Clinical Project Manager

Research & Development Cambridge, Massachusetts


Description

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

The Clinical Project Manager will be responsible for overseeing the day-to-day cross-functional activities of an assigned clinical study to ensure deliverables and timelines are met.  This will involve leading a matrix clinical team that includes a mix of internal and external functional experts as well as multiple external vendors.

Key Responsibilities

  • Develop timelines and key risks for study activities from study start-up through study close out.
  • Lead internal clinical team meetings.
  • Work with the Program Team Leader to ensure clinical timelines and risks are integrated into the overall project plan.
  • Collaborate with other clinical programs and the Head of Clinical Operations to ensure cross team learnings and efficiencies are incorporated across clinical studies.
  • Mentor junior clinical ops team members including managing their day-to-day activities.
  • Prepare and lead key external meetings, e.g. dose escalation meetings, safety meetings, etc.
  • Oversee the development of study related materials, e.g. training manuals, study plans, study templates, updates to clinicaltrials.gov, etc.
  • Manage external vendors and serve as the main point of escalation across all functions.
  • Review and sign off on monitoring reports.
  • Maintain positive site relationships by ensuring PIs are engaged in scientific and strategic developments of the program.
  • Collaborate with the Medical Lead to complete ongoing data cleaning including reviewing clinical data and patient profiles.
  • Work with the sites and Medical Lead to allocate patients into the appropriate cohorts.
  • Collaborate with Head of Clinical Operations and Finance to develop an overall study budget and financial forecast.
  • Report clinical trial metrics to the Program Team.
  • Ensure study is executed in compliance with internal SOPs and GCP guidelines.
  • Participate in the development of study synopses, study protocols, and protocol amendments including being the primary author.
  • Collaborate in the development of the investigator’s brochure and IND/DSUR annual reports.
  • Work closely with supply chain regarding the logistics around the delivery of the drug product.

Qualifications/Experience

  • Bachelor’s degree required.
  • 5 plus years of pharma/sponsor clinical trial. management/execution with experience in oncology and/or cell therapy space.
  • Excellent verbal and written communication skills.
  • Strong regulatory knowledge including Good Clinical Practices (GCPs).
  • Exceptional organizational skills and ability to deal with competing priorities as well as strong reasoning and problem-solving ability.

 

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.