Director of Clinical Operations

Talaris Therapeutics, Inc.(“Talaris”) is developing a breakthrough, one-time cell therapy to enable patients who receive a living donor kidney transplant to no longer require lifelong immunosuppression, without rejecting their donated organ. Achieving durable, drug-free immune tolerance to a donated organ has been referred to as a “Holy Grail” of organ transplant. In a ground-breaking, phase 2 study conducted between 2008 – 2016, our lead therapy, FCR001, enabled 70% of patients to be weaned off all immunosuppression within 12 months of their kidney transplant. No tolerized patient has had to resume immunosuppression. We have followed these patients for an average of almost five years since their transplant, and the longest for over ten years. Our single-dose cell therapy has also shown the potential to induce durable remission of certain types of severe auto-immune diseases, and to benefit other solid organ transplant patients. Talaris has announced a $100M private financing from leading life sciences investors and has initiated a Phase 3 pivotal trial of our therapy in living donor kidney transplant patients. We also expect to initiate two Phase 2 trials of our therapy in additional indications in 2020. Our cell processing facility and most of our operations are based in Louisville, KY, and we also have a corporate office in Boston, MA.

Theclinical operations directoris accountable for planning and executing the Talaris clinical trial from operational planning through trial close-out, in compliance with Talaris processes, GCP/ICH and regulatory requirements. This role will report directly to our clinical head of operations and offers the flexibility to work remotely.

Responsibilities:

  • Management and oversight of all phases of study execution from site feasibility through study closure
  • Management and oversight of CRO and vendors supporting clinical program including the development of eCRFs, study manuals, plans and procedures
  • Work collaboratively in a cross functional team environment with partners supporting Clinical, CMC, Research, Regulatory Affairs, Legal and Finance
  • Author protocol, amendments, ICFs and site budgets
  • Review and approval of site ICFs and budgets
  • Creation of training materials and matrices for vendor and clinical sites; ensure maintenance of training records
  • Oversight of the eTMF and ensure maintenance of all study documentation
  • Resolution and escalation of issues impacting study execution; manage corrective action when needed
  • Provide guidance, direction and management to CRAs; ensure compliance with GCP and study protocol
  • Work to achieve all deliverables on time, within budget, at the expected level of quality Ensure key metrics are in place and hold vendors accountable for their deliverables
  • Support clinical team as needed on safety events and risk management
  • Attend site visits as needed
  • Support regulatory filings as needed
  • Mentor/onboard new team members

Qualifications

  • Requires a BS in the health or life sciences or equivalent
  • 7+ years of clinical operations experience in a pharmaceutical, biotech and/or contract research organization (CRO) setting; including management of a CRO
  • Strong leadership, collaborative and interpersonal skills with proven ability to build strong relationships with CROs/vendors
  • Experienced working independently and in a team environment with ability to adapt to changing priorities and deadlines,
  • Analytical thinker with excellent problem-solving skills
  • In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Excellent computer skills (Microsoft Office Suite, Electronic Data Capture and Trial Master File Systems)
  • Ability to travel up to 30%

Apply: Please submit resume or CV and cover letter to hiring@Talaristx.com

Talaris is an equal opportunity employer and prohibits unlawful discrimination.