Medical Director

Location

Cambridge

United States

Medical Director

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.

POSITION OVERVIEW

The Senior Medical Director, Clinical Development will serve as a key clinical leader, providing medical oversight and strategic input across multiple stages of clinical development. Reporting to the CMO, this individual will play an important role in the design, execution, and interpretation of clinical studies while partnering closely with cross-functional teams, including Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, Drug Safety, and Medical Affairs.

The Medical Director will provide hands-on medical monitoring and clinical leadership for assigned programs, including study design and protocol development, data review and interpretation, site and investigator engagement, and proactive management of safety considerations. This individual will also contribute medical expertise to regulatory submissions and participate actively in cross-functional study and development teams to ensure clinical programs are executed with scientific rigor, operational excellence, and a strong focus on patient safety.

The ideal candidate will be a clinically trained physician with significant drug development experience and a demonstrated ability to integrate medical, scientific, operational, and regulatory perspectives. This is an opportunity to take on meaningful clinical leadership responsibilities within a growing, fast-paced biotechnology organization.

RESPONSIBILITIES

• Provide clinical leadership and strategic medical input for assigned clinical development programs and studies.
• Drive the execution of clinical programs and trials in close partnership with Clinical Operations and other cross-functional partners.
• Contribute to study design, protocol development, clinical development plans, and other key clinical deliverables.
• Serve as the medical monitor for assigned studies, including oversight of study conduct, safety, data review, cleaning, analysis, and interpretation.
• Contribute to regulatory documents and submissions, including clinical sections of INDs, CTAs, safety reports, responses to regulatory authorities and ethics committees/IRBs, and other relevant materials.
• Ensure scientific rigor, sound clinical judgment, and innovation are incorporated into clinical development strategy and execution.
• Provide medical input into broader clinical development strategy and protocol reviews.
• Partner closely with Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Drug Safety, and Medical Affairs to ensure an integrated approach to study execution and oversight.
• Establish strong relationships with study investigators, external medical experts, key opinion leaders, advisors, and other external partners.
• Represent the organization at investigator meetings, advisory boards, and other scientific or clinical forums as appropriate.
• Support the identification, assessment, and resolution of clinical and safety-related issues throughout study execution.
• Provide mentorship and guidance to less experienced clinical development team members as appropriate.

QUALIFICATIONS

Education: MD or equivalent medical degree required.

• Minimum of 5 years of experience in clinical research or drug development within the biotechnology or pharmaceutical industry, or relevant experience as a clinical study investigator.
• Demonstrated experience designing, implementing, and conducting clinical trials, with hands-on involvement in mid- to late-stage clinical development preferred.
• Proven ability to interpret, discuss, and present clinical efficacy and safety data.
• Strong understanding of clinical trial design, Good Clinical Practice (GCP), statistics, and regulatory and clinical development processes.
• Experience authoring or contributing to regulatory documents and submissions, with exposure to IND and marketing application processes preferred.
• Demonstrated ability to establish effective scientific partnerships with investigators, external experts, and other key stakeholders.
• Strong ability to integrate medical, scientific, regulatory, and operational considerations into clinical development decisions.
• Ability to communicate effectively and work both independently and collaboratively across functions and disciplines.
• Excellent written, verbal, and presentation skills.
• Strong critical thinking, troubleshooting, and problem-solving capabilities.
• Strong organizational, project management, and leadership skills.
• Ability to effectively manage competing priorities in a fast-paced, growing environment with limited oversight.
• Demonstrated ability to influence stakeholders and work effectively with colleagues across all levels of an organization.
• Experience mentoring or providing guidance to less experienced clinical development professionals preferred.

LOCATION: Hybrid - 3 days a week in Cambridge, MA