Senior Director of Clinical Projects, Clinical Assessment Technologies

Responsibilities

• Engage with senior management to establish strategic departmental initiatives and objectives
• Accountable for clinical team key performance indicators (KPIs) and associated metrics
• Drive identification of process improvement needs and coordinate initiatives to support these activities
• Create and lead CAT committees to further initiatives
• Actively participate in the identification and development of new service arms
• Actively participate in the improvement of existing service arms
• Drive business development activities for CAT, including proposal input, participation in capabilities presentations, and bid defense activities
• Participate in internal and external marketing activities
• Serve as an external spokesperson for CAT
• Oversee, train, and support the clinical team
• Actively engage in the protocol development process, including research, literature review, assessment review, and risk assessment
• Identify clinical needs for upcoming and current projects, and track and review them with CAT Clinical Staff and Leadership
• Resource CAT study projects as Resource Manager
• Accountable for all contracted clinical activities in clinical trials
• Provide clinical expertise and review of clinical plans and training content for CAT-awarded trials
• Create and lead CAT committees to further initiatives
• Actively participate in the identification and development of new service arms
• Collaborate with CAT staff, Project Management, and Contracts on study budget development, including Work Orders, Letters of Intent, Change Orders, and Change Notification Forms
• Drive research activities, including data analysis, white papers, posters, and related contributions
• Apply advanced knowledge of industry regulations, GCP, and ICH guidelines to ensure full operational and clinical compliance during clinical trial conduct
• Perform other duties as assigned.

Requirements

• Master’s degree in life sciences or equivalent
• At least 10 years of clinical trial experience with clinical assessments, including independently organizing and conducting projects and presenting at Investigators’ Meetings or similar forums as an expert clinician
• Preferred minimum of 4 years of experience managing team members or providing direct clinical mentorship
• Strong applied knowledge of pivotal efficacy measure administration conventions and the ability to train assessors
• Knowledge of operational aspects of Phase I–IV clinical research trials and experience working with a Contract Research Organization or Rater Training Organization
• Excellent collaboration skills and ability to work cross-functionally to drive projects and initiatives
• Strong problem-solving and critical thinking skills
• Demonstrated ability to apply knowledge and utilize resources to develop new ideas and improve existing processes
• Excellent knowledge of SOPs, ICH/GCP, and regulatory guidelines
• Competence in working with data and numerical analysis
• Fluency in English, including reading, writing, and speaking, for daily business operations