Sr. Manager/Associate Director, Program Leadership - Waltham, United States - Lyra Therapeutics

Description

Lyra Therapeutics, Inc.

is a clinical-stage biotechnology company developing novel, integrated drug and delivery solutions for the localized treatment of patients with chronic rhinosinusitis (CRS) and other chronic diseases.

Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities.

LYR-210 and LYR-220 are bioresorbable polymeric matrices designed to be administered in a brief, non-invasive, in-office procedure and are intended to deliver up to six months of continuous mometasone furoate drug therapy to the sinonasal passages as an alternative to sinus surgery.

LYR-210 is designed for surgically naïve patients and is being evaluated in the ENLIGHTEN Phase 3 clinical program, while LYR-220, an enlarged matrix, is being evaluated in patients who have recurrent symptoms despite surgery in the BEACON Phase 2 clinical trial.

These two product candidates are designed to treat the estimated four million CRS patients in the United States who fail medical management each year.

We are currently seeking a Senior Manager/ Associate Director, Program Leadership to manage the operational planning, and cross-functional communication for our two lead drug development programs.

The Senior Program Manager will work with the Program Leads to manage the Company's program management planning capability and tools in order to enhance the efficiency and effectiveness of Lyra's program teams.

This position reports to the Associate Vice President, Program Leadership and will work closely with the Program Development Team and Program Development Sub-Teams to manage program activities.

One of the main responsibilities initially will be managing the cross-functional activities to ensure a successful and timely NDA submission.

The ideal candidate is an experienced program manager with 8 or more years of experience in drug and/or combination drug-device development.

Key Areas of Responsibility:
Work with Program Lead and Program Teams to build and maintain project plans for our two lead programs using MS Project or other project management tools
Work with Program Team in the preparation of agendas, meeting minutes, presentation materials, and follow up action items
Maintain tools for communication about project goals and progress (i.e. Egnyte, Office 365 sites)
Track progress of activities and deliverables, manage key program deliverables, and identify program risks and mitigation strategies, and anticipate potential issues
Develop and maintain key program tracking tools for communication with the Senior Leadership Team
Work with the Program Team and Finance to define budgeting and forecasting information utilizing the financial management system
Manage the cross functional NDA deliverables
Support the Program Lead in management of projects to support the Program Management function
Support the development of Program Integrated Development Plans and annual 5-year Long Range Plan

Qualifications:
Bachelor's Degree or higher in a scientific discipline preferred
8+ years of product development program management experience in the pharmaceutical industry
Proven success working in cross-functional teams in a fast paced, entrepreneurial environment
Experience with program management for NDA submissions and familiarity with NDA components
Experience with cross-functional drug development process from clinical phase through commercialization. Medical device development experience is also a plus
Skilled in project management software
Effective communicator with exceptional written and oral communication skills
At Lyra, we value creativity, leadership, and collaboration.

The company sees significant expansion opportunities as we near commercialization, and look for people who are results-focused, innovative, and adaptable.

For consideration, please submit cover letter and CV.
Are you bound by any non-solicitation or non-compete agreement?

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As set forth in Lyra Therapeutics, Inc.'s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

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A "disabled veteran" is one of the following: a veteran of the U.S.

military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S.

military, ground, naval, or air service.
An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S.

military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S.

military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

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