Senior Clinical Project Manager

Novavax Gaithersburg , MD 20877

Posted 2 months ago

Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, and achieved positive Phase 1 clinical trial results. NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

The Clinical Project Manager (CPM) is a study team leader responsible for the clinical operation operational delivery of one or more clinical studies through reporting, including inspection readiness and risk management, and in alignment with the program strategies. The CPM is an expert on the operational strategy of clinical trials, lead CRO and vendor oversight activities, and responsible for developing the study timelines and management of the study budget. The CPM leads and manage the internal cross functional study team and provides regular status reports to internal key stakeholders, including program team and senior management.

Responsibilities include but not limited to:

  • Clinical operation project leader for assigned clinical studies including selection and oversight of full service CROs. Oversees on time study deliverables of key milestones. Establishes vendor management plans and manages CROs and study-related vendors accordingly (inclusive of quality plan).

  • Manage study financials including vendor work order development and approval, invoice review, monitoring spend, facilitate regular forecasting communication between Finance departments. Manages vendor work order changes.

  • Active participant in CRO lead meetings, including regular CRO study team meetings and protocol training (e.g., Investigator Meeting, CRA training), responsible to review key CRO study operational plans (e.g. risk management plan, monitoring plan, communication plan, etc.); proactively provides input to operational strategy, including country and site feasibility.

  • Tracks study progress and proactively escalates project related issues, including related to time, budget, and quality, to the key internal stakeholders to ensure timely resolution of issues.

  • Leader of internal cross functional study team; manages, facilitates and documents meetings (e.g. action log) and facilitates effective decision making, cross functional connectivity, and communications are effective and efficient. Partners with Manufacturing Operations to create clinical trial material labeling and packaging plans, and Clinical Immunology to ensure quality and timely delivery of samples for testing.

  • Ensures comprehensive operational input to protocol design.

  • Lead clinical operations sub-team(s) where appropriate, e.g. for large programs with multiple studies, in accordance with the organizational expectations.

  • Contributes to knowledge management within Clinical Development (incl. lessons learned from previous studies are considered in new study design and implementation).

  • Provides Program Team and Senior Management with regular study updates/status reports on study execution. Acts as a liaison between departments within Novavax for project-related matters.

Minimum Requirements:

  • BS/BA degree or equivalent (background in life sciences preferred). Advanced degree is preferred.

  • 6+ years of industry experience (biotech/pharma) with at least 2 years of clinical project management experience (at least 5 years for senior clinical project management experience).

  • Global clinical trial conduct and clinical operations experience, from start-up to database-lock. A thorough understanding of the processes associated with project and study management.

  • Strong understanding of ICH, Good Clinical Practices (GCPs), clinical, and regulatory operations.

  • Experience in management of vendors and CRO's and managing project to budget.

  • Excellent communication skills and management skills with attention to detail.

  • Strong understanding of ICH, GCP and relevant regulatory requirements.

  • Proficiency with MS Project, Microsoft Outlook, Excel, Word, PowerPoint.

  • Ability travel globally up to 10% of time.

  • Prior experience managing outsourced global vaccine studies preferred.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity Employer/Veterans/Disabled

Novavax, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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