Director Clinical Development

About the role

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.

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
• 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

• Full range of health benefits, including Medical, Dental & Vision
• Employee Stock Purchase Program (ESPP)
• Competitive salaries and bonus plans plus equity via Stock Options
• Free variety of snacks and beverages
• Health and Wellness programs
• $100 Anniversary cash awards with opportunity to increase to $2000!
• Referral Bonuses
• Company sponsored FUN events