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Clinical Oversight Lead

Company Profile

Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. The company is advancing a growing clinical and preclinical stage product pipeline. Partners and collaborators include MedImmune, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.

Job summary

This may be a home or office based role working with Clinical Project Leads on priorities such as site level issue investigation, resolution, risk mitigation, CAPA implementation, and inspection preparedness.  The role will involve a significant amount of sponsor oversight activities including on-site assessment of CRAs and centralized review of study and site metrics.  This candidate will function at a high level, on quality related issues, across multiple projects, indications and therapeutic areas.

Essential job functions and duties

Work with Clinical Project Leads to investigate and resolve issues at clinical sites or with CROs, initiating and facilitating CAPA plans as required
Remotely review all study related data against study metrics for early identification of potential issues
Detection of safety signals, consistency of data entry, delayed data entry, excessive deviations, etc. based on centralized review of study data
Assist Inovio and clinical sites in preparation for inspections
On-site CRA assessments
Some domestic and international travel required (estimated at approx. 80%)

Minimum requirements

Bachelor’s degree in life science or healthcare, or nursing qualification and experience
Oncology and/or Infectious Disease experience (Immuno-oncology or Vaccine experience preferred)
5+ years of monitoring sites in relevant disease indications

Essential requirements

Site management skills, including issue resolution and negotiation
Successful experience implementing and monitoring CAPA plans
Prior experience working with sites to prepare for Regulatory Authority inspections
Experience with multiple EDC platforms, including remote monitoring
Ability to multi-task and interact at multiple levels in a growing, fast paced organization
Thorough knowledge of ICH-GCP and FDA/EMA regulations (ISO guidelines and device experience a plus)
Results driven, with excellent communication skills, and ability to work independently
Prior experience monitoring, extrapolating and interpreting data from a Risk Based Management software tool to improve quality project oversight (preferred)

 

Disclaimer

Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

A current US work authorization is required.  The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. 

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