Job Title: Apheresis / Infusion Program Manager
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 Apheresis / Infusion Program Managerwill be responsible for the overall design and management of the program. This newly created role will report to Senior Vice President of Technical Operations.
This position is responsible for day-to-day operations related to managing the apheresis and infusion centers participating in Talaris clinical cell therapy trials. The primary responsibilities of this role focus on training, oversight, and technical support for our external apheresis collection and infusion centers. Secondary responsibilities include assistance with shipping logistics and patient coordination associated with each clinical trial.
Responsibilities of Apheresis / Infusion Program Manager
- Provide education for healthcare professionals related to apheresis and infusion processes, product receipt and handling, product administration, and process questions.
- Establish and maintain all programs and infrastructure required to develop, onboard and manage clinical and commercial apheresis collection and infusion sites. This includes protocols, handbooks, training program and materials, qualification program and materials, contracts, business development materials, deviation/issue resolution
- Collaborate with internal business partners (Clinical Operations and Patient Operations) to develop and finalize apheresis site launch plans (locations and timelines) to support clinical trials and commercial products.
- Develop and execute detailed work plans for on-boarding new apheresis and infusion site accounts in alignment with the clinical/commercial site launch plan. Report status to internal stakeholders. Create risk mitigation plans for sites where timelines are at risk and report to the team.
Apheresis Technical Support
- Provide technical expertise and nursing guidance for our network of Apheresis Collection Sites (ACS).
- Participate in the qualification process of new Apheresis Collection Sites by acting as the technical/nursing lead during on-boarding
- Provide on-site monitoring support to ensure consistency and compliance to Talaris’ process requirements.
- Identify and manage technical issues by working closely with internal team members to monitor ACS site performance, maintain strong relations with ACS staff, and successfully resolve issues or concerns between the ACS and infusion sites.
- Provide real-time collection support of the ACS network.
- Work collaboratively with internal team members to develop and manage apheresis and infusion-related performance metrics and vendor scorecards. Responsible for reporting metrics to internal and external stakeholders, and for ensuring that appropriate actions and/or decisions are implemented as a result of the performance metrics.
- Establish and maintain collection site relationships throughout the vendor lifecycle, from selection, on-boarding, contracting, contract management, ongoing vendor / site evaluation, issues resolution/escalation and vendor retirement. Relationships are developed at all levels including Medical Directors/Physicians, Nurse Managers, Collection / Infusion Nurses, business development and legal representatives.
- Develop, manage, and participate in collection center audits
- RN and BSN or RN required.
- Advanced degree in a health services field (e.g., MSN, MPH, MHA) and advanced training in clinical practice (e.g., OCN, ARNP, CCRI or CRNI) preferred.
- Five or more years of related experience in a commercial pharmaceutical environment or equivalent setting desired.
- At least two years of experience with leukapheresis, therapeutic apheresis or peripheral blood stem cell collections preferred.
- Ability to work effectively in a fast-paced environment and consistently meet deadlines
- Strong work ethic, methodical approach to new challenges
- Team-oriented interpersonal skills are essential
- Flexibility and dedication: Position will require “off-standard hours” and “on-call” hours related to specific clinical trials, including some nighttime hours during manufacturing; may require overtime. Travel to clinical sites will be required.
Apply: Please submit resume or CV and cover letter to hiring@Talaristx.com
Talaris is an equal opportunity employer and prohibits unlawful discrimination.