets, timelines, and project plans for nuclear medicine and radiation safety oversight at the sites - Interacts with the regulatory department to assist and review in global trial submission documents. Assist in the preparation and review of documents/ correspondence for regulatory agencies (e.g., FDA Reports, response to inquiries, data submissions). Participate in the preparation of NDAs, sNDAs, etc. - Collaborate with product development teams to ensure drug supply transport, manipulation, and administration is optimally and safely executed - Participates in the periodic review and revision of departmental policies and SOP’s to assure compliance with corporate policies and good clinical practice procedures (GCP’s). - Maintains knowledge of U.S. and foreign regulations, guidelines, policies and practices for conducting global clinical investigations with radiopharmaceuticals.
Board certification- ABR, ABMP or CHP Understanding of Radiopharmaceutical Therapy Strong ability to communicate and explain aspects of radiation safety and radiopharmaceutical therapy to varied audiences Teaching background preferred Background in nuclear medicine and in nuclear medicine departments in hospitals, including familiarity with dosimetry methods Experienced in shielding calculations Effective verbal (including listening) and written communication skills. English language required. Ability to work independently and as part of a team Strong planning, organizational and leadership skills Results orientation. Strong initiative, accountability and willingness to take ownership and drive projects to completion
Actinium Pharmaceuticals, Inc. is a publicly traded biopharmaceutical company developing innovative targeted therapies for patients with cancers lacking effective treatment options. Actinium's proprietary technology platform utilizes monoclonal antibodies to deliver radioisotopes directly to cells of interest in order to kill those cells safely and effectively.
The Company's lead product candid...ate, Iomab-B, is licensed from the Fred Hutchinson Cancer Research Center and is designed to be used, upon approval, in preparing patients for a hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. A bone marrow transplant is often the only potential cure for patients with blood-borne cancers but the current standard preparation for a transplant requires chemotherapy and/or total body irradiation that result in significant toxicities. Actinium believes Iomab-B will enable a faster and less toxic preparation of patients seeking a bone marrow transplant, leading to increased transplant success and survival rates. The Company is currently conducting a single pivotal 150-patient, multicenter Phase 3 clinical study of Iomab-B in patients with relapsed or refractory acute myeloid leukemia (AML) age 55 and older. Learn more about Iomab-B and bone marrow transplant for AML here.
In addition, Actinium is developing, Actimab-A, its lead alpha-particle drug candidate that is licensed from Memorial Sloan Kettering Cancer Center. Actimab-A is currently in a multicenter open-label, 53-patient Phase 2 trial for patients newly diagnosed with AML age 60 and over. Actimab-A is being developed to induce remissions in elderly patients with AML who lack effective treatment options and often cannot tolerate the toxicities of standard frontline therapies. To learn more about Actimab-A visit this link.
In addition, Actinium has expanded it alpha-particle approach with its newly created drug candidate Actimab-M, which is being studied in patients with relapsed or refractory multiple myeloma in a Phase 1 clinical trial.
Actinium is also utilizing its alpha-particle immunotherapy (APIT) technology platform to generate new drug candidates based on antibodies linked to the element Actinium-225 that are directed at various cancers that are blood-borne or form solid tumors. To learn more about Actinium's APIT or to explore a potential collaboration using this powerful technology please visit the Technology page.