Associate Director/Director, Product Development
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.


We are looking for a hands-on Associate Director/Director, Product Development to drive the design and development of a novel transmucosal therapeutic combination product.  The successful candidate will have prior experience bringing products from an R&D stage through development and into commercialization, including managing critical vendors.  They will work directly with the Vice President of R&D, provide mentoring to junior engineers, thrive in a fast-paced start-up environment and be adaptable to work on several aspects of product development simultaneously.


Responsibilities

  • Lead the design, development and verification of Lyra’s new products
  • Oversee delivery system concept design and prototyping using bench test methods, pre-clinical studies and physician input to help drive user requirements and product specifications
  • Identify and manage external design firms, contract manufacturers and suppliers
  • Partner with physicians to develop user requirements and assess human factors/usability aspects of Lyra products
  • Serve as a role model and subject matter expert to support implementation and documentation of design control deliverables to support product commercialization
  • Develop project schedules, budgets, and high-level communications to senior management 
  • Work in collaboration with Lyra program teams to integrate product development plans, budgets and timelines into overall program strategy
  • Develop quality documents including creation of FMEA's, design verification protocols, test methods, process validation plans and reports 
  • Lead and document design validation efforts to ensure products meet user needs
  • Support regulatory submission materials and responds to regulatory agencies
  • Work with clinical and marketing to research customer needs and develop product launch materials
  • Work in collaboration with the clinical field specialists and eventually salesforce to provide training and proctor support to physicians on device use and procedure techniques 
Requirements
  • B.S. or M.S. degree in an engineering discipline with 15 or more years of industry experience in the development and commercialization of medical devices or combination products
  • Track record of bringing new products to market. Has led both new product development and sustaining engineering
  • Experience in mentoring and developing engineers
  • Strategic and technical hands-on as necessary
  • Knowledge and experience in test method development, validation, and execution
  • Experience and working knowledge of the U.S. and International standards governing the design, development and manufacture of medical devices.
  • Experience working with physicians to define user requirements
  • Ability to support multiple projects simultaneously, prioritize assignments, and adapt in a fast-paced environment
  • Program management skills including generating project schedules and budgets
  • Areas of expertise: ENT, specifically sinus procedures, mechanical device design considered a plus
  • Excellent written and verbal communication skills
  • Collaborative team player who enjoys working in a highly dynamic cross-disciplinary environment

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.