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Position Summary. Lead the planning, execution and completion of assigned regional/global clinical studies, ensuring alignment of activities with study timelines, budgets, SOPs, GCP, ICH and applicable regulatory guidelines, as well as compliance with assigned protocols. Serve as clinical operations leader for assigned project(s) in driving cross-functional team(s) to execute on regional/global clinical studies by partnering and collaborating with internal and external team members. Provide direction for Clinical Operations staff as well as contractors/vendors/CROs involved with applicable stu... view job details
Position Summary. We seek a highly motivated Associate Scientist/Scientist to work with the Protein Chemistry group to make impactful contributions to drug discovery projects targeting disease areas with high unmet medical need. The successful candidate will operate in a highly diverse and dynamic research environment supporting early research and drug discovery programs through the expression, purification and characterization of high-quality recombinant proteins and antibodies. This position reports to the Director of Chemistry. Responsibilities. Transformation, expression and purification o... view job details
Position Summary. The Manager, Regulatory Affairs will contribute to the Regulatory Affairs department in the maintenance of global Phase 3 clinical trials and NDA registration. The RA manager will represent Regulatory Affairs on cross- functional project teams and provide regulatory support and guidance regarding overall regulatory strategy to ensure high quality submissions in compliance with global regulations and guidelines. The RA manger will be responsible for reviewing the content of regulatory submissions (INDs, CTAs, NDA/MAA), briefing books, clinical protocols and nonclinical repor... view job details
Position Summary. Primarily responsible for support of the regulatory team. With direction, coordinates, complies, reviews and prepares document packages for high quality regulatory submissions. Executes administrative work of the regulatory department and processes to ensure quality and compliance. Responsibilities. Provide MS Word processing support for preparation of regulatory submission documentation. Provide Adobe PDF processing support for preparation of regulatory documentation and submissions. Responsible for updating Regulatory and Health Authority correspondence log. Responsible f... view job details
Position Summary. Animal Technician to conduct. in vivo. studies in mice at our local vivarium. The successful candidate will be required to work with BSL2 level infectious agents. This position also requires some laboratory work outside the vivarium, at Cidara’s main lab, processing samples for in vitro analysis. This position will directly support our Cloudbreak antiviral program by providing critical PK/PD and efficacy data to support compound development activities. Position reports to Senior Director, Preclinical Development, and works closely with the Senior Animal Technician. Respons... view job details
Position Summary. The SEC Reporting Manager will be responsible for preparation and filing of all external financial reporting documents and related SEC filings. The position requires that the candidate be a hands-on professional with a strong understanding of the application of Generally Accepted Accounting Principles (GAAP) in a public company environment, experience managing and accounting for equity incentive plans, and strong interpersonal skills. A SOX-compliant mindset, strong leadership, analytical, and problem-solving skills, and desire and ability to identify, recommend, and lead i... view job details
Position Summary. Responsible for Trial Master File (TMF) quality per ICH GCP guidelines. Prepare, process, and track documents received (paper and electronic), per project requirements, in a timely manner. Ensure that documents are scanned, imported, coded, and indexed into the Trial Master File (paper, electronic, or both) and reviewed for quality on an ongoing basis. Implement internal quality control (QC) checks of CRO and vendor TMFs as well as internal TMFs, as applicable. The primary responsibility will be to ensure that all TMFs are submission and inspection ready on an ongoing basis. ... view job details
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