Senior/Clinical Project Manager

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.

Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

Summary of the Position :

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 offers a base salary, annual bonus, equity grants, 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 is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.

Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.

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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)