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Director, Lupus Nexus (Lupus Registry & Biorepository)

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Published 23 days ago

Background

The Lupus Research Alliance (LRA) is the world’s leading non-governmental, non-profit funder of lupus research. Over the past 20 years, the LRA has invested over $200 million in lupus research in more than 500 research and clinical studies. More recently, the LRA established an affiliate organization, Lupus Therapeutics (LT), which is responsible for the coordination, conduct and management of a North American-based clinical trial consortium, the Lupus Clinical Investigators Network (LuCIN). LT through LuCIN is currently conducting 11 Phase I through III clinical trials.

This is an exciting professional opportunity to join an initiative of critical importance to the lupus community from the ground up. Be part of a team of LRA/LT staff, academic and industry experts and individuals with lupus who envision and bring to life a unique infrastructure that builds and integrates a patient registry with a linked biorepository, and a data and analytics platform. This research information exchange platform, preliminarily referred to as Lupus Nexus, will expedite scientific discovery and clinical development, will accelerate precision medicine in lupus and will ultimately transform lupus care.

Position Summary

The Lupus Nexus Director will be part of the Lupus Research Alliance’s Research Department while working closely with Lupus Therapeutics colleagues and will be instrumental in the build and management of the Lupus Nexus. In collaboration with LRA/LT senior staff and key academic and industry partners the Lupus Nexus Director is responsible for the day-to-day activities required to design, launch and implement the Lupus Nexus. He/she will perform tasks necessary to coordinate diverse activities, enable the start of the patient registry, and help identify—through open Requests for Proposals (RFPs)—the most appropriate vendors for providing the specialized components for the Lupus Nexus including the registry database, clinician/researcher/patient portals, the centralized biobank, the data management and analytics platforms, and the high-performance computing infrastructure. 

 Responsibilities

·        Manage collaborations between the LRA/LT, academic investigators, industry partners and the patient community to create the first lupus platform coalescing clinical samples/data, analytics and collaborations to accelerate lupus research and development

·        Help and coordinate the activities of the Lupus Nexus Steering Committee

·        Coordinate the activities of the individual Working Groups informing the build of the Lupus Nexus

·        Ensure accurate, timely and thorough communication between the Steering Committee and the Working Groups

·        Oversee the selection of the information technology platform components and manage its implementation and maintenance along with a LRA technology consultant

·        Manage the vendor selection process from solicitations (preparation of RFPs) to evaluations (reviews of proposals) and contracts execution

·        Work with LT staff and LuCIN investigators to coordinate the planning of a prospective, longitudinal clinical study—conducted by LuCIN—that will frame the registry component of Lupus Nexus

·        Manage the business and financial planning for the Lupus Nexus including oversight of the budget

·        Establish and oversee partnerships with diagnostic/genomic/other companies that support the goals and objectives of Lupus Nexus

·        Collaborate with LT staff to ensure timely execution of all contracts (site contracts, Material and Data Transfer Agreements, etc.) and IRB/EC approvals

·        Collaborate with LT staff to assist the clinical study operations specifically with the development/refinement of the clinical trial protocol and associated informed consent documents, preparation/execution of protocol-specific training materials and data collection tool training materials and with the conduct of site training

·        Collaborate with LT staff and oversee Lupus Nexus staff to assist in clinical study monitoring and site management/monitoring efforts.

·        Manage existing Lupus Nexus consultants and hiring/management of future Lupus Nexus staff in line with the operational requirements of the Lupus Nexus business plan

·        Oversee Lupus Nexus staff or a vendor who will coordinate with study sites on biosamples/data queries resolutions, data revision, and assist with site re-training where necessary 

·        Oversee Lupus Nexus staff who will interface with study sites to help troubleshoot eCRF technology, biosamples/data collection, and/or other related issues

·        Lead the development of the Quality management System (policies, protocols, SOPs, etc.) and oversee Lupus Nexus staff who manage these activities on a day-to-day basis

·        Coordinate with LRA marketing/communications team to ensure the appropriate outreach and visibility of the Lupus Nexus for all relevant stakeholders

·        Ensure patient engagement is at the forefront of all aspects of the Lupus Nexus

·        Contribute innovations in all areas related to the successful function and operation of Lupus Nexus

·        Identify and escalate issues appropriately to the LRA CSO and the LT ED

·        Other job functions as assigned.

