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Director Program Management

1 month ago

Cambridge, United States AIRNA Full time

COMPANY OVERVIEW

AIRNA is a biotechnology company with a mission to transform lives, one RNA edit at a time. AIRNA aspires to deliver the promise of base editing to patients with rare and common diseases by pioneering the discovery and development of RNA editing therapeutics. RNA editing addresses the root cause biology of diseases by making a single base edit to RNA with a safe, temporary, and potent drug product. AIRNA’s founders were the first to demonstrate precise editing of RNA using oligonucleotides, and the company is pursuing a broad pipeline of medicines with its proprietary RESTORE+ platform. AIRNA has been well financed by world class venture capital firms, including Arch Venture Partners, and is headquartered in Cambridge, MA with research operations in Tübingen, Germany.

JOB DESCRIPTION

Reporting to the CEO, we seek a highly creative and experienced program manager to coordinate and lead the cross-functional program team responsible for bringing its lead program into successful first-in-human clinical trials. This role will work closely with the CSO, clinical, manufacturing, and other functions to develop and execute on plans to drive therapeutic candidates into clinical trials and beyond. AIRNA is a diverse team of positive, energetic individuals passionate about transforming lives through our science, and we are looking for a team player willing to roll up their sleeves to help the company be successful.

RESPONSIBILITIES

The successful candidate will have prior program management experience, have led multiple clinical stage program planning, coordinated IND writing, as well as contributed to overall program strategy. The ideal candidate will have experience coordinating cross-functional teams to deliver on results ahead of schedule and on budget.

  • Responsible for developing overall, cross-functional plan for bringing programs to development candidate nomination, IND submission and early clinical trials
  • Partner with internal and external stakeholders to ensure optimal planning and execution with a sense of urgency
  • Set program priorities and budget together with leadership, set and manage deadlines and budget, effectively anticipate problems, and lead resolution efforts to issues as they arise
  • Pro-actively identify critical path activities, key inter-dependencies, as well as program risks, and implement mitigation strategies
  • Manage program meetings and prepare agendas and minutes and follow-up on action items
  • Track program activities and documentation associated with manufacturing, IND enabling studies, and IND filing. This may include CRO management
  • Effectively communicate progress of program to leadership team, and prepare communications to the Board of Directors and external parties (investors, potential partners)
  • Take on special projects at the direction of the CEO or CSO


QUALIFICATIONS

Requires a BS or MS in life sciences or related area (advanced degree e.g. PhD, MD preferred)

8+ year’s experience working in a biopharma company or biopharma consulting company

Proven experience and track record in program management with demonstrated success writing and filing IND(s). Experience with oligonucleotides is preferred

Experience with program management of programs at both pre-clinical and clinical stages

Deep understanding of drug development and program planning including GxP and regulatory requirements

Expertise in the use of program management tools, MS Powerpoint, and Excel

Understanding of risk management and experience establishing mitigation strategies

Positive, collaborative and committed team member

LOCATION:

AIRNA has a hybrid work model, and the role will be based in AIRNA’s corporate headquarters in Cambridge, MA ~3 days per week.