Senior Director, Clinical Operations

Senior Director, Clinical Operations

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

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.

• 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 objectives.
• Regulatory Affairs
  • Provide strategic oversight for regulatory planning and execution.
  • Supervise Regulatory Affairs leadership to support INDs, meeting requests, briefing packages, annual reports, and planning for marketing applications.
  • Collaborate with regulatory authorities and external advisors to advance development programs and maintain compliance.
  • Ensure alignment of development activities with regulatory expectations and corporate objectives.
• Quality Assurance & Compliance
  • Oversee Quality Assurance leadership, company-wide quality systems and compliance processes.
  • Responsible for compliance with GCP, GLP, GMP, ICH guidelines, FDA regulations, and other applicable global regulations.
  • Promote a culture of quality, continuous improvement, and operational excellence.
• Manufacturing, CMC & Supply Chain
  • Responsible for oversight of CMC team, consultants, development, manufacturing operations, supply chain activities, and external CDMO relationships.
  • Ensure timely delivery of clinical supplies and initiate commercial supply planning in accordance with timelines, budgets, and quality requirements.
  • Direct CMC team to support process development, technology transfer, scale-up activities, and manufacturing readiness.
  • Continuously assess and mitigate manufacturing and supply chain risks.
• Program Management
  • In charge of establishing, updating and managing integrated development plans and cross-functional processes.
  • Ensure alignment of clinical, regulatory, quality, nonclinical, and manufacturing activities.
  • Continuously monitor program timelines, contracts, budgets, resource allocation, and critical path activities.
  • Lead program processes and executive portfolio reviews.
• Financial & Business Operations
  • Partner closely with the Chief Financial Officer and Finance team on budgeting, forecasting, and operational expenditures.
  • Support annual planning processes and long-range strategic planning.
  • Establish…