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Repertoire Immune Medicines
Cambridge, Massachusetts, United States
30+ days ago
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Repertoire Immune Medicines
Cambridge, Massachusetts, United States
30+ days ago

Description

Role Overview

A successful candidate will be responsible for overseeing all aspects of clinical data management for Repertoire Immune Medicines novel T cell therapy-based approach for the treatment of cancer, and other serious diseases.  The ideal candidate must be comfortable working independently, managing interactions with and between team members, both internally and externally.  You will ensure that data management activities are performed to the highest quality standards.

As Director of Clinical Data Management, you will be responsible for setting strategy for organizational growth, vendor selection, systems selection and integration with other functions.  In this role you will be tasked with developing SOPs, as appropriate, to support the business, and ensuring compliance with these SOPs to produce quality and timely deliverables.



Requirements

Company Overview

Repertoire Immune Medicines is a clinical-stage biotechnology company working to unlock and direct the remarkable power of the human immune system to prevent or treat cancer, as well as autoimmune and infectious disease.  The company is founded on the belief that the repertoire of T cell receptor (TCR)-antigen codes that drive health and disease represents one of the greatest opportunities for innovation in medical science.  Repertoire scientists created and developed the DECODE and DEPLOY suite of technologies, which allow in-depth characterization of TCR-antigen pairs, and the ability to rationally design and develop novel targeted immune medicines.

From its sites in Cambridge, Mass., and Zurich, Switzerland, Repertoire’s team of more than 120 is creating a new category of immune medicines enabled from its DECODE discovery platform.  The company’s first product in the clinic is a novel multiclonal T cell therapy consisting of T cells derived from the peripheral blood, activated against a curated set of antigens and armed with a proprietary cytokine.  Repertoire is in clinical-stage immuno-oncology development today, targeting metastatic solid tumors.  In the field of autoimmunity, Repertoire is currently using its proprietary platform to discover novel epitopes and TCRs from patients with type 1 diabetes.  However, we are currently expanding our remit into other autoimmune disorders.  The company is also using its DECODE platform to discover infectious disease antigens and responding T cell clones.

Role Overview

A successful candidate will be responsible for overseeing all aspects of clinical data management for Repertoire Immune Medicines novel T cell therapy-based approach for the treatment of cancer, and other serious diseases.  The ideal candidate must be comfortable working independently, managing interactions with and between team members, both internally and externally.  You will ensure that data management activities are performed to the highest quality standards.

As Director of Clinical Data Management, you will be responsible for setting strategy for organizational growth, vendor selection, systems selection and integration with other functions.  In this role you will be tasked with developing SOPs, as appropriate, to support the business, and ensuring compliance with these SOPs to produce quality and timely deliverables.

Key Responsibilities

  • Acting as the main point of contact with data management vendors; overseeing budgets and participating in contract negotiations as well as change in scope amendments for use of systems and personnel.
  • The implementation and maintenance of clinical data systems including electronic data capture (EDC), visualization tools, and clinical data repositories.
  • Defining and gathering departmental metrics, creating standard operating procedures, and generating continuous quality improvement projects.
  • Developing internal as well as external training programs for clinical data systems, as appropriate.
  • Overseeing internal and external audits of clinical data systems.
  • Supervising activities in clinical data management including:
    • Preparing and delivering standard clinical data management documents such as Case Report Forms (CRFs), Data Management Plans (DMP), Data Validation Plans (DVP), Data Quality Plans (DQP), CRF Completion Guidelines, and Edit Check Development and Validation.

Qualifications/Experience

  • Position will be hired based on level of experience.  B.S./B.A. or RN in Science or Health related field with a minimum of 10-12 years of experience in clinical data management within the pharmaceutical/biotech industry; experience in cell therapy a plus.
  • Ability to lead projects and teams (internal and external) to deliver desired outcomes.  High level of facilitation, detail-orientation, project management skills, and influencing strategy.
  • Expertise in core data management activities.
  • Knowledge of GCP and FDA regulatory requirements.
  • Strong, flexible, and impactful communicator.
  • Strong reasoning, detail oriented, and creative problem-solving ability is essential.
  • Self-motivated with the ability to drive exceptional results/outcomes, even with aggressive timelines.

Repertoire is committed towards social responsibility and developing an inclusive culture.  Much as the power of the immune system lies in the diversity of T and B cells, our work requires the creativity and ingenuity of a diverse workforce.  We believe in actively pursuing equity in all facets of the work experience at Repertoire.  We will continue to educate ourselves about the inequities and barriers present in our society and take action as a company where we can make a difference.

Repertoire is proud to be an Equal Opportunity Employer.

Job Information

  • Job ID: 57357478
  • Location:
    Cambridge, Massachusetts, United States
  • Position Title: Director, Clinical Data Management
  • Company Name: Repertoire Immune Medicines
  • Job Function: Clinical,
    Data Management,
    Research
  • Job Type: Full-Time
  • Min Education: BA/BS/Undergraduate
  • Min Experience: Over 10 Years

Please refer to the company's website or job descriptions to learn more about them.

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