Clinical Scientist 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 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 summary
The clinical scientist is responsible for overall clinical study conduct of Inovio clinical trials including verification of source documentation versus Case Report Forms to ensure accurate and complete data and compliance with protocol(s) and Federal regulations, ICH, & GCPs, and local requirements. Duties may also include oversight of clinical trial operations as performed by a CRO or other external consultants.
Essential job functions and duties
- Must meet all requirements for Associate Clinical Scientist position and have demonstrated proficiency in all areas
- Fulfill Clinical Project Lead (CPL) responsibilities, as assigned
- Author or prepare clinical protocols, informed consent forms, clinical study reports, regulatory documents (e.g., IND, BLA, etc.), and other clinical documents by coordinating input from internal team members and external sources.
- Develop and manage study timelines and budgets in collaboration with cross functional teams; mitigate challenges that occur
- Complete assigned tasks in accordance with SOPs and guidelines, Good Clinical Practice (GCP), International Council on Harmonisation (ICH) guidelines and regulatory requirements for clinical trial management
- Lead multidisciplinary Project Teams to ensure trial deliverables are met according to timelines, budget, quality standards and operational best practices
- Independently manage all components of clinical studies to strategically implement clinical development program(s)
- Collaborate with strategic sourcing on the development of RFPs and participate in selection of CROs/vendors
- Establish strong partnerships with external investigators and collaborators and communicate study-related information to investigators and study staff
- Oversee and track recruitment and retention of study subjects
- Proactively identify potential operational challenges (e.g., internally/CRO/vendor/investigator) and provide resolution plans and implement solutions to achieve project goals
- Develop tools and processes that increase efficiencies of the project
- Plan and participate in conduct of Investigator Meetings
- Provide protocol and trial specific training at Investigator Meetings and Site Initiation Visits
- Assist in determining the activities to support a project's priorities within functional area
- Train CROs, vendors, investigators, and study coordinators on study requirements, as needed
- Ensure ongoing activities (e.g., sponsor updates, drug shipments, publications, milestone payments, etc.) for efficient study management and clinical trial execution
- Manage and oversee vendors for clinical studies
- Initiate, author, and/or contribute to SOP development, implementation and training
- Contribute to the development of abstracts, presentations and manuscripts
- Coordinate the review of data listings and preparation of interim/final clinical study reports
- Provide knowledge and expertise on country specific regulations, site experience, and suitability for development studies
- Recruit, hire, manage, mentor, and develop junior staff members (e.g., Associate Clinical Scientist, CTA and/or Clinical Intern), as assigned
- Serve as the key operational contact with external investigators and internal stakeholders
- Provide progress updates and summaries to supervisor and/or management
- Participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
- Serve as a resource for others within the company for clinical trials management expertise
- Examine functional issues from and organizational perspective
- Support inspection readiness and audits as required
- Participate in vendor and site audits as needed
- Other tasks may be assigned based on skill sets and business need
Minimum requirements
- At least 3+ years of experience and a BS or BA in a relevant scientific discipline
- Therapeutic Area(s) experience preferred: Infectious Disease, Vaccines, Oncology, or Women's Health.
- Experience with vaccines highly preferred
- Regulatory Affairs experience a plus
- Medical device experience a plus
- MS Office Suite proficiency (Word, Outlook)
- Excellent oral and written communication skills, attention to detail and ability to interact effectively with management and prioritize diverse projects for multiple disciplines
- Excellent teamwork, communication, decision-making and organizational skills
- Thorough understanding of FDA regulations, GCP/ICH guidelines, and ISO requirements is required.
- Up to 20%, primarily domestic
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..