Clinical Operations Manager/Sr Manager/Director - #54716

About Arnatar Therapeutics

Arnatar Therapeutics is a clinical stage, mission-driven biotechnology company advancing transformative RNA medicines using best-in-class antisense technology. We combine deep scientific expertise in RNA biology, medicinal chemistry, and translational development to deliver therapies for diseases with high unmet medical needs. Our culture prioritizes innovation, scientific rigor, and collaborative problem-solving to accelerate the translation of novel RNA modalities into the clinic.

PositionSummary

The Clinical Trial Manager/Sr Manager/Director will lead the planning, execution, and oversight of clinical trials for a growing biotechnology company developing innovative therapeutics. This is a highly hands‑on leadership role responsible for managing clinical operations, directing CRO partners, ensuring regulatory compliance, and driving operational excellence across all study activities. The ideal candidate thrives in a small, fast‑moving environment and is comfortable building processes while executing in parallel.



Responsibilities 

Clinical Operations Managers are responsible for planning, executing, and managing clinical trials. Their duties include:

• Clinical strategy execution — Translate clinical development plans into operationally feasible study designs, timelines, and budgets. Overseeing daily clinical operations of all clinical studies ensuring smooth workflows and progress as planned, including managing trial timelines.
• CRO oversight — Select, negotiate, and manage CROs and vendors; ensure performance, quality, and adherence to scope.
• Trial operations leadership — Works cross functionally to coordinate all aspects of study conduct including site selection, startup, monitoring, data management, safety reporting, and closeout. Managing clinical trials from start-up to close-out, including protocol design, participant recruitment, monitoring, and data quality assurance.
• Regulatory compliance — Ensure trials comply with GCP, ICH guidelines, FDA regulations, and company SOPs. Inspection readiness — Maintain audit‑ready documentation and lead preparation for regulatory inspections.
• Cross‑functional collaboration — Partner with Clinical Development, Regulatory, CMC, and Finance to align timelines and deliverables.
• Risk management — Identify operational risks early and implement mitigation strategies.
• Implementing process improvements and digital health technologies, such as EHRs and electronic data capture systems, to enhance operational efficiency.
• Budgeting and resource management, including contract negotiations with vendors and site management. Build and manage study budgets.
• Team leadership — Mentor and oversee junior clinical operations staff as the organization grows.
• Position level depends on experience and qualifications
  
  

Qualifications And Skills

• MS, PharmD, or PhD in pharmacology, nursing, biology, or a related field.
• 5-10 years of industrial experience in a biotechnology or pharmaceutical discovery environment. Experience in rare disease and/or pediatric studies strongly preferred
• Extensive experience in leading and managing clinical trials and operations, Site selection, CRO and Vendor management, EDC data review and auditing, budget/invoice reviews, etc.
• Proven track records in supporting development programs, familiar with regulatory guidelines, with demonstrated strength in supporting and steering programs and initiatives through collection of critical data to enable timely decision making.
• Deep understanding of GCP, ICH, and global regulatory expectations.
• Creativity, self-motivation, and an ability to thrive in a fast-paced, multidisciplinary biotech environment with high accountability.
• Experiences in IND/NDA submissions and interactions with regulatory agencies (FDA, EMA, NMPA, TGA, etc) is a plus
• Excellent communication skills, enthusiastic collaborative team builder and leader with strong problem-solving skills.
• Detail oriented with experience in use of excel and other study management tools
• Commitment to innovation and bringing therapies to patients that need them
  
  

What We'll Offer You

• Competitive compensation package including bonus, stock, healthcare insurance, retirement plan, and paid time off time.
• A dynamic early-stage work environment and highly interdisciplinary, talented, and collaborative team.
• Opportunities to invent and discover.