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, Roche, 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.
Provide strategic contribution and support for Inovio Pharmaceuticals while collaborating with respective Commercial, Biostatistics, Epidemiology, and Clinical colleagues in the development and implementation of components of an External Engagement, Data Generation and Lifecycle program for multiple assets.
Essential job functions and duties may include the following:
Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.
Ensure development of and adherence to safety review. Performs and documents regular review of individual subject safety data, and performs review of cumulative safety data.
Monitor study safety issues and provide input to serious adverse events (SAEs) reports
Participate in Safety Review to evaluate medical benefits/risks to support targeted clinical indications
Review literature as needed to respond to safety questions
Communicate safety information to sites across the study and provides responses to questions on safety.
Contribute to and work towards full responsibility for clinical protocol design to meet stated objectives and assure that clinical trial objectives fit with the clinical program strategy
Provide medical input during development and updates to the clinical development plan
Ensure that documents (protocol, Informed Consent Document [ICD], etc) meet regulatory requirements and company policy for review and approval by IRB/IECs
Provide medical input into country feasibility assessments for clinical trials.
Provide clinical input to protocol/study team for monitoring guidelines, statistical analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed.
Develop and maintain peer to peer relationships with healthcare professionals at clinical trial sites.
Contribute to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied.
Work with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., during study execution.
Conduct medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and development of clinical study reports. The clinician medical monitor is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and seeks to ensure patient safety.
The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds.
In coordination with cross functional leadership, participate in the engagement planning with the external community including KOLs and other key external stakeholders, to ensure that medical strategies reflect customer needs.
Participate in the development and implementation of customer insight planning (including Advisory Boards) to gather expert guidance to advise medical planning. Coordinate US regional input into global Advisory Board planning, support implementation and presentations (as needed).
Develop US specific strategic plans associated with Investigator-Initiated Research, Collaborative studies and any Independent Grants programs.
Develop and execute Phase I through IV clinical trial strategies and concepts to support regional medical business needs.
In collaboration with Outcomes and Evidence partners, develop real world data generation and dissemination plan and support execution
Post graduate M.D. or D.O. degree or foreign equivalent with completion of specialty training. Subspecialty training is desired with preference for women’s health (gynecology)
Demonstrated clinical competence based on multiple years of clinical experience beyond specialty training
Strong communication skills: ability to facilitate open discussion and debate among key stakeholders and build internal and external relationships through self-awareness, partnering, anticipating needs, and fulfilling expectations
Ability to work with multiple clients and stakeholders
Very strong strategic skills including creativity and effectiveness in proactively identifying and addressing challenges
Well-organized with the ability to be flexible, prioritize multiple demands, and effectively influence without authority in a matrix organization
Ability to perform complex data analysis and translate into actionable insights
Travel up to 25%