Associate Manager, Clinical Projects

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company focused on the development of cell therapies for a broad range of cancers.

Tessa’s clinical pipeline derives from  two innovative cell therapy platforms; CD30 Chimeric Antigen Receptors (CD30-CARs) and Virus-Specific T cells (VSTs). Our lead candidate comprises autologous CD30 CAR-T cell therapy targeting classical Hodgkin lymphoma (cHL) and CD30+ non-Hodgkin lymphomas.

Tessa is also developing a novel, allogeneic platform technology, as a new approach to traditional cell therapy. By combining the unique properties CD30-CARs and VSTs, the platform holds potential for the creation of next-generation off-the-shelf cell therapies against a variety of hematologic malignancies and solid tumors.

Tessa’s state-of-the-art GMP cell therapy manufacturing facility will open in early 2021, and will substantially enhance in-house production capabilities. Tessa is focused on rapidly and reliably providing safe, effective treatment options for patients.

Job Position
Associate Manager, Clinical Projects

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, 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.

Responsibilities

  • 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.
  • Oversees the execution and adherence to all integrated study operation plans, with inputs from key stakeholders.
  • Work closely with the CRO to manage global sites
  • Monitor KPIs and 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 key participating sites and be the point of sponsor contact escalated site issues.
  • Conduct regular onsite monitor assessment visits.
  • Required to travel up to 30% of the job, when situation permits.
  • Provide inputs into site audit report responses and responsible for oversight of associated plans

Requirements

  • Bachelor’s Degree in a field of Biomedical science, pharmacy, nursing, or medical related courses with at least 7 years’ experience working in clinical research and at least 2 years of experience leading clinical operations related work in oncology studies.
  • In depth knowledge of oncology trials requirements, clinical research principles such as ICH GCP as well as regulatory requirements.
  • Experiences in immuno-oncology and/or gene and cell therapy studies are advantages.
  • 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
  • Proficiency in MS Excel required.