Clinical Project Manager (New Jersey)

About Tessa Therapeutics

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

Clinical Project Manager (New Jersey)

Position Summary

This individual will be responsible for overseeing and executing of trials for the Clinical Operations function for the assigned studies in the US. 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 evaluation, monitoring and site management. 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

  • Drive global clinical strategies into regional specific strategies.
  • Oversee that trials are run in adherence to all relevant regulations including ICH GCP, local regulatory requirements, as well as SOPs and policies.
  • Provide operational input into 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.
  • Be accountable of the study performance matrix, according to KPIs set.
  • Monitor study progress, study budget, study timeline
  • Identify quality and deliverable risks and issues, roll mitigation plans together with the relevant stakeholders (including CRO and third party vendor), to ensure those are minimized.
  • Establish good working relationships with the participating sites and be the point of sponsor contact for escalated site issues.
  • Conduct regular onsite co-monitoring visits and other accompanied visits, overseeing that CRAs are conducting the study visits appropriately.
  • Provide inputs into responses for site audit report and Inspection report as well as be responsible for oversight of associated plans

Requirements

  • Bachelor’s Degree or Graduate Degree in a field of science or nursing, preferably biology, chemistry, pharmacy, or other field related to human study
  • At least 6 years’ experience working in clinical research including at least 2 years of clinical project management or clinical trial management experience in oncology studies and at least 2 years of onsite monitoring experience 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 ability to deliver results to the appropriate quality and timeline metrics
  • Proficiency in MS Excel required, programming knowledge an advantage