Chimerix

Opportunities

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 hr@chimerix.com.

 

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).

Qualifications:

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.

Qualifications:

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.

 

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.

Qualifications:

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.

 

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.

Qualifications:

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.

 

Medical Director

Assume responsibility for correct and updated scientific and medical information for the respective therapeutic field. Assure medical/scientific integrity of clinical trials and of both internal and external contacts related to therapeutic program. Provide training and ongoing input to all members of the Clinical Subteam and Core Team on medical issues related to the therapeutic field in question. Assess and interpret trial results.

Qualifications:

Medical degree required. At least 5 years practical experience in clinical specialty (oncology/critical care/transplants/anti-virals) with International experience preferred.

 

Associate Director, Medicinal Chemistry

Design and synthesize small molecule drug candidates. Conduct retrosynthetic analyses, forward syntheses, and troubleshoot reactions. Characterize compounds using analytical instrumentation such as HPLC, LC/MS, and NMR. Assist in the planning and management of external research efforts for contract research organizations and collaborations

Qualifications:

Ph.D. in medicinal or synthetic chemistry with 3 to 5 years of relevant industry experience. Previous nucleoside experience is required. Experience in developing structure-activity relationship data to drive projects forward. Prior biotech or CRO experience required.

 

Manager, Analytical Development

Contribute to selection, oversight, and management of CDMO's. Manage projects to maintain timelines and financial restraints. Design and review drug substance and product testing protocols for validation and stability. Understand and use USP, cGMP, and FDA guidelines to assess data in reports. Expected to contribute and collaborate with related functions (Chemical Development, Toxicology, Virology, etc.). Critically review, tabulate, and manage data.

Qualifications:

BS/BA in Chemistry, Biology, or related Science field. 5 years prior experience in a pharmaceutical field. Understanding of regulatory requirements. Direct experience and understanding of the drug development process as applicable to pharmaceutical, chemical, and/or analytical development. Prior bench experience with HPLC, MS, and other classical analytical techniques.

 

Regulatory Operations Manager

Responsible for formatting, publishing, and submission of regulatory documents in eCTD format. Ability to coordinate of submissions both independently and in a team setting within specific timelines. Provide regulatory submission support to other departments with minimal supervision.

Qualifications:

BS/BA in related field. 7 years prior experience in a pharmaceutical field. Comprehensive knowledge of ICH CTD and evolving global agency publishing standards. Extensive knowledge and skills related to publishing systems processes and standards. Understanding of IND and NDA life cycle and maintenance requirements.

 

Principal Scientist

Determine EC50 and CC50 values of compounds against viral targets. Maintain virus stocks and cell cultures; determine titers and TCID50s. Perform cell biology and molecular biology assays.

Qualifications:

BS/BA in Biology or related science field. At least 10 years previous experience in the pharmaceutical industry developing and running virology assays. Proven record of success with tissue culture and molecular biology. Knowledge of viral pathogens and drug development.

Our Vision

Improve human health by developing important new antiviral medicines to treat life-threatening diseases.


Commitment

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