Clinical Development Director

Unique opportunity to join an exciting, mid-stage biotechnology company

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. This has been referred to as the “Holy Grail” of organ transplant.  In a ground-breaking, phase 2 study conducted between 2009 – 2016, our lead therapy, FCR001, enabled 70% of patients to be weaned off all immunosuppression within 12 months of their kidney transplant, and not a single patient has had to resume immunosuppression since then.  We have followed these patients for an average of 4.5 years since their transplant, and the longest for over eight years.  Our single-dose cell therapy has also shown the potential to cure certain types of severe auto-immune diseases, and to benefit other solid organ transplant patients. We recently closed a $100M private financing from leading life sciences investors and are in the process of re-naming and re-branding the company prior to publicly announcing our financing.  We will be initiating a Phase 3 pivotal trial of our therapy in living donor kidney transplant patients in mid-2019. We will also be initiating two Phase 2 trials of our therapy in additional indications in early 2020. Our wholly-owned cell processing facility and most of our operations are based in Louisville, KY, and we have also opened an office in Boston, MA.

The Clinical Development Directorwill be responsible for clinical/scientific execution of the clinical protocol, managing scientific aspects of the implementation and conduct of the clinical trial (e.g., site training, safety and medical monitoring, medical review of study data, clinical documents, preparation of responses for ethics committees or regulatory authorities). S/he will primarily be responsible for the autoimmune stem cell transplant program, but will serve as a stem cell transplant advisor to the kidney transplant tolerance program.  Will collaborate in matrix environment with Talaris Clinical and CMC as well as external partners. This newly created role will report directly to the Chief Medical Officer.(CMO).

Responsibilities

  • Develop and maintain close professional relationships with clinical study sites (physicians, nurses, coordinators, other treatment team members)
  • Provide guidance/training for sites as well asexternal partners involved in Talaris’s clinical studies
  • Respond to clinical questions from study sites/health care providers
  • Provide field-based scientific and medical support
  • Develop study specific training material for training to sites, including investigator meetings and site initiation visits
  • Develop and implement effective educational plans to increase scientific awareness and advocacy of FCR001 programs among health care providers in the field
  • Serve as an internal clinical resource for training and educational support
  • Maintain a high level of clinical knowledge around FCR001 programs
  • Oversee with clinical operations team, implementation of patient recruitment and retention strategies, site activation and monitoring visits and acts on any deviations from plan
  • Drive scientific execution of clinical studies to the highest standards, including the support, planning, design, implementation and execution of clinical programs and the design, preparation and initiation of study protocols and other required documentation in compliance with project plans, regulations, Good Clinical Practice (“GCP”) and good medical practice
  • Contribute /provide scientific input to the writing and updating of investigational brochures, protocols, clinical trial reports, IND annual reports, or other study-related documents for accuracy, completeness and comprehension in accordance with SOPs and good medical practices
  • Assist in the preparation of the responses to questions from Health Authorities, IRB/Ethics committees
  • Assist in providing or preparing medical or scientific information/documentation/analysis when appropriate for protocol preparation or study conduct, including interim analyses
  • Attend and provide scientific support of Medical Affairs activities and scientific sessions at congress meetings
  • Assist in ongoing medical and scientific review of clinical trial medical and safety data (including but not limited to SAEs), including safety data reconcillation
  • Help manage organizing steering committees, data monitoring committees, adjudication committee meetings
  • Provide apheresis and FCR001 infusion support to sites, including but not limited to site training and coordination of apheresis with CMC and sites
  • Provide additional job-related dutes as required
  • Assist in accomplishing department and corporate objectives

Qualifications & Requirements

  • Advanced degree in the life sciences/healthcare (or clinically relevant degree) is required. M.D. is preferred.
  • ≥ 3 years of involvement in clinical research or drug development, in all aspects of conducting clinical trials in a matrix environment in the biopharmaceutical industry.
  • Comprehensive and detailed knowledge of clinical trial implementation and sponsor/site interactions for clinical trials
  • Advanced knowledge of therapeutic area (hematology oncology and/or cellular therapy)
  • Thorough knowledge of GCP, clinical trial design, regulatory/clinical development process
  • Excellent communication skills, written and oral
  • Excellent people skills, with demonstrated ability to manage a diverse team and communicate effectively across functional groups
  • Outstanding interpersonal skills, including building strong working relationships, and managing and resolving conflict.
  • Demonstrated ability to establish strong scientific partnership with key stakeholders
  • Ability to work effectively in a fast-paced, rapidly changing environment
  • High level of autonomy and motivation
  • Willingness to have a flexible schedule when needed and travel domestically (+/- 30%)
  • Position can be primarily based out of the candidate’s home

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

Talaris is an equal opportunity employer and prohibits unlawful discrimination.