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Avalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s lead program, AP01, is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b Study in progressive pulmonary fibrosis (PPF). Avalyn has initiated a Phase 1b study for its second program, AP02, inhaled nintedanib, that is being developed for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn.

Position Overview:

Avalyn is seeking a VP of Program Management to join our team. We are focused on enhancing the lives of patients by developing innovative inhalation therapies to address unmet needs in the treatment of rare respiratory diseases. The Company’s lead asset, inhaled pirfenidone (AP01), is in a Phase 2b study for the treatment of IPF. Avalyn's experienced clinical and inhaled product development team is rapidly advancing AP01 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and other forms of interstitial lung disease (ILD), as well as additional pipeline candidates for other severe respiratory diseases.

As VP of PM, you will assume leadership of the strategic planning and delivery of Avalyn’s pipeline programs. You will lead Program Management for the company, driving the development and implementation across the organization as well as identifying risks and mitigations for overall success. You will lead project management of cross-functional program teams to effectively strategize, plan, and execute on Avalyn’s programs from development candidate selection through clinical development, regulatory submission & approvals, and commercial launch. This position will report to the Chief Operating Officer.

Key Responsibilities:

• The successful candidate will work closely with the COO, SVP of Corporate Planning and Portfolio Strategy and other leaders to shape the R&D portfolio, realize business objectives, and inspire our team to achieve our ambitious goals.
• Partners with cross-functional development program team leaders, provides strategic input on development plans, ensures on-going alignment to project team objectives and overall execution of program deliverables; Acts as sounding board to manage issue resolution and facilitate team’s evaluation and development of recommended strategic plans.
• Develop and execute integrated cross-functional project plans with established goals, milestones, timelines and budget, with a key focus on bringing clinical therapeutic programs into and through clinical development.
• Ensure the objectives and priorities of all team members align with the corporate strategy and drive accountability throughout the team and the Company.
• Delivers program scenarios (cost, time, risks) in collaboration with the team for senior leadership decision-making. Will present business, regulatory and scientific impact of development plan options to a wide range of stakeholders.
• Articulates problems, brings the right people together to solve problems and know when the problem has been properly addressed and closed. Assesses project risk potentials and discover potential problems before they occur.
• Defines, teaches, and enforces the use of good project management practices such as techniques in resolving complex, interdependent activities into tasks and sub-tasks that are documented, monitored, and controlled.
• Communicates to all concerned parties project milestones, status updates, as well as any existing or potential escalation issues.
• May manage, coach, and mentor direct reports.

Key requirements for this role are:

• Bachelor’s degree in life sciences and 15+ years of pharmaceutical industry experience, or a related field. Or Master's degree and 10+ years of experience, or Ph.D./PharmD and 7+ years of experience required
• Proven experience working with rare diseases or respiratory/inhaled medicines is a strong plus.
• Deploys business acumen skills in the context of an emerging biotech company to balance cost, time, resource and regulatory risk of the program.
• Deep understanding of clinical trials, drug development, CMC requirements, and regulatory requirements.