Location: Louisville, KY
Talaris Therapeutics, Inc. (“Talaris”) is developing a breakthrough, one-time cell therapy to enable patients who receive a living donor kidney transplant to no longer require lifelong immunosuppression, without rejecting their donated organ. Achieving durable, drug-free immune tolerance to a donated organ has been referred to as a “Holy Grail” of organ transplant. In a ground-breaking, phase 2 study conducted between 2008 – 2016, our lead therapy, FCR001, enabled 70% of patients to be weaned off all immunosuppression within 12 months of their kidney transplant. No tolerized patient has had to resume immunosuppression. We have followed these patients for an average of almost five years since their transplant, and the longest for over ten years. Our single-dose cell therapy has also shown the potential to induce durable remission of certain types of severe auto-immune diseases, and to benefit other solid organ transplant patients. Talaris recently closed a $100M private financing from leading life sciences investors. We will be initiating a Phase 3 pivotal trial of our therapy in living donor kidney transplant patients later in 2019. We will also be initiating two Phase 2 trials of our therapy in additional indications in 2020. Our cell processing facility and most of our operations are based in Louisville, KY, and we also have a corporate office in Boston, MA.
The Clinical Trials Manager (CTM) is responsible for providing oversight aiding Clinical Operations with activities related to the daily management of clinical trials. The CTM takes direction from and reports into the head of Clinical Operations.
- Management and oversight of clinical trials
- Assist with the review, collection and tracking of clinical trial documents, such as informed consent forms, protocols, IBs regulatory documents, etc.
- Ongoing filing in the TMF(s), in preparation for audits and due diligences
- With guidance and mentoring from the head of Clinical Operations, assist with the development of study specific training materials, answering routine study questions, and vendor communication
- Establish and maintain both hard copy and electronic study files on the Clinical Drive
- Attend regularly scheduled operations meetings and prepare/distribute team agendas and meeting minutes as required
- Assist the project team in communicating with the sites for various purposes, including feasibility/site identification activities, site updates, and query resolution
- Assist with clinical trial support and projects based on study needs
- Other duties as assigned commensurate with experience and workload
- Provide executive administration support on a need basis
- 5+years of experience with a pharmaceutical, bio-tech, life sciences company, or contract research organization
- Understanding and proficiency in ICH / GCP, FDA, local regulations and clinical trials research processes and systems
- Strong verbal and written communication skills with ability to communicate and work productively in a team environment
- Proficient computer skills i.e. Microsoft Project, Word, PowerPoint, and Excel
- Excellent organizational skills, ability to work independently and with moderate guidance
Apply: Please submit resume or CV and cover letter to hiring@Talaristx.com
Talaris is an equal opportunity employer and prohibits unlawful discrimination.