Director, Clinical Operations

Position Overview

The Director, Clinical Operations is the senior leader accountable for the strategic and operational delivery of Peptilogics’ clinical programs. This role oversees all aspects of clinical trial planning, execution, and reporting, ensuring studies are delivered on time, within budget, and in compliance with applicable regulations and GCP standards. The Director provides functional leadership, including resource planning, hiring, performance management, and budget oversight, while serving as the primary point of contact for clinical operations internally and externally. As a key member of the leadership team, this individual drives operational excellence, represents Clinical Operations in strategic planning forums, and ensures seamless cross-functional collaboration to advance Peptilogics’ development programs from early to late stage.

Essential Functions

• Provide functional line management, including performance reviews, development planning, and team resource allocation
• Serve as the primary point of contact and lead for the operational management of all clinical trial programs
• Oversee the planning, execution, and completion of clinical trial activities and deliverables within scope, budget, and timelines

Additional Duties and Responsibilities

• Ensure all clinical programs comply with applicable regulations, guidelines, and GCP requirements
• Manage and oversee clinical trials executed through CROs and other vendors
• Prepare and maintain internal and external clinical trial program documentation and reporting
• Track and report on key performance indicators (e.g., protocol finalization, CRO contracting, patient enrollment milestones, data lock, report finalization)
• Contribute to clinical development program planning, including scenario modeling, feasibility assessments, budget forecasting, and operational strategy development
• Attend relevant scientific conferences to represent Peptilogics, including identifying and engaging potential investigators and trial sites
• Represent Clinical Operations to the Leadership Team and Board of Directors, as requested
• Perform other duties as assigned

Required Qualifications and Skills

• BA/BS degree in related field
• RN/PA with professional clinical experience, and/or master’s degree or higher in health-related science or equivalent preferred
• Documentation of GCP training and certification preferredBachelor’s or advanced degree in microbiology, pharmacology, toxicology, or a related field
• 10+ years of progressive Clinical Operations experience with increasing leadership responsibilities
• Proven success managing domestic and international Phase 1–4 clinical trials via CROs and direct oversight
• Demonstrated leadership in cross-functional and matrixed environments
• Strong track record in project management of complex clinical programs
• Excellent interpersonal skills, integrity, and professionalism
• Ability to operate effectively in a fast-paced, dynamic environment with shifting priorities
• Exceptional leadership, communication, operational, and organizational skills
• Decision-making capability in the face of incomplete information or evolving guidance
• Self-directed with a strong focus on both short- and long-term objectives
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint)
• Familiarity with GCP training and certification preferred
• Startup company clinical trial leadership experience preferred
• RN/PA with professional clinical background and/or advanced degree in health-related science preferred