Please Enable Cookies to Continue
Please enable cookies in your browser to experience all the personalized features of this site, including the ability to apply for a job.
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 clinical development and management teams are among the best in the industry, with long track records 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.
We’re centered on our five core corporate values, and we look for potential employees who embody the same ideals.
Our Five Core Values
1. Make commitments and live up to them
2. Leverage scientific ingenuity
3. Hold ourselves to the highest standards of ethical behavior
4. Embrace unique talents, honoring diverse life and work styles
5. Promote an environment of trust
Chimerix, Inc. is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class. Consistent with our commitment to equal employment opportunity, Chimerix provides reasonable accommodations to qualified individuals with disabilities who need assistance in applying electronically for a position, unless doing so would impose an undue hardship. To request a reasonable accommodation for this purpose, please send an email to firstname.lastname@example.org or call 919-806-1074.
Click column header to sort
We are currently seeking a experienced Associate Director/Senior Clinical Project Manager. The selected individual will serve as a member of our Project Management team to manage the timelines associated with the clinical development of compounds. Thorough knowledge of the intricacies of clinical trails will be required-- this is a senior level role within our team.
- Coordination and project management responsibility for clinical trials, including organization of the trials, tracking and management of budgets and timelines
- Work with Regulatory or other appropriate team members on responses to questions occurring during the regulatory approval process of a trial or during the trial (by competent authorities, Independent Ethics Committees (IECs)/Institutional Review Boards (IRBs)
- Ensure that Clinical Trial Team follows SOPs (Standard Operating Procedures) and regulatory guidelines such as ICH GCP
- Serve as the key contact for the contracted CRO, and ensure accurate and timely information flow within the Chimerix cross-functional team
- Serve as primary reviewer for project level study plans and amendments (e.g., project plan, monitoring plan, risk plan) and provide/coordinate input on all other functional group plans (e.g., data management plan, medical monitoring plan, safety management plan)
- Review regulatory submission packages (e.g., CTAs) from an operational perspective and provide feedback when appropriate
- Oversee finance requirements for clinical trials such as accruals and forecasting
- Experience in contributing to or creating clinical operations SOPs
- International/multi-national trial experience
- Review vendor payments/invoices to ensure they are in-line with agreed upon contracts
- Experience reviewing site essential documents and IP release packets
- Respond to investigative site questions and Clinical Research Organization (CRO) regarding protocol issues and implementation
- Technical experience in reviewing labs manuals for use in clinical trials
We are currently seeking a CONTRACT Clinical Supply Chain Manager in our Durham, NC headquarters. The selected individual will provide oversight of clinical and non-clinical supplies, track inventory levels/manage expiry dates, and liase with Clinical Project teams.
- Contract oversight for CMC related vendors.
- Review and negotiate vendor contracts/proposals, initiate POs, and process all invoices for payment.
- Assisting in the scheduling and maintaining of all vendor activities/campaigns related to manufacturing, packaging, labeling, and distribution by working closely with vendor Business Development & Project Managers.
- Maintain communication with vendors as primary contact; escalating project status and any issues with supervisor as appropriate.
- Coordinate overall CTM inventory to support upcoming clinical studies.
- Coordinate and complete CMC documentation for IND submissions (i.e. Annual Reports, IND Amendments, etc.)
- File and maintain API and Finished Product batch records per the requirements of Chimerix SOPs.
- Process documentation for proper internal release of each batch of API and CTM for use in clinical trials.
- Request CTM for clinical studies and maintain related documentation according to Chimerix SOPs.
- Review and approve IVR/IWRS specifications to fulfill the design of each clinical study along with the Clinical Program Manager.
- Employ and manage the IVR/IWRS throughout the duration of the clinical study.
Chimerix is seeking a Director, Regulatory CMC to provide strategic guidance on global regulatory CMC activities. The selected individual will have significant experience in creating regulatory strategy, reviewing and approving CMC modules, and providing insight to project team in order to ensure compliance with regulatory requirements.
Roles and Responsibilities
- As a member of the project teams, provide strategic guidance on FDA and global regulatory requirements for CMC development and registration.
- Compile, review and approve CMC modules of development and marketing registration applications, amendments, and supplements for submission.
- Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
- Serve as CMC regulatory lead at internal meetings as well as at meetings with business partners and regulatory agencies for all CMC related issues.
- Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
- Collaborate with contract staff and vendors as needed to support regulatory activities.
- Provide creative and innovative solutions while being an advocate for compliance.