Lyra Therapeutics (Nasdaq: LYRA) is a clinical-stage company pioneering a new therapeutic approach to treat debilitating ear, nose and throat (ENT) diseases that impact the lives of millions of people. Our goal is to transform the ENT treatment paradigm by providing effective front-line solutions for physicians and new treatment options for their patients. In a Phase 1 study, the company observed a rapid, clinically meaningful and durable improvement in symptom score, with 90% of Chronic Rhinosinusitis (CRS) patients having improved symptoms at 24 weeks. A positive Phase 2 study readout of LYR-210 for the treatment of chronic rhinosinusitis with and without nasal polypsis was recently announced and LYR-220 is expected in the clinic next year. 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 programs are moving quickly, and we are currently seeking a Project Manager/Associate Project Manager to handle the planning, and communication for one or more drug development projects. Supporting the Program Manager and key functional leaders to achieve key project commitments, the Project Manager’s primary responsibility will be the technology transfer to our Contract Manufacturing Organization. The ideal candidate is an experienced project manager with 5 or more years of experience in drug development.
Key Areas of Responsibility:
· Project Manage and coordinate one or more cross functional (R&D, Technical Transfer, Clinical, Regulatory, Commercial) development subteams in conjunction with the appropriate functional lead and the overall program manager.
· Establish and maintain overall and subteam project schedules with meaningful timelines and check points, logical links between activities, and internal/external resources.
· Coordinate documentation and reviews to support necessary quality reviews and regulatory submissions.
· Conduct critical path analysis, and participate in evaluation of potential means to accelerate completion of program milestones.
· Provide the team members with project management and drug development expertise and coach and mentor project team members in fulfilling their tasks efficiently.
· Identify and help manage project risks with emphasis on integrating mitigating and preventive actions into plans and schedules.
· Track and forecast tasks and project timelines and provide team with early warnings on possible variances and communicate significant variances to the program team.
· Schedule program and subteam level meetings, help develop meeting agendas. take minutes and ensure follow-up of action items from the minutes. Prepare presentations as needed
Bachelor’s Degree in a scientific discipline required
5+ years of product development experience, at least 3 in the pharmaceutical industry
Strong preference for project management certification (e.g. PMI, IPMA)
Proven success working in cross-functional teams
Familiarity with cross-functional Drug Development Process, preferably including CMC, from clinical phase through commercialization.
Medical device development experience is also a plus
Experience with Drug product technical transfer to a Contract Manufacturing Organization
Skilled in project management, spreadsheet and presentation software
Strong, confident written and oral communicator
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. For consideration, please submit cover letter and CV.
Please visit www.lyratx.com for more information.