Vice President of Clinical Operations

Research & Development Cambridge, Massachusetts


Description

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 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

Reporting to the Chief Medical Officer of Repertoire, the VP of Clinical Operations will be accountable for the resourcing, development, training and management of the company’s clinical operations team.  The ideal candidate will have strong clinical, leadership and communication skills. In addition, the VP will be a hands-on leader willing to roll-up their sleeves to ensure the highest quality of work output. Experience in the cell therapy space is desired as the initial products under clinical evaluation are autologous T cells for the treatment of solid tumors.

Key Responsibilities

  • Provide direct oversight and management of operations and personnel involved in clinical operations, data management, medical writing and other functional groups or external vendors as assigned.
  • Ensure that clinical trials are properly resourced, managed and executed in accordance with timelines and good quality practices.
  • Provide operational and clinical expertise and strategic insights to develop a life-cycle strategy and evaluation of new programs to be prioritized or advanced into clinical development.
  • Participate in the review, planning, and implementation of clinical trials, including evaluating hypothesis, objectives, study design, feasibility, regulatory requirements, and identifying medical and logistical problems that may impede the study.
  • Develop clinical timelines, performance indicators and budget forecasts and be accountable for tracking and delivering accordingly.
  • Represent all aspects of Clinical Operations and provide updates as required to the Executive Team, Project Teams, Board of Directors, and other key internal stakeholders.
  • Ensure the effective and constructive integration of clinical operations knowledge and expertise into all applicable Clinical Development activities including integrated development plans and study protocols at Repertoire; interact and collaborate with other department heads as appropriate.
  • Provide support for regulatory submissions, supporting dossier development and participating

in interactions with FDA and other regulatory agencies, particularly with cell therapy products.

  • Keep abreast of competitive regulatory and clinical practices and utilize this knowledge during

the ongoing development and adjustment of plans.

  • Review master service agreements, statements of work, and quality agreements relating to clinical operations.
  • Implement best practices and standards for trial management in collaboration with other members of the clinical operations team, including establishment of SOPs.
  • Lead initiatives to build clinical department infrastructure.
  • Ensure that clinical trials are conducted in compliance with applicable regulatory requirements and are inspection ready.
  • Plan clinical headcount and hiring needs to meet program workload demands, supporting and mentoring the team for their career development.
  • Support and mentor the Clinical Operations team, including providing guidance and resources for career development.

 

Qualifications/Experience

  • Bachelors in Life Science; an advanced degree (MS or PharmD) is preferred.
  • A minimum of 15 years of experience with expertise in the areas of clinical operations development and strategic planning; developing, implementing, and leading early to late-stage clinical trials.
  • Experience conducting clinical trials with cell therapy products in the context of immuno-oncology is highly preferred.
  • In-depth understanding and experience across the clinical operations value chain, with a track

record of success in study planning, execution, data cleaning, database locking, study report

generation and regulatory inspection.

  • Experience with drug development and NDA filing is preferred, experience in developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and

safety documents preferred.

  • Experience with clinical data management and pharmacovigilance is a plus.
  • Expertise in clinical operations – demonstrated ability to effectively manage projects and

people.

  • Strong communication and presentation skills-demonstrates strong written and verbal communication skills and ability to relay vision/strong sense of department organization.
  • Experience leading a rapidly changing organization and integrating new personnel is essential,

as well as ability to evaluate and resolve complex problems.

 

 

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.