Senior Director, Clinical Operations

Senior Director, Clinical Operations Skip to main content

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Boston-Remote time type:
Full time posted on:
Posted Todayjob requisition :
JR000603
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Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.
** Job Description Summary
**** Job Description
** The Senior Director, Clinical Operations, is a key member of the Executive Leadership Team responsible for the strategic and operational leadership of the Company's clinical development operations. The Senior Director, Clinical Operations provides oversight of Clinical Development Operations, Nonclinical Development, Regulatory Affairs, Quality Assurance, Manufacturing/CMC Operations, and Program Management, while partnering closely with R&D, Finance, Investor Relations, Legal, and the CEO to ensure efficient execution of corporate objectives.

This role is accountable for translating the clinical operations strategy into operational execution, driving cross-functional alignment, ensuring compliance with global regulatory requirements, maintaining operational excellence, and supporting the advancement of the Company's development pipeline from research through commercialization.  The ideal candidate will possess biotech or pharmaceutical industry background, demonstrated leadership across multiple clinical operations disciplines, and some experience in building and scaling clinical operations organizations in a fast-paced, dynamic environment.

KEY RESPONSIBILITIES:

Corporate Leadership & Strategic Operations  
• Serve as a member of the Executive Leadership Team and participate in corporate strategy development.  
• Lead day-to-day company clinical operations to ensure implementation and execution of strategic, development, and commercial objectives.  
• Drive clinical operations organizational effectiveness, cross-functional communication, and execution accountability.  
• Develop clinical operational plans to support corporate growth, financing activities, partnerships, and strategic initiatives.  
• Identify clinical operational risks and implement mitigation strategies.

Clinical Development Operations  
• In charge of executive oversight of clinical operations activities across all development programs.  
• In charge of efficient execution of clinical trials, including site activation, enrollment, monitoring, data management, safety reporting, and vendor oversight. The main focus is on the Phase 2a timely execution and progress according to established timelines.  
• Partner with Medical Development leadership to ensure achievement of program milestones and timelines.  
• Ensure adherence to GCP and applicable regulatory requirements.  Nonclinical Development  
• Oversee non-clinical development vendors, consultants, activities, including pharmacology, toxicology, bioanalytical projects.  
• Ensure nonclinical studies are executed in accordance with GLP requirements and development objectives.  
• Coordinate nonclinical strategy with clinical, regulatory, and CMC functions to support development…