Senior Director, Clinical Development, MD
- Expired: October 15, 2021. Applications are no longer accepted.
About INOVIOINOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and human papilloma virus (HPV) diseases. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)/Department of Defense (DOD), GeneOne Life Science/VGXI, HIV Vaccines Trial Network, International Vaccine Institute (IVI), Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health...
National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Roche/Genentech, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. For more information, visit www.inovio.com.Job summaryThe primary role of the Senior Director, Clinical Development is to provide clinical and medical expertise to advance INOVIOs pre-cancer (HPV) and oncology pipeline. S/he is a key member of the senior staff and contributes to the clinical strategy and execution of clinical pre-cancer and oncology programs.
The Senior Director, Clinical Development partners with the Senior Vice President, Clinical Development to provide medical monitoring, strategic input, and overall clinical trial leadership and support, while collaborating with colleagues in Clinical, R&D, Regulatory, Commercial, Biostatistics, and Epidemiology as well external partners including contract research organizations (CROs), principal investigators, clinical site personnel, key opinion leaders and funding agencies.Success in this role requires self-motivation, creativity, integrative thinking, and a strong work ethic. The candidate is expected to thrive in a dynamic, changing environment of biotechnology. This role may also be upgraded to Vice President, Clinical Development, if commensurate with experience.Essential job functions and dutiesThe Senior Director, Clinical Development will lead the medical and clinical input to the cross-functional team and is accountable for the scientific content of all study design and data interpretation activities and deliverables, including clinical content of protocols and clinical study reports and publications.
In addition, s/he will participate in program and study planning, and governance interactions such as investment decisions for planned and ongoing studies in HPV and oncology.Accountable for safety across the study: Provide leadership for medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site, and patient level. Lead development of and adherence to safety review. Perform and document regular review of individual subject safety data and 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 provide responses to questions on safety.Develop protocol design and strategy: Provide medical leadership during development and updates to the clinical development plan. Design clinical studies to meet the stated objectives. Ensure clinical trial objectives fit with the clinical program strategy.
Review and ensure that documents (protocol, Informed Consent Document [I
AddressPlymouth Meeting, PA
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