Chijioke Bennett. MD, MPH, MBA
Senior Director, Clinical Development at NOVAVAX INC- Claim this Profile
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English Native or bilingual proficiency
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Igbo Native or bilingual proficiency
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Yoruba Professional working proficiency
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Hausa Elementary proficiency
Topline Score
Bio
Dr Ijeoma Idaresit
CJ is larger than life. We were classmates in medical school and worked as part of a team for the 2006 Public Health Programs Committee of our school's medical students association. He was creative and resourceful and the life of every meeting. Dr Madugwulike is an articulate orator and ALWAYS gets the job done.
Adaobi Nwangwu, MPH
Chijioke is focused and hardworking and will be an asset wherever he works
Dr Ijeoma Idaresit
CJ is larger than life. We were classmates in medical school and worked as part of a team for the 2006 Public Health Programs Committee of our school's medical students association. He was creative and resourceful and the life of every meeting. Dr Madugwulike is an articulate orator and ALWAYS gets the job done.
Adaobi Nwangwu, MPH
Chijioke is focused and hardworking and will be an asset wherever he works
Dr Ijeoma Idaresit
CJ is larger than life. We were classmates in medical school and worked as part of a team for the 2006 Public Health Programs Committee of our school's medical students association. He was creative and resourceful and the life of every meeting. Dr Madugwulike is an articulate orator and ALWAYS gets the job done.
Adaobi Nwangwu, MPH
Chijioke is focused and hardworking and will be an asset wherever he works
Dr Ijeoma Idaresit
CJ is larger than life. We were classmates in medical school and worked as part of a team for the 2006 Public Health Programs Committee of our school's medical students association. He was creative and resourceful and the life of every meeting. Dr Madugwulike is an articulate orator and ALWAYS gets the job done.
Adaobi Nwangwu, MPH
Chijioke is focused and hardworking and will be an asset wherever he works
Credentials
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Communicating with Empathy
LinkedInJan, 2022- Nov, 2024 -
How to Speak So People Want to Listen
LinkedInJan, 2022- Nov, 2024 -
CPR BLS
American Heart Association | American Stroke AssociationDec, 2013- Nov, 2024
Experience
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Novavax
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Director, Clinical Development
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Dec 2020 - Present
• Leads the clinical development program. • Direct and provide cross-functional oversight for phases I-IV clinical trials to ensure all clinical development milestones are met. • Participates in the medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals. Coordinates and develops information for reports submitted to FDA, CDC, WHO, or other government, regulatory, or partner agencies • Lead presentations to various external stakeholders - regulators, governing/harmonization bodies, principal investigators, scientific conference attendees, advisors, and opinion leaders • Demonstrate mastery and subject matter expert level of knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including but not limited to adherence to protocols, safety reviews, assay development, training, and clinical document review • Coordinate the planning, reviewing, and editing of Clinical Study Reports • Providing input on the design of preclinical studies supporting clinical strategy • Leading the planning, reviewing, and editing of clinical trial publications • Manage key external technology partnerships
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Mallinckrodt Pharmaceuticals
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Ireland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Director, Clinical Development
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Jun 2019 - Nov 2020
• Provided multidisciplinary, scientific/medical leadership across multifunctional project teams. • Provided scientific, technological, and medical knowledge and expertise for the clinical research aspects of the project and provides clinical and therapeutic expertise, with a working knowledge of regulatory affairs, for the development of the project strategy and the clinical development plan (CDP). • Provided medical and scientific input to the core documents for the project (e.g., product strategy documents, target product profile (TPP), protocols, submission, etc). • Developed, executed and regularly maintained the project CDP and other relevant clinical documents that are consistent with the project goals. • Consulted with internal/external stakeholders and key opinion leaders to validate the scientific and medical components of the CDP. • Worked closely with the clinical operations group, and provides strategic direction to support timely and on-budget development and execution of the clinical development program. • Served as the scientific or medical representative with investigators and regulatory authorities and interacts with the Medical Science Liaison personnel. • Developed and gained approval by Senior Management for study protocol outlines and study plans created by the clinical project team. • Participated and supported the clinical study team in site selection/evaluation including site training and to provide sufficient medical/scientific knowledge for educating the study team and investigators and explain the scientific, epidemiologic background and justification of a study/project. • Played a primary role in identifying key opinion leader(s)/principle investigators for the program to ensure the adequacy of the program’s scientific basis and participates as the lead clinical representative on cross-functional project teams. • Provided medical and scientific interpretation of efficacy and safety data
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Osiris Therapeutics
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Biotechnology Research
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1 - 100 Employee
