Background

Cartherics Pty Ltd is a private company based in Melbourne, Australia, developing novel, cell-based therapies for the treatment of cancer.  Cartherics offices and laboratories are presently located at the Monash Health Translation Precinct (MHTP) located on the Monash Medical Centre campus.  The Company has been in operation since the beginning of 2016 and it currently employs 16 scientific staff and 6 consultants.  The Company is well financed through private investment and government grants.

The Company’s primary objective is to develop “off-the-shelf”, allogeneic cell therapies derived from induced pluripotent stem cells (iPSCs).  The first allogeneic product (CTH-401) is an iPSC-derived, NK cell product.  The CTH-401 team is currently validating its research scale manufacturing process with a view to transferring a prototype method to Cartherics’ manufacturing partner, Cell Therapies Pty Ltd, during 2020.

While the Company’s main focus is directed towards the development of a portfolio of allogeneic products, its CAR constructs, when introduced into human donor T cells, have proven to be extremely efficacious in in vivo murine tumor models.  This has created the prospect for establishing human proof-of-concept for its CAR constructs using patient-derived T cells (i.e. autologous treatments).  Cartherics is working on two potential autologous products, CTH-001 for the treatment of cutaneous T cell lymphoma (CTCL) and CTH-004 for the treatment of relapsed and refractory ovarian cancer.  The Company is currently validating methods of manufacture for each of these products for transfer to Cell Therapies.

Cartherics’ regulatory strategy is to conduct its clinical trials under an IND with the FDA, although the sites for its initial clinical studies are planned to be in Australia.  Subject to regulatory advice and feedback from the FDA, the company intends to file its first IND application in 2021.

 Project Manager Position Description

In order to support and facilitate development of CTH-001, CTH-004 and CTH-401, Cartherics is looking to employ an experienced, full-time Project Manager.  Each of the three projects has a Lead Scientist responsible for oversight and direction of the research and development program.  The Project Manager will work closely with and support each of these Lead Scientists in planning, overseeing and leading the projects through the development process, and with the broader development team in generating clinical and regulatory documentation. This is a senior role requiring a multi-skilled and highly capable individual.

Duties and Responsibilities

The Project Manager’s role will include the following:

  • Leading project planning sessions and overseeing the project plan
  • Coordinating staff and internal resources required for efficient project execution
  • Monitoring project progress and ensuring essential reports are completed and filed
  • Ensuring projects meet agreed deadlines
  • Managing relationships with internal (e.g. Cartherics management) and external stakeholders (e.g. regulatory advisors, consultants and contracted providers)
  • Reviewing relevant contracts
  • Overseeing relevant incoming and outgoing project documentation
  • Designing risk mitigation plan
  • Conducting project reviews and creating detailed reports for management
  • As necessary, preparing or providing support for the preparation of project documentation (such as study reports, SOPs, regulatory filings).

Qualifications and Requirements

The successful candidate will require relevant qualifications and experience, including:

  • A science degree (minimally a BSc or equivalent; preferably a PhD or MBA in addition)
  • Significant (5 years minimum) prior experience in drug development, ideally in a biotechnology or pharmaceutical company
  • Prior project management experience, including familiarity with project management software.

Additionally, the successful candidate will need to be proficient in the following skills:

  • Written and verbal communication
  • Capacity to manage high stress situations
  • Ability to multi-task and manage various project elements simultaneously
  • Leadership skills
  • Both big-picture thinking and attention to detail
  • Conflict resolution.

Reporting

The Project Manager’s line manager will be the Company’s Corporate Advisor but the Project Manager will report indirectly to the CEO and the Board as required.

Employment Conditions

Cartherics provides a stimulating, highly professional and cohesive work environment in a first-class facility.  The Company will provide a competitive salary, anticipated in the ~$130,000 p.a. range plus 9.5% superannuation, consistent with the successful candidate’s qualifications and expertise.  The Project Manager will be eligible to participate in the Company’s Employee Share Option Program (ESOP).  The Project Manager will have the opportunity for on-the-job training and development, working alongside experienced scientific and business staff.

If you are interested please send a cover letter and your resume (including potential referees) to Karen Loudon karen.loudon@hudson.org.au by the closing date of Wednesday 25 March 2020.