Senior Clinical Project Manager

Biotechnology 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.  The company is also using its DECODE platform to discover infectious disease antigens and responding T cell clones.

Role Overview

The successful candidate will be responsible for all aspects of clinical trial management for Repertoire Immune Medicines novel T cell therapy-based approach for the treatment of cancer and other autoimmune diseases.  Responsibilities include study planning and execution, timelines, budget, and vendor management.  You will also be responsible for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning.  The ideal candidate must be comfortable working independently, managing interactions with and between team members, both internally and externally.  You will ensure trial(s) are managed to the highest quality to ensure safety and effectiveness of Repertoire’s products.

Key Responsibilities

  • Develop timelines and key risks for study activities from study start-up through study close out.
  • Lead internal clinical team meetings.
  • 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.
  • Work with the program team leader to ensure clinical timelines and risks are integrated into the overall project plan.
  • Perform clinical research site activities such as on-site or remote monitoring, co-monitoring, training, and motivational visits, as needed.
  • Manage external vendors and serve as the main point of escalation across all functions.
  • Maintain positive site relationships by ensuring PIs are engaged in scientific and strategic developments of the program.
  • Collaborate with other clinical programs and the VP, Clinical Development Operations to ensure cross team learnings and efficiencies are incorporated across clinical studies.
  • Collaborate with the Medical Lead to complete ongoing data cleaning including review of clinical data and patient profiles.
  • Work with the sites and Medical Lead to allocate patients into the appropriate cohorts.
  • Collaborate with the VP, Clinical Development Operations and Finance to develop an overall study budget and financial forecast.
  • Track and report clinical trial metrics.
  • Mentor junior members of the clinical team.
  • Ensure studies are executed in compliance with applicable 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 the supply chain regarding the logistics around the delivery of the drug product.

Qualifications/Experience

  • B.S./B.A./R.N. degree in science or a health-related field is preferred.
  • Minimum of 7 years relevant industry clinical development experience; experience with complex therapeutic platforms and/or cell therapy clinical trials preferred.
  • Experience with all aspects of trial and site startup and vendor management.
  • Excellent knowledge of GCP, ICH, and FDA regulations.
  • Familiarity with clinical data review and data management processes including Data Monitoring Safety Committees.
  • Must be able to travel up to 20% domestically and internationally.
  • Strong verbal and written communication skills.
  • Ability to deal with competing priorities, strong reasoning, detail oriented, and creative problem-solving ability is essential.
  • Ability to work on teams with aggressive timelines and to multi-task in a fast-paced environment with changing priorities.
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.

 

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.