Associate Director/Director, Global Clinical Compliance


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Gaithersburg, MD

Job Description

As posted by the hiring company

Job Overview:

**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.**

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.

We are seeking a motivated and experienced individual to serve as Associate Director/Director, Global Clinical Compliance in support of a growing number of clinical stage vaccine development programs. The focus for this position is to lead the development, implementation, and training for procedures owned by various functions in the Novavax Medical Office (NMO) (which include Clinical Operations, Medical Writing, Biostatistics, Medical Affairs, and Clinical Development). This position will collaborate across the groups within the Novavax Medical Office and liaise with the compliance functions within Global Vaccine Safety (GVS) and Clinical Immunology.  The position will also collaborate closely with the Quality organization. This position will report to Executive Director, Global Clinical Compliance.

Responsibilities include but are not limited to:

  • Leads, authors and/or oversees the development of new/revised procedures owned by the Clinical Operations, Medical Writing, Biostatistics, Medical Affairs, and Clinical Development departments.
  • Serves as a liaison with GVS and Clinical Immunology compliance functions on procedures and training, as needed.
  • Accountable to ensure procedures in NMO cover regulatory requirements and works to close gaps, as applicable.
  • Drives consistency across the suite of procedures required for the NMO and ensures outcomes comply with regulatory requirements.
  • Defines strategy and leads in a matrix environment to guide authors through the procedural development/revision process, as applicable. May also serve as author in collaboration with Subject Matter Experts.
  • Leads the SOP Review Committee. Defines strategy, reviews and analyzes draft procedures to ensure compliance with regulatory requirements. Provides project management oversight for the lifecycle of procedures.
  • Serves as a key contact within NMO with regard to procedures and training management.
  • Responsible for continuous improvement of NMO procedures and training.
  • Recommends training requirements within the NMO functions and manages/maintains curricula related to NMO functions by collaborating with NMO Leadership to maintain training assignments for NMO staff.
  • Provides inspection readiness support for NMO. Coordinates with Quality on inspection readiness initiatives, and provides inspectional support to NMO during inspection conduct.
  • Serves as a key collaborator across NMO functions and QA with regard to NMO procedures and training. Provides support in preparation for and during regulatory inspections.
  • Links procedures and training to overall leadership strategy to ensure procedures reflect current business processes.
  • Provides compliance support to study teams by providing compliance guidance, supporting root cause analysis and CAPA development.
  • Provides compliance support to functions in the NMO globally and provides compliance updates to Executive Leadership.

Minimum Requirements:

  • BS/BA degree with minimum of 10 years of experience in pharmaceutical industry or a Master’s degree with 7+ years of experience.
  • Advanced knowledge of ICH-GCP guidelines relating to Clinical Trials and applicable drug and biologic development regulations.
  • Overseen or participated in the implementation of procedures and training.
  • Solid understanding of Clinical Operations, Medical Writing, Biostatistics, Medical Affairs and Clinical Development activities.
  • Advanced knowledge of process mapping with experience developing process flow charts.
  • Excellent project management skills (PMP certification a plus).
  • Excellent written and verbal communication skills.
  • Strong interpersonal skills with a focus on customer service.
  • Innovative, self-starter, highly organized, outcome oriented, problem solving, able to think outside of the box. 
  • Comfortable in a fast-paced small company environment with minimal direction; change agile and able to adjust workload and priorities.

Additional Desirable Skills:

  • Experience with electronic systems for document and/or training management.
  • Proficiency with standard office software (Microsoft Office).
  • Skilled with MS Visio and MS Excel.
  • Excellent verbal and written communication skills in English.

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.