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Senior Manager, Clinical Affairs
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Mar 2017 - May 2019
• Develop clinical development protocols for Phase 2/3 clinical trials to show efficacy and safety of advanced wound care products • Develop Investigator-Initiated Studies working with Principal Investigators to design, execute and manage clinical trials to show product efficacy either against the competition or against the standard of care • Develop and deliver scientific and clinical presentations to support Osiris’ products in commercial accounts. • Attend local, regional, and national meetings to represent Osiris in front of payers. • Cultivate relationships with local, regional and national key opinion leaders. • Represent Osiris at wound care meetings and exhibitions. • Answer scientific and disease state questions for Osiris field personnel. • Encourage the development of abstracts for submission to wound care meetings. • Participate in relevant HCP/PRC advisory board meetings • Member of the Medical Advisory Board • Participate in manuscript development from gathered clinical data. • Develop and conduct relevant clinical and scientific training for internal stakeholders. • Informs on developments in the clinical and scientific market in wound care and other fields • Respond to unsolicited requests for information from HCPs • Respond to on-going Medical Affairs requests for information from providers • Provide mentorship to new MSLs
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Atlantic Research Group
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United States
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Biotechnology
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1 - 100 Employee
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Senior Clinical Research Associate
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Mar 2016 - Mar 2017
Monitor the conduct of Phase I-IV clinical trials Participate in all aspects of a clinical trial from development and planning to study closure Conduct Site Qualification, Site Initiation, Interim Monitoring, and Close Out Visits Ensure the rights and safety of clinical trial participants Ensure that clinical data is accurate, complete, and verifiable Ensure clinical trial compliance with Federal Regulations, GCP and ARG/sponsor SOPs Ensure site compliance with protocol specific study objectives Ensure that the Trial Master File mirrors on-site Investigator Regulatory Files Track SAEs and ensure that they have been reported properly Assess the safety and efficacy of investigational products, biologics and/or medical devices Account for all investigational product on site and ensure accountability records are current and accurate Work in project teams and under supervision, reporting to a project manager Act an effective liaison between sponsors, investigators and ARG
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Medicolante LLC
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Baltimore, Maryland Area
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Clinical Research Associate
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May 2013 - Feb 2016
Consultant Carried out pre-study, initiation, routine and close out visits Monitored and evaluated trial sites to ensure compliance with GCP guidelines in keeping with SOP’s Reviewed regulatory, protocol and administrative documents from sites to check for accuracy and completeness Reviewed clinical documents including informed clinical consent to check for accuracy and completeness Provided support to the study design and development Ensured timely collection of all necessary regulatory documents from trial sites Assisted with coordination and presentation at initiation and investigator meetings Provided help with preparing clinical study reports Prepared and processed SAEs reports in accordance with sponsor SOPs, ICH GCP and FDA guidelines Managed and reported on the professional conduct of the study as dictated by study design Ensured adequate and proper handling of investigational products by overseeing and monitoring product storage, disposition, accountability and documentation Reviewed trial screening logs Maintained all sensitive patient information in compliance with HIPPA and organizational privacy policy Ensured site safety and compliance with licensure requirements and reported safety concerns to the right staff
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amfAR, The Foundation for AIDS Research
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United States
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Non-profit Organizations
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1 - 100 Employee
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Allan Rosenfield Public Policy Research Fellow
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Oct 2012 - Apr 2013
Co-authored policy papers on specific issues related to the domestic and global HIV/AIDS epidemic. Worked with USG funded programs such as USAID that funded the work of the policy office targeting a reduction of HIV incidence in most at risk population groups Contributed to the work of the public policy office by collaborating on writing and research projects, organizing meetings and conferences, and attending congressional, and NGO briefings. Co-led the research on the policy and advocacy options on how to curb the HIV epidemic among black MSM in the US Co-led the research and drive to include a HIV specific health indicator in the post-2015 Millennium Development Goals Performed extensive literature reviews Wrote Op-eds on topics of HIV policy and governance especially focusing on the global epidemic Ensured that all materials concerning research were up to date and meticulously updated Collected data and reviewed all policy documents for completeness and accuracy
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Advising Matters LLC
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Baltimore, Maryland Area
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Research Consultant
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Jun 2012 - Oct 2012
