Director, Clinical Research – REMS

• Develop and drive departmental strategy and structure
• Mentor, provide support, and oversee Associate Project Managers and/or Project Managers
• Manage projects as needed
• Work with Managers and Project Directors to ensure projects are adequately staffed, monitor workloads, and adjust as needed
• Assist with Business Development opportunities, RFP review and completion, and bid defense preparation and delivery
• Present UBC capabilities to potential clients at bid defenses
• Work with Business Development to present qualified teams for bid defenses and proposals
• Provide input into proposals and review budgets
• Ensure project deliverables meet contract terms and company quality expectations, including accurate reporting and interpretation of metrics
• Ensure project team members receive adequate training
• Develop and implement department structure and strategies based on staffing and project needs
• Ensure adherence to project plans, company policies, and sponsor SOPs
• Plan and organize project activities with staff
• Resolve operational issues with Managers and project teams
• Report departmental, personnel, and site issues to Senior Management
• Conduct performance appraisals and staff interviews, and assist with CV candidate review
• Maintain working knowledge of active projects and timelines
• Attend team teleconferences, project reviews, client meetings, and finance meetings
• Provide departmental updates to senior management
• Lead cross-functional projects and supervise supporting areas
• Oversee project revenue, invoicing, and financial health
• Develop and grow client relationships and business with UBC leadership and Business Development
• Serve as a resource and mentor to Project Managers and teams
• Identify improvement areas, develop solutions, and execute action plans
• Lead Managers in client and regulatory audits
• Assist in protocol development and patient/subject consent forms or REMS and REMS Supporting Documents
• Supervise multiple Managers and projects, including development in presentations and bid defenses
• Motivate project team members and foster teamwork
• Plan and forecast potential issues, outcomes, and required changes
• Identify and optimize project resources

Requirements

• Advanced Degree preferred
• Bachelor’s degree or equivalent experience required
• Extensive project management experience at a CRO or proven leadership/management experience managing multiple projects and project teams
• Strong knowledge of FDA/ICH regulatory guidelines; only applicable for Europe if required
• Working knowledge of functional components of clinical drug development (e.g., clinical, data management, statistics and regulatory/medical writing)
• Mastery of project management skills with the ability to lead through change and independently lead multiple large projects simultaneously
• Solid problem-solving and analytical skills
• Ability to work in a team environment under high pressure situations
• Excellent interpersonal, written, and verbal communication skills
• Proven ability to interpret and prioritize customer needs
• Strong influencing and negotiation skills
• Initiative and results and detail orientation
• Ability to build strong business relationships across various departments
• Broad therapeutic experience a plus
• 10% travel as required
• Extensive knowledge of Clinical Trial Monitoring, as required
• Clinical background or equivalency in clinical research experience, as required
• Proven knowledge of medical terminology
• European/Global experience a plus
• Advanced computer skills

Core Competencies

Demonstrates extensive project management expertise, including the ability to lead multiple large projects, mentor teams, and ensure adherence to regulatory guidelines. Possesses strong communication, problem-solving, and relationship-building skills essential for successful client interactions and departmental strategy development.

Highest-signal resume keywords

• Project Management Experience
• FDA/ICH Regulatory Knowledge
• Clinical Trial Monitoring
• Interpersonal Communication Skills
• Leadership and Mentoring

Hard Skills

• Project Management
• Clinical Drug Development
• Regulatory Compliance
• Budget Review
• Performance Appraisals
• Problem-Solving
• Analytical Skills
• Proposal Development
• Resource Optimization
• Financial Health Oversight

Soft Skills

• Team Collaboration
• Influencing Skills
• Negotiation Skills
• Detail Orientation
• Initiative

Certifications & Qualifications

• Advanced Degree
• Bachelor’s Degree or Equivalent Experience

Industry Keywords

• CRO
• Clinical Research
• Clinical Trial Monitoring
• Medical Terminology
• Broad Therapeutic Experience
• European/Global Experience

Tools & Technologies

• Advanced Computer Skills