The Head of Clinical Operations will oversee the Clinical Operations team at Attralus. The Head is accountable for the work product for the program(s), and responsible for the overall planning and implementation of clinical development studies including scenario planning, high level forecasting of timelines, assessment program level feasibility, estimation of resources and budget, and development of high-level operational strategies. The Head is responsible for operational management, including documentation and reporting requirements of the clinical development studies and program(s) and reports to the Chief Medical Officer.

Essential Duties and Responsibilities:

  • Accountable for the oversight and successful, on-time execution of clinical trials conducted by Attralus 
  • With Biometrics, participates in the selection of Contract Research Organizations (CROs) supporting clinical studies 
  • Develop and maintain strong relationships with vendors to ensure effective execution of clinical trials 
  • Accountable for continued process improvement and ongoing ICH/GCP maintenance 
  • Collaborate within the department and other key functions both internally and externally to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget 
  • Contribute to the strategy, planning and implementation of clinical development programs including scenario planning, forecasting enrollment and timelines, assessment program level feasibility, estimation of resources and budget, and development of operational strategies 
  • Contribute to developing department processes and SOPs to ensure adherence to Attalus standards, and all applicable regulations and guidelines 
  • Recruit, train, manage, mentor and develop talent to support and lead clinical operations and development programs. Represent Clinical Operations (or delegate representation) on appropriate cross-functional teams 
  • Accountable for the development and maintenance of the necessary resource and budget forecasting for Clinical Operations 
  • Contribute to and facilitate the development of standard clinical trial management plans and tools 
  • Contribute to and facilitates Clinical Operations' GCP compliance activities, reporting, and inspection readiness systems and activities 
  • Oversee clinical site and sponsor GCP inspection preparation and support activities 
  • Oversee study timelines and budget(s); review/approve study-related invoices 
  • All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs

Qualifications:

  • Bachelor’s degree required. RN/PA with professional clinical experience, and/or master’s degree or higher in health-related science or equivalent preferred 
  • At least 15 years of relevant experience and at least 7 years managing a team 
  • Experience developing and coaching direct reports and assessing talent and areas of opportunity • Outstanding organizational and time management skills; proven abilities to manage multiple, often complex and sometimes competing, objectives, goals and other priorities to effective and efficient conclusion 
  • Proven ability to effectively work in a cross-functional/matrix environment and successfully leverage internal and external partnerships 
  • Outstanding judgment and decision-making skills; past results are indicative of consistently sound and effective business decisions 
  • Strong interpersonal, influencing, presentation, and written and verbal communications skills; able to effectively address all levels within an organization



This position has been filled.