January 16, 2020 at 04:31AM
Join a company that’s making a difference in the fight against cancer. Astex Pharmaceuticals, http://www.astx.com, is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology. Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan. We are looking for an experienced and motivated professional interested in applying their unique skills to our shared mission. This position will be based in our office located in Pleasanton, California near the Dublin-Pleasanton BART station in the Rosewood Commons campus: https://ift.tt/2I1xMDb The Clinical Trial Manager partners with the Astex Clinical Operations staff and other departments to ensure that Astex clinical trials are conducted in accordance with corporate Standard Operating Procedures (SOPs) and Guidelines, Good Clinical Practices (GCP), ICH Guidelines and applicable federal and national regulations (FDA and EMEA). This role can be either contract or direct hire. Responsibilities : Manage studies within a program with minimal supervision Assist in the preparation of safety, interim, and final study reports Assist in site selection, study implementation and ongoing management of study sites either directly or via service providers Participate in forecasting study drug supply requirements and managing logistics Manage and maintain CRO/service provider relationships Coordinate and/or participate in Investigator meetings Train study coordinators and investigators on Good Clinical Practice/ICH and Astex processes Participate in the development of best practices for Phase 1-3 study management Determine methods and procedures on new assignments with minimal supervision Travel: Up to 25% Qualifications: BA/BS in a relevant scientific discipline Minimum 2-5 years’ related clinical trial management experience in the pharmaceutical industry or equivalent; oncology experience is highly desirable Exceptional oral, written, interpersonal, and presentation skills Proficiency using Microsoft Office Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials Ability to prioritize multiple tasks, plan proactively, and accomplish goals within timelines Ability to develop tools and processes that increase measured efficiencies of the project Strong attention to detail and meticulous follow-through in a fast-paced environment
About Aspex Pharmaceuticals
Astex Pharmaceuticals, Inc. was formed through the merger of Astex Therapeutics Limited (UK) and SuperGen, Inc. (US) in 2011. The company was subsequently acquired by Otsuka in October 2013.
Astex Technology Limited was formed in 1999 in Cambridge, UK, and was a pioneer in the development of fragment-based drug discovery technology. Astex was backed by leading venture capital firms, and established multiple partnerships with major pharmaceutical companies including AstraZeneca, Novartis, Janssen and GSK to use the company’s drug discovery platform, PyramidTM, to identify novel small molecule drugs addressing key disease targets.
SuperGen, Inc. was formed in 1991 in Emeryville, California, and was the developer of Dacogen® (decitabine) for injection, now sold by Otsuka Pharmaceutical in the USA, and by Janssen in over 40 countries outside of N. America and Japan. Dacogen® is indicated for the treatment of intermediate-high risk myelodysplastic syndromes in the US, and for the treatment of elderly (>65 years) patients with acute myeloid leukemia (AML) in the European Union.