Location

Cambridge, MA
United States

Associate Director, Clinical Operations

COMPANY OVERVIEW

AIRNA is a biotechnology company with a mission to be the leading RNA editing company delivering precision therapies to patients with rare and common diseases.

AIRNA is harnessing advances in genetics to develop transformative RNA-editing medicines that improve human health. Our proprietary platform is based on groundbreaking research by pioneers of the field and company co-founders Thorsten Stafforst (University of Tübingen) and Jin Billy Li (Stanford University) and enables optimal potency, safety, and delivery. AIRNA is advancing a robust pipeline of therapeutic candidates that are designed to provide functional cures for severe or chronic diseases by repairing harmful genetic variants or introducing beneficial variants promote optimal health.

AIRNA has raised $245 million in financing from a world-class syndicate of investors including Arch Venture Partners, Forbion, Venrock Healthcare Capital Partners, RTW Investments, Nextech Invest, and ND Capital. We value teamwork, resilience, excellence, human, and health, and have a diverse team at both our headquarters in Cambridge, MA and our research operations in Tübingen, Germany.

JOB OVERVIEW

The Associate Director of Clinical Operations will lead the planning, execution, and oversight of clinical trials across all phases of development. This individual will be responsible for ensuring trials are conducted on time, within budget, and in compliance with ICH GCP, regulatory requirements, and company SOPs. The Associate Director will play a key role in planning, team leadership, and vendor management, contributing to the overall success of the clinical development programs.

RESPONSIBILITIES

  • Lead the operational execution, overseeing day-to-day operations of global clinical trials (Phase 1–3) from protocol development through study closeout.
  • Collaborate with cross-functional teams to align clinical trial objectives with company goals.
  • Oversee the selection, management, and performance of CROs and other clinical vendors.
  • Build relationships with clinical trial sites and clinical vendors to support patient enrollment.
  • Develop and manage clinical trial budgets and timelines.
  • Ensure high-quality execution of clinical studies in compliance with ICH-GCP, regulatory guidelines, and internal SOPs.
  • Contribute to clinical study design, protocol development, and clinical study reports (CSRs).
  • Monitor study progress and proactively identify and report issues and mitigate risks.
  • Support regulatory filings and interactions, including INDs and CTAs.
  • Present study updates to senior leadership and other internal stakeholders.

QUALIFICATIONS

  • Bachelor’s degree in a relevant scientific or healthcare discipline. RN, MPH, MS, MA, MBA, PharmD, preferred, with 8+ years of clinical operations experience, including 4+ years managing clinical trials and leading cross-functional teams, internal and external.
  • Strong knowledge of FDA regulations, ICH-GCP, and international clinical trial guidelines.
  • Proven experience managing complex global clinical trials.
  • Demonstrated ability to manage CROs and clinical vendors effectively.
  • Excellent organizational, leadership, and communication skills.
  • The ability to work in a fast-paced, dynamic environment with a hands-on approach.
  • Interested in mentoring clinical operations team members.
  • Willing and able to travel up to 20%

PREFERRED QUALIFICATIONS

  • Experience in early-phase development or rare disease.
  • Prior experience in a startup or small biotech environment.
  • Familiarity with eTMF, CTMS, and other clinical systems.
  • Significant experience with EU CTR.
  • Familiarity with Project Management tools (e.g. Thinkcell, Smartsheet)

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.  

To apply for for this position, please send your cover letter and CV to careers@airna.com.

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