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Job Details

AD/ Senior Clinical Project Manager

Company name
Chimerix, Inc.

Location
Durham, NC

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Chimerix

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.

Overview:

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.

Responsibilities include:

  • 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
Qualifications:

  • B.S. or M.S. and a minimum of 7 years relevant experience managing the clinical development of a compound in a pharmaceutical company or CRO.
  • At minimum 7 (but preferably 10) years' experience in an operations, management, or monitoring position in a CRO or pharmaceutical company or an equivalent combination of experience and education.
  • Previous monitoring experience strongly recommended.
  • Experience with International or Multinational studies highly preferred.
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PI101204326

Company info

Chimerix, Inc.
Website : http://www.chimerix.com

Company Profile
Chimerix is committed to the discovery, development and commercialization of novel, oral antiviral therapeutics designed to transform patient care in areas of high unmet medical need. Chimerix's proprietary lipid technology has given rise to two clinical-stage nucleotide analog lipid-conjugates, brincidofovir (CMX001) and CMX157, which have demonstrated the potential for enhanced activity and safety in convenient, orally administered dosing regimens. Chimerix's lead product candidate, brincidofovir (CMX001), is an oral nucleotide analog that has shown broad-spectrum antiviral activity against all five families of dsDNA viruses that affect humans, including cytomegalovirus (CMV), adenovirus (AdV), BK virus and herpes simplex viruses. Following positive Phase 2 results, in the third quarter of 2013 Chimerix initiated the Phase 3 SUPPRESS trial, which will support Chimerix’s initial regulatory submission for prevention of CMV infection in adult HCT recipients. Chimerix's second product candidate, CMX157, an oral nucleotide analog for the treatment of HIV infection, was licensed to Merck in July 2012.

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