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.
Authors and manages narratives for CMC sections to support regulatory filings in conjunction with CROs, CDMOs and internal sources.
Critical review of documents associated with development and commercial manufacturing, packaging and distribution.
Contributes to selection and management of CDMOs and CROs.
Bachelor’s degree and 5 years prior experience in the pharmaceutical industry. Experience with projects involving contracted services in both pharma and biotech is preferred. Knowledge and experience writing documents for FDA submissions in support of IND and NDA filings. Familiarity with eCTD is mandatory. Direct experience and a detailed understanding of the drug development process as applicable to pharmaceutical, chemical, and/or analytical development. Detailed knowledge in some aspects of drug development (i.e. formulation, process chemistry, analysis, or process validation).
Serve as primary liaison with Contract Research Organization maintaining the Chimerix Global Safety Database, working with clinical sites enrolling ongoing clinical trials to manage the site training, reporting, follow-up and generation of narratives for SAEs.
Organize, manage and actively carry out as appropriate, local PV activities, such as adverse event monitoring, safety reporting, risk management, inspection preparedness and any other required country-specific safety activity.
Work closely with Regulatory managers to ensure proper collection, on-time reporting and quarterly summaries of SAEs.
Registered Nurse and minimum 4 years’ experience in pharmacovigilance and/or data management, clinical care, or clinical or scientific research required. Solid knowledge of pharmacovigilance concepts, national and international regulations, medical terminology and global regulations/guidelines for drug development.
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.
Director, Clinical Pharmacology
Responsible for design, conduct, analysis, interpretation, reporting and presentation of clinical pharmacology studies for products under development. Studies may include first-in-human, proof-of-concept, drug interaction, special population, bioequivalence, mass balance and QT studies. Construct PK analysis plans for Phase 2b/Phase 3 studies and participate in population PK analyses and interpretation.
Responsible for overall time and content of clinical pharmacology program to satisfy regulatory expectations.
PharmD or PhD in pharmacokinetics with at least 7 years relevant clinical development/clinical pharmacology experience in industry. Experience as lead clinical pharmacologist with success at defending clinical pharmacology data and programs to regulatory agencies. Demonstrated knowledge of related development disciplines such as toxicology, DMPK, clinical development and CMC.
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.
Clinical Project Assistant
Associate or Bachelor degree or relevant experience in a health related field preferred; three to five years’ experience in a clinical development environment preferred. Preferably knowledge of Good Clinical Practice (GCP) and ICH guidelines, FDA and/or EU guidelines.
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