Senior Manager / Manager, Clinical Project (New Jersey)

Company Background

Tessa Therapeutics is a clinical-stage immunotherapy company focused on the development of autologous and off-the-shelf, allogeneic therapies targeting solid tumors. Tessa’s Virus-Specific T cell (VST) platform harnesses the body’s potent anti-viral immune response and has shown compelling results in the treatment of solid tumors.

Tessa is building a portfolio of innovative, next-generation therapies by combining the qualities of VSTs with other immuno-oncology technologies. This includes a rapidly growing pipeline of clinical and pre-clinical autologous programs that target a wide range of cancers, including nasopharyngeal carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer, bladder cancer, as well as head and neck cancer. In addition, Tessa is leveraging its platform to develop an allogeneic therapy to address Epstein-Barr virus (EBV)-associated lymphomas.

Tessa has built up robust operational and supply chain capabilities to successfully deliver T cell therapy treatments to a large patient pool worldwide. Together with the Company’s academic, clinical, and commercial research partners, Tessa has created a fully-integrated approach to the treatment of cancer with immunotherapy.

Our mission is to cure cancers and save lives with our innovative and widely accessible immunotherapies. We are looking for highly motivated and enthusiastic individuals who are interested to be part of our team.

Job Position
Senior Manager / Manager, Clinical Project

Reports To

Associate Director, Clinical Operations

Position Summary

This individual will be responsible for the planning and executing of trials for the Clinical Operations function. He/she will work closely with multi-disciplinary departments and will require a solid understanding of the clinical trial lifecycle management such as study startup, feasibility, site selection, patient recruitment, project management, site management and site quality oversight. He/she will also be overseeing CROs and other related third-party vendors which are delegated to execute studies on Tessa’s behalf.

Job Descriptions:

  • Ensure that global clinical strategies are translated to study specific strategies.
  • Ensure that the trials are run in adherence to all relevant regulations including GCP, ICH, local regulatory requirements, as well as SOPs and policies.
  • Provide operational input into study designs, protocols and study plans to ensure that they are operationally feasible at the country, site, and patient levels
  • Oversees the execution and adherence to all integrated study operation plans, with inputs from key stakeholders.
  • Oversee the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with CRO Management and key stake holders
  • Set Key Performance Indicators (KPIs) and roll out metrics to track the quality and performance of the studies.
  • Monitor study progress, study budget, study timeline
  • Identify quality and deliverable risks, roll mitigation plans together with the relevant stakeholders, to ensure risks are minimized.
  • Establish good working relationships with the participating sites and be the point of sponsor contact escalated site issues.
  • Conduct regular onsite monitor assessment visits.
  • Provide inputs into responses for site audit report and Inspection report as well as be responsible for oversight of associated plans

Requirements

  • Bachelor Degree in a field of Biomedical science, pharmacy, nursing, or medical related courses.
  • At least 10 years’ experience working in clinical research and at least 4 years of clinical project management experience in oncology studies.
  • In depth knowledge of oncology trials requirements, clinical research principles such as ICH GCP as well as regulatory requirements.
  • Strong communication and influencing skills
  • Strong organizational and problem-solving skills
  • Strong supervision and oversight skills
  • Effective presentation skills
  • Strong ability to deliver results to the appropriate quality and timeline metrics
  • Good judgment
  • Ability to manage competing priorities
  • Experiences in immuno-oncology and/or gene and cell therapy studies are advantages.
  • Proficiency in MS Excel required, programming knowledge an advantage