We are a highly-motivated team driven to make a difference. At the forefront of what we do is the potentially positive impact our efforts can have on improving the lives of critically ill patients. Our dedicated and talented scientific and management team are amongst the top in the industry, with a long track record of successfully developing novel therapeutics. We strive to foster a collaborative, creative and science-driven environment where our employees can take pride in their accomplishments and where their contributions are valued.
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.
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.
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.
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.
Chimerix is an equal opportunity employer and we take pride in offering a comprehensive benefits package to provide security and financial protection for employees and their families.
If you are interested in learning more about how you can apply to join the team, please contact us at the address below or via our website.
Attn: Human Resources
2505 Meridian Parkway, Suite 340
Durham, NC 27713