Manager, Clinical Operations
Job Type
Full-time
Description

Lyra Therapeutics, Inc. is a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, local delivery of medications to diseased tissues not accessible with conventional therapeutic approaches. Lyra's XTreo™ platform is comprised of a biocompatible mesh scaffold, an engineered elastomeric matrix and a versatile polymer-drug complex. The company's current pipeline of therapeutics target tissues deep in the ear, nose and throat passages and are designed to deliver continuous drug therapy for up to six months following a single non-invasive, in-office administration. Lyra's lead product candidate, LYR-210, has initiated a Phase 3 clinical trial for the treatment of chronic rhinosinusitis (CRS) as an alternative to primary sinus surgery. Lyra's second product candidate, LYR-220, is entering Phase 3 clinical development and is designed to be an alternative to revision CRS sinus surgery and post-surgical medical management.  Headquartered in the Boston area, Lyra Therapeutics was founded by George Whitesides and Robert Langer, academic luminaries in the fields of chemistry, materials science and biotechnology.


Our team is growing and we are seeking an experienced and energetic Manager, Clinical Operations to lead Lyra’s Phase 3 clinical trials in chronic rhinosinusitis (CRS).  This position reports to the Senior Director, Clinical Operations.  The successful candidate will manage all aspects of the Phase 3 clinical trials and must have excellent communication skills and the ability to work independently in a highly interactive and fast-paced environment.


Responsibilities

  • Manage all aspects of CRO/vendor selection, including request for proposal, CRO evaluation and selection
  • Manage all aspects of clinical trials from study start-up to close-out while adhering to FDA, EMEA, GCP, and ICH guidelines
  • Oversee CRO and vendor activities, including day-to-day management as well as review of metrics/key performance indicators (KPIs)
  • Participate in start-up activities to ensure efficient and accurate study timelines and timely site activation
  • Review and contribute to authorship of clinical study protocols, informed consent forms (ICFs), study manuals, clinical study reports (CSRs) and other clinical documents, as necessary
  • Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationship
  • Attend monitoring visits as needed 
  • Effectively communicate and interact with Key Opinion Leaders
  • Collaborate with the cross-functional team at Lyra to ensure close communication and accurate planning for upcoming and/or ongoing studies
  • Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings 
  • Facilitate risk assessment planning and timely resolution of issues
  • Participate in Case Report Form design, user acceptance testing in partnership with the CRO
Requirements
  • Bachelor’s degree in life sciences or healthcare related field
  • At least 5 years clinical research experience in a CRO or pharmaceutical company, with at least 3 years direct experience managing complex, international studies 
  • Experience managing Phase 3 trials
  • Proven experience overseeing CROs and managing all operational aspects of clinical studies
  • Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close-out procedures
  • Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations as required
  • Experience working closely with study sites, Key Opinion Leaders (KOLs) and external vendors
  • Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines
  • Proven ability to work independently, take initiative, and effectively handle multiple priorities
  • Excellent interpersonal/team skills, strong organizational skills 
  • Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required
  • Ability to travel up to 20%

At Lyra, we value creativity, leadership, and collaboration.  The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable.  We offer a competitive compensation and benefit package with opportunities to join a fast-paced, high performing team.  For consideration, please submit cover letter and CV.  Please visit www.lyratx.com for more information.