 Requirements

Credentials & Qualifications:

·        BS degree or higher with educational training in a field related to the health sciences

·        8+ years of life science experience in operations or clinical trial settings

·        5+ years of experience coordinating multicenter studies that involve clinical/phenotypic data and biosamples collection ideally in a biotech or pharmaceutical setting (biorepository-related project coordination preferred)

·        Understanding of Electronic Health Record systems. Experience working with Epic and extracting data from Epic as well as knowledge of REDCap and/or related platforms preferred

·        Working knowledge of GCP/ICH/CLIA guidelines and FDA regulations

·        Proficiency in cross-functional collaboration with varied teams and stakeholders

·        Prior exposure to software development processes to create tools for sample/data management preferred

·        Certificate of training for Human Subjects Research preferred

·        Ability to travel is required.

  Skills & Competencies:

·        Demonstrated ability to think strategically when planning and managing responsibilities

·        Hands-on, self-directed, detail-oriented, organized, and conscientious

·        Must work independently and prioritize and manage multiple projects within tight timelines

·        Team player who can build excellent working relationships both internally and externally.

The LRA offers competitive salary and benefits commensurate with experience.


To apply please email a cover letter, salary requirements and a resume—in this order, in a single pdf file—to:

HR@lupusresearch.org. Incomplete applications will not be considered.

Only applicants who advance to the next stage of considerations will be contacted.

No phone calls please.

Background

The Lupus Research Alliance (LRA) is the world’s leading non-governmental, non-profit funder of lupus research. Over the past 20 years, the LRA has invested over $200 million in lupus research in more than 500 research and clinical…

Details at a Glance

  • Time Commitment
    Full Time Schedule
  • Start Date
    January 3, 2022
  • Application Deadline
    November 1, 2021
  • Education
    4-Year Degree Required
  • Professional Level
    Professional

Compensation

USD 150,000 - USD 200,000
Salary Negotiable - include salary requirements with application

Benefits

403B Retirement Savings Plan         (eligible at 6 months for 4% match)

* Health Insurance provided by United Healthcare (100% paid by LRA for employee as of

  the day of hire)  

     * Holidays (11+ per year)

     * Dental Insurance provided by MetLife (100% paid by LRA for employee)

     * Vision Care Insurance (100% paid by LRA for employee)                               

     * Bereavement Leave      

     * Jury Duty Leave                                                

     * Life Insurance (2 x salary) (100% paid by LRA for employee)                        

     * Long-Term Disability (100% paid by LRA for employee)

     * Military Leave    

     * Personal Days (3 per year)

     * Short-Term Disability (100% paid by LRA for employee)

     * Sick Leave Benefits (accrued at two weeks per year)

     * Training and Development

     * Flexible Spending Plan

     * Commuter Benefits through wageworks.com

     * Vacation Benefits 

403B Retirement Savings Plan         (eligible at 6 months for 4% match)

* Health Insurance provided by United Healthcare (100% paid by LRA for employee as of

  the day of hire)  

     * Holidays (11+ per year…

Location

Remote
Work may be performed anywhere in United States
Associated Location
275 Madison Avenue, New York, NY 10016, United States
10th FLoor

How to Apply

To apply please email a cover letter, salary requirements and a resume—in this order, in a single pdf file—to:

HR@lupusresearch.org. Incomplete applications will not be considered.


Only applicants who advance to the next stage of considerations will be contacted.


No phone calls please.

To apply please email a cover letter, salary requirements and a resume—in this order, in a single pdf file—to:

HR@lupusresearch.org. Incomplete applications will not be considered…

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