Chimerix, Inc. is a growing company and always seeks talented individuals to help with its advanced drug development programs.
If you are interested in learning more about Chimerix, please send cv/resume to firstname.lastname@example.org.
Associate Clinical Project Manager
Participate and contribute as an innovative project team member supporting and facilitating the management of one or more global clinical trials in accordance with GCP/ICH guidelines and local/country regulatory requirements. Accountable to provide quality and effective document management support for the clinical research and operations departments. Establish and maintain clinical records and appropriate file structure. Work closely with other internal functional departments and external vendors to coordinate and facilitate the review, revision, and establishment of clinical standard operating procedures and processes as required per the established scope of work(s).
B.S. in a health-related discipline or an RN or other nursing degree with experience or Associates degree in clinical research with experience or High School Diploma with 7+ years experience in the drug development industry. A minimum of 5 years experience in a pharmaceutical company or CRO is required.
Senior Clinical Project Manager
Responsible for all aspects of one or more global clinical trials from the preparation, execution, and reporting associated with clinical trials in accordance with GCP/ICH guidelines and local/country regulatory requirements. Facilitation and coordination and full project management responsibility for multiple global clinical trials including organization of RPFs to vendor selection, establish tracking and management of scope of work and associated budgets and timelines. Lead the clinical project team to ensure clear, accurate and timely information flow between members and other functional departments. Accountable for leading the clinical project team to deliver the clinical trial(s) within planned timelines and budget in full accordance with required standards of quality and compliance.
B.S. degree or higher (or its equivalent) in a life science/biological or health related field preferred. Five or more years experience of full project management and budget responsibility for multiple trials (either consecutively or simultaneously) as a Clinical Trial Manager. An overall minimum of 10 years experience in a pharmaceutical company or CRO is required.
Senior Clinical Research Scientist
Write and prepare clinical submission documents within a team environment.
Ability to provide critical review and interpretation of clinical data based on relevant Company Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
Provide process, content, and planning expertise to Clinical Trial Team regarding document preparation, submission strategy, data collection and interpretation and consistent scientific messaging. Advise team on Medical Writing resource utilization, efficiencies, timelines, and interdependencies. Oversee preparation of clinical submission documents for a project; review and provide feedback on clinical submission documents to maintain consistent content, messaging, and style.
Bachelor’s Degree with eight or more years of pharmaceutical industry experience or Master’s Degree with five or more years of pharmaceutical industry experience with a proven successful track record in clinical development. Experience in clinical trials, Phase 1 – 4. Sound knowledge of ICH guidelines, an understanding of the regulatory requirements from EU and US health authorities and of the submission process, including participation in NDA submissions. Excellent knowledge of regulatory writing.
Regulatory Operations Associate
Responsible for the collection, scanning, electronic filing, and submission preparation of references and publications for paper and/or electronic submissions. Provide QA/QC support for electronic submission documents and deliverables. Responsible for data entry, filing, archiving, and maintenance of submission tracking databases. Format MS Word documents by applying appropriate templates, styles and formatting techniques to documents.
BS/BA degree required with one year of applicable experience in the pharmaceutical industry. A thorough understanding of electronic document management software. Efficient in Microsoft Office Suite (Word, Excel, PowerPoint and Outlook) and Adobe.
Improve human health by developing important new antiviral medicines to treat life-threatening diseases.
Chimerix was founded with the aim of radically improving the way viruses are treated. We initially saw an opportunity to combine a known antiviral with an intriguing technology to create a new treatment option for smallpox, historically one of the greatest viral threats to humankind. As we learned more about CMX001, we have seen its potential across numerous applications. Read More