Directed the program execution of two Centers for Disease Control funded projects: taking lead in supervisory, monitoring and capacity building roles for the investigators, and program staff Created and field tested a data tracking tool to help program staff monitor the relapse patterns of their clients in the SAMSHA Evaluated field protocol and educated program staff on proper protocol Prepared and maintained files on successful monitoring visits and audits Maintained source documents and reviewed charts and tables to ensure completeness, accuracy and compliance with CDC pre-determined protocol Monitored the distribution, use and storage of program items using a batch number system
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The Johns Hopkins University
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United States
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Higher Education
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700 & Above Employee
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Student and President: JB Grant Global Health Society
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Jun 2011 - May 2012
Served as the first African to lead this body, comprised of an alumni network numbering about 30,000 at the Johns Hopkins Bloomberg School of Public Health. As the head of the executive team made up of 21 officers from over 10 different countries, I provided leadership and coaching that helped position the team to be effective and efficient in carrying out over 80 events working with global health centers and personalities across the world to plan and host seminars, community volunteering, poster presentations, lectures, discussions, symposia, health weeks, touching on topical issues of global health importance. Coordinate effective and informative events in the Hopkins school of public health to educate the school community on latest happenings in the world of global health Deliver events concerned with the HIV epidemic in homosexuals of the African continent coupled to the criminalization of the act to raise awareness and improve the quality of discussions around the topic Organize events concerned with human trafficking in south east Asia and the socio-economic impact of the practice World pneumonia and malaria day activities including discussion panels, seminars, poster presentations and film shows
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Nigerian Ministry of Defence
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Retail Office Equipment
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700 & Above Employee
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Research Coordinator
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Mar 2010 - Jan 2011
Performed pre-project, initiation and close-out visits Developed a proposal for presentation to program sponsors and supervisory staff Developed training manual and other project materials for use by project staff Provided technical assistance in project planning, implementation and evaluation Responsible for monitoring and supervision implementation process to ensure alignment with organizational policies, procedures and ICH GCP guidelines Collected, maintained and presented clinical and administrative data to project sponsors Managed project staff concerns and assisted with the adaptation of the field guide to the appropriate personnel Contributed to project and process improvements
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Research Coordinator
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Mar 2010 - Dec 2010
Developed the project plan and led the project implementation and evaluation Responsible for site management, coordination and monitoring project implementation to ensure alignment with organizational policies and procedures Independently collected informed consent as stipulated by GCP guidelines and sponsor SOP Appraised the data and developed presentation packets that were presented to the sponsors in line with the SOP Effectively coordinated project logistics not limited to patient transportation, storage of pharmaceuticals, equipment, supplies and finance related issues Maintained all clinical and administrative documentation Assisted with preparation of grants and contract documents for submission to the appropriate bodies Created a system for collecting, documenting, verifying, analyzing and interpreting project data Maintained source documents and reviewed charts to ensure completeness, accuracy and compliance with established protocols Answered telephone calls and addressed concerns and questions from patients Screened patients for eligibilities & registered patients accordingly
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University College Hospital
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Ibadan, Nigeria
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Medical Intern
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Feb 2009 - Jan 2010
Provided primary patient consultation services and lab follow up for both the out and in patients under the guidance of supervising attending physicians Diagnosed and managed adult and pediatric medical conditions with clerkships, physical exams, lab works, treatment protocols and follow up in clinic, ER and ICU settings Performed diagnostic and therapeutic procedures including but not limited to phlebotomy, catheterization, medical, surgical, obstetric and gynecological procedures Completed postgraduate medical internship with clinical rotations in Internal Medicine, Pediatrics, Obstetrics and Gynecology, General, Orthopedic and Cardiothoracic Surgery
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Education
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2011 - 2012
The Johns Hopkins University
MPH, Public Health -
2014 - 2015
Kaplan University
Master of Business Administration (M.B.A.), Business Administration and Management, General -
1999 - 2008
University of Nigeria
MB,BS, Medical Sciences -
2005 - 2006
Redhill Hospital East Surrey
Interventional Radiology Rotations -
2005 - 2006
University of London
Clinical Rotations, Obstetrics and Gynecology, Otorhinolaryngology
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