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 email@example.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).
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.
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.
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
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.
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.
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.
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.
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.
The incumbent will give legal counsel and provide support for our Research and Drug Development team. Candidate will draft, review, and negotiate agreements for clinical trials, licensing, material transfer, research, consultant, confidentiality and nondisclosure, as well as other service and vendor agreements. Interpret contracts and provide resolution. Draft, review and negotiate common pharmaceutical industry commercial agreements and other corporate agreements. Provide legal advice and assistance for the development of policies and training, and conduct training. Represent the company externally to customers, suppliers, competitors or government agencies. Resolve legal issues using negotiation skills and legal expertise.
JD required. Minimum 1-3 years experience within a major law firm and/or in-house legal setting. Experience in the pharmaceutical and biotech industries preferred.
Drives the monthly close process to meet internal and external deadlines. Ensures reports are accurately prepared to meet defined review timelines by management and explains trends and/or fluctuations. Coordinates month-end, quarter-end and year-end reporting, prepare accruals and schedules. Submits monthly and ad hoc financial reporting packages. Analyzes and reviews the organization's financial performance by collecting and understanding the financial reports and statistical data. Oversees relevant Sarbanes-Oxley requirements and all SEC reporting.
Bachelors of Arts degree in Accounting or other related discipline, MBA preferred. 10+ years of experience in an Accounting or Finance capacity. Expertise with SEC reporting required. CPA certification a plus.
NDA Submission Manager
Responsible for driving the successful, timely submittal of all NDA submissions to the appropriate regulatory authorities. The selected individual will create, maintain, and execute the regulatory submission plan (utilizing MS Project) through the indirect management of a multidisciplinary team. Will prepare routine progress reports, facilitate the sharing of information across departments, and ensure project visibility throughout the organization.
Minimum of 5 years of direct experience submitting NDAs in an eCTD format. Working knowledge of MS Project. Ability to work independently while providing timely status reports to senior management. Bachelor’s degree required.
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