Director/Senior Director, Pulmonary and Rare Diseases Clinical Development

SUMMARY

The Director/Senior Director, Pulmonary and Rare Diseases Clinical Development, will report to the Executive Medical Director. This role provides medical and scientific leadership to assigned programs within the franchise. The Director will contribute to the design and execution of clinical development plans, serve as Medical Monitor for clinical trials, and collaborate cross-functionally to ensure high-quality clinical deliverables. The Director will engage with investigators, KOLs, and regulatory agencies to advance Arcturus’ programs in cystic fibrosis and other rare pulmonary diseases, and will also have opportunities to contribute to programs in rare liver and metabolic diseases.

RESPONSIBILITIES

• Contribute to the design, maintenance, and execution of clinical development plans under EMD/CMO guidance
• Draft and review core clinical trial documents (protocols, Investigator Brochures, IND submissions, CSRs, etc.)
• Support Medical Monitor for Arcturus-sponsored clinical trials, including safety oversight and data review
• Participate in project team meetings; provide medical input to decision-making and support timely follow-up on action items
• Identify and help mitigate emerging risks in partnership with project management
• Collaborate with regulatory affairs on submissions, responses, and agency interactions
• Engage with investigators, KOLs, and SAB members to inform development strategy and execution
• Deliver scientific presentations to internal teams, investigators, and clinical site staff
• Contribute to manuscripts, abstracts, and presentations for scientific meetings
• Support budget planning and tracking with the Project Manager and Finance
• Mentor and train junior clinical staff as needed
• Stay current on advances in pulmonary and rare disease research and represent Arcturus at scientific/medical meetings
• Ensure compliance with GCP and company policies across all assigned studies
• Contribute to departmental and corporate objectives as assigned

REQUIREMENTS

• Advanced clinical degree (e.g., MD, DO, PharmD, MBBS, RN, RT etc.)
• Clinical training/experience in respiratory/cardiopulmonary medicine preferred; experience in cystic fibrosis and/or rare diseases strongly valued
• 5-7+ years clinical research experience in pharmaceutical/biotech industry or extensive academic clinical research, with knowledge of rare disease drug development desirable. Small biotech/pharma experience also highly welcomed
• Solid understanding of clinical trial design, implementation, and sponsor-site interactions
• Demonstrated experience contributing to cross-functional project teams; leadership of sub-projects or clinical workstreams desirable
• Strong written, oral, and presentation skills with ability to influence cross-functionally
• Experience with regulatory agency interactions (FDA/EMA))
• Collaborative mindset and ability to manage competing priorities in a fast-paced environment
• “Can-do” attitude and willingness to operate hands-on as well as strategically.

WHAT WE OFFER

An exciting opportunity to join a company that offers a competitive total rewards package that includes:

Arcturus is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.