Imvax™ is a clinical-stage biotechnology company focused on the development of novel patient-specific vaccines and immunotherapy strategies for the treatment of malignant gliomas and other cancers with unmet medical needs. It was launched as a stand-alone company in December 2015, to accelerate research and development of its vaccine to treat glioblastoma and opened a state-of-the-art headquarters and research facility in Philadelphia in early 2020. The company is accelerating the development of IGV-001 and expects to initiate a Phase II trial in late 2020.
IGV-001 is a first-in-class autologous vaccine in development for the treatment of newly diagnosed glioblastoma multiforme (GBM). Based on early clinical research, one treatment with IGV-001 has the potential to trigger a multi-pronged immune response, including a short-term innate immune response followed by longer-term powerful adaptive immune activity that is selectively directed at tumor cells. IGV-001 has been granted orphan drug designation by the FDA.
The Clinical Operations CRA is responsible for ensuring the successful opening and operation of clinical trial sites across the US through collaboration both within the Company and a variety of vendors . In this role it will be critical to execute on established timelines (within budget) and to contribute to vendor selection for clinical studies. The Clinical Operations CRA provides sponsor oversight of CRO and vendors and will regularly interface and partner with key business stakeholders and team members across several functions, including CMC, Regulatory, R&D, Data Management and Statistics as well as external physicians, clinicians, research staff. At this early phase in our trial development we expect this role to be a blend of remote and office based work in our headquarters and new state of the art laboratory facility located in Philadelphia Pennsylvania.
- Responsible for managing CRO and vendors
- Responsible for the maintenance of the in house electronic Trial Master Files (TMF).
- Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with Imvax SOPs, GCP and ICH Guidelines
- Responsible for CRO review of regulatory documentation to support study start up activities, including ensuring all site supplies are available on site for site initiation visits
- Acts as primary liaison for assigned study sites, CROs and Vendors to convey project information, answer questions and resolve issues in accordance with the CTM escalation pathway
- Responsible for training and oversight monitoring of the CRO of clinical trial sites
- Travel to sites to train cellular lab facilities to coordinate with study sites to prepare point of care immunotherapy drug product (point of care = drug is manufactured on site with patient’s own tumor cells and antisense RNA)
- Attends Investigator Meetings and study-specific training for assigned trials
- Ensures all regulatory documents and study supplies are maintained during the lifecycle of assigned clinical trials in collaboration with the CRO
- Monitors subject recruitment and treatment status remotely through CTMS and EDC systems and manages CRO to update detailed tracking sheets daily
- Works with CRO on various study related tracking sheets to determine and report status of clinical trial documents (distribution, status, retrieval of such documents as protocol, IB, etc.) and responsible for the follow up to collect outstanding documents
- Understanding of assigned clinical trial protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned trials
- Participate in the study budget process and invoice tracking for 3rd party CROs, Vendors, Consultants and Clinical Sites
- In partnership with the Clinical Ops Lead, will prepare meeting agenda, minutes and action items
- Taking the initiative and identifying new approaches to resolve problems and mitigate risks
- Serves as mentor for junior CRAs and those new to the company and/or trial
- All other duties as assigned/required to meet the clinical trial requirements
Professional Experience and Qualifications
- BS/BA degree is required preferably in a Life Science discipline; Master’s degree preferred.
- A minimum of 5-8 years of direct expertise with clinical site management, CRO/Vendor management and logistical execution of clinical trials is required; cell therapy and oncology trial experience along with recent start-up environment experience strongly desired.
- Solid working knowledge of ICH GCP as it relates to clinical trial management.
- Understanding of clinical trials, drug development, Phase I through Phase III (cell therapy experience strongly desired)
- Ability to travel nationally 40-50%
- Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
- Strong Microsoft Office skills, especially in Word, Excel and PowerPoint.
- Has a collaborative style with internal company leadership, external development partners and investigators/medical professionals.
- Demonstrates a passion for helping improve the quality of life and reduce morbidity and mortality for adult patients with malignant tumors.
- Team player, works well in a team environment both as a leader and a key contributor
- Analytical Thinking: Ability to comprehend a situation by breaking it down into its components and identifying key or underlying complex issues. Systematically organizes and compares the various aspects of a problem or situation and determines cause-and-effect relationships and able to define and summarize actionable recommendations.
- Patient Focused: Dedication to enabling translation of preclinical research into impactful human therapies
- Communication skills: Ability to understand the audience needs across all forms of communication (phone, in-person, email and documents) and to convey the information concisely and in an engaging manner.
- Self-motivated: To initiate independent and collaborative work assignment(s); raises hand to assist coworkers proactively.
- Flexibility: Able to reprioritize as competing interests arise and to operate successfully in an environment with a developing structure.
- Accountability: Strong commitment to ensure quality and timely deliverables while maintaining and building relationships with coworkers, mangers, vendors and clients.
At Imvax we strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Imvax has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development. With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package including (but not limited to) medical, dental and 401k with a generous company match. Imvax is an equal opportunity employer dedicated to the selection of the best qualified individuals for the job regardless of race, age, color, religion, sex, national origin, ancestry, marital status, sexual preference, disability or any other status protected by law.