Director, Clinical Research - REMS

Brief Description

Develop and drive departmental strategy and structure, mentor, provide support, and oversee Associate Project Managers and/or Project Managers.

Specific Job Duties

• Manage projects as needed
• Work with Managers and Project Directors to ensure projects are adequately staffed; monitor workloads and adjust as needed
• Assist with specific project opportunities in Business Development, RFP review and completion, and bid defense preparation and delivery
• Present UBC capabilities to potential clients at bid defenses
• Work with Business Development to ensure presentation of a qualified team for bid defense and proposals
• Provide input into proposals and review budgets
• Ensure performance of project deliverables according to contract terms and company quality expectations, including accurate reporting and interpretation of metrics
• Ensure project team members receive adequate training for specific job assignments
• Develop and implement department structure and strategies based on current staffing and project needs
• Ensure adherence to project plans, company policies and/or sponsor's SOPs
• Work with staff to plan and organize project activities
• Ensure teams have consistency with completion of job-related tasks
• Work closely with Managers and project teams to resolve operational issues
• Report and discuss departmental, personnel and/or site issues with Senior Management
• Conduct performance appraisals if assigned direct reports
• Conduct staff interviews; assist with CV candidate review
• Maintain working knowledge of all active projects and timelines
• Attend applicable team teