Director, Clinical Operations, Emerging Infectious Diseases at Inovio in Plymouth Meeting, Pennsylvania

Job Description:

About INOVIO
INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. 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 an efficacious, 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), 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, Thermo Fisher Scientific, University of Pennsylvania, VGXI, Walter Reed Army Institute of Research, and The Wistar Institute. For more information, visit www.inovio.com.
Job summary
The Director of Clinical Operations Emerging Infectious Diseases oversees and directs the execution and oversight of CEPI clinical trials under the direction of the functional area head. This individual will be responsible for strategy and implementation of the clinical development plan for the CEPI program in collaboration with the Medical Monitor and the Director Clinical Development, Emerging Infectious Diseases and Global Health Programs. S/He ensures that all clinical operation activities are executed in the most cost and time effective way, while assuring quality and GCP compliance. S/He will be responsible for timelines and budget, including best practice vendor and consultant management in achieving deliverables.
Essential job functions and duties
- Works closely with the Medical Monitor (MM) and executes all aspects of medical strategies, including leading external advisory boards; provide oversight of Inovio-sponsored clinical trials and interacts with external government agencies, advisory and guidance committees, and external experts.
- Provides oversight of CEPI related projects, specifically for the scientific development of individual clinical studies in alignment with the approved clinical development plan and under highest quality standards. This may include authorship/review of clinical study protocols, CRFs, IBs, ICFs, CSRs, clinical CTD modules and other clinical documents to ensure scientific content is consistent across the development program.
- Responsible for review of clinical data and provides assessment in consultation with functional area head of study results through clinical presentations and integration of analyses into clinical documents.
- Maintain a high level of awareness of scientific developments and competitive environment in the relevant therapeutic area to provide scientific expertise in the designated clinical program(s). Supports management with implementation of departmental strategies and policies.
- Leads multidisciplinary task forces to support continuous improvement (i.e. quality circles, SOP harmonization).
Minimum requirements
- Master's degree is required. Scientific/health care field preferred, but not required.
- Minimum of 10 years in clinical development in pharmaceutical/biotech industry
- Thorough knowledge of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies globally
- Extensive experience managing complex protocols, CROs, budgets, and timelines
- Strong verbal and written communication skills including clinical authoring experience
- Ability to organize and manage multiple priorities in a fast-paced, entrepreneurial environment
- Proven track record of effective leadership with excellent organizational skills and ability to work independently
- Strong interpersonal skills to interact with investigators, vendors, and individuals at all levels of the organization
- Must be willing to travel both domestic and international
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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, gender identity and expression, religion, marital status, registered domestic partner status, age, national origin or ancestry, military or veteran status, 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.
Important notice to employment businesses/agencies
INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO..