Inovio Hiring For Vice President, Clinical Science and Operations, Infectious Diseases at Plymouth Meeting, PA  Full Time

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, Walter Reed Army Institute of Research, and The Wistar Institute. For more information, visit www.inovio.com.

Job summary

The Vice President of Clinical Science and Operations, Infectious Diseases, oversees and directs the strategy, planning and execution of all Infectious Disease clinical trials for the Company and will oversee clinical device related activities. The selected individual ensures that all clinical science and operation activities are executed in the most cost and time effective way, while assuring quality, GCP and ICH compliance and adherence to all applicable regulations. Additionally, he/she oversees the design and feasibility assessment of clinical protocols. The VP will be accountable for timelines and budget, including best practice vendor and consultant management in achieving deliverables. Further he/she leads, develops and coaches a team of highly effective clinical science and operations professionals.

Summary of essential job functions

• Accountable for the successful execution of the Company’s Infectious Disease clinical trials ensuring they are conducted within timelines, budget, and regulatory/corporate quality standards, establishing, and managing against a set of metrics for quality, timelines, and efficiency.
• Oversee departmental processes for device related clinical activities including participation in next generation device development, user manual review, translations, device complaints and others as needed.
• Collaborate with various functional areas to ensure adherence to device regulations and guidance for US and ExUS.
• Direct project planning, budget, forecasting and resource management for clinical programs/studies as well as departmental contract negotiations.
• Provide strategic input into protocol design and development of critical study documents, such as protocols and related documents, with increased focus on operational feasibility.
• Develop overall compliance strategy to ensure adherence to applicable regulations by the clinical sites, CROs and other 3^rd party vendors.
• Oversee proposals and selection of CROs and other vendors for the conduct and management of clinical trials
• Ensure compliance with GCP and other applicable regulatory guidelines, including SOP development, implementation, and monitoring.
• Develop risk management and contingency plans for clinical trials; recommend and implement innovative process ideas to impact clinical trials management and timelines.
• Accountable for resource management of clinical operations staff, including resource allocation, hiring, and performance management for managed studies.
• Effectively lead the planning and allocation of resources to clinical research projects by identifying staffing needs and assigning staff to clinical studies that are appropriate to their experience and training.
• Work with all clinical staff to prospectively and routinely anticipate problems and implement measures to prevent them, develop solutions to more complex problems.
• Maintain collaborative relationships with key opinion leaders, investigators, and other study personnel as necessary, to ensure appropriate trial design and objectives, and compliance with protocol and overall clinical objectives.
• Partners with other department heads to maintain strong positive collaborations and ensure priority setting, budgeting and resource deployment
• Travel to vendors, scientific meetings, and investigational sites to effectively build relationships and manage ongoing and future clinical trial activities.
• Act as a cross functional liaison to ensure clinical trial plans align with program development/commercial.
• Represent clinical operations plans and status to external partners and alliances, both internally and externally.
• Interacts with FDA and other global regulatory agencies as needed.
• Contributes to or leads multidisciplinary task forces to support continuous improvement (i.e. SOP harmonization, inspection readiness).
• Travel up to 25%.

Minimum requirements

• Master’s degree in life science/healthcare required
• At least 15 years of clinical research experience with a minimum of 10 years staff management experience
• Extensive experience leading early and late phase global clinical trials
• Experience leading teams running global clinical trials.
• Vaccine experience required
• Medical device experience required
• Thorough knowledge of all applicable regulations, including FDA/EMA, ICH, GCP and ISO guidelines.
• Excellent oral and written communication skills, attention to detail and ability to interact effectively with management and prioritize diverse projects for multiple disciplines.
• Experience and strong track record of managing multiple projects and priorities.
• Experience interacting with and presenting to senior management teams, internal and external (CRO or Partner)
• Excellent leadership, management, collaboration, communication and decision making skills.
• Effective process and project management skills.
• Independent, innovative, and creative thinker.
• Proven ability to positively impact company culture and demonstrate flexibility in fast paced environment.

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 job. 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.

To comply with government Equal Employment Opportunity / Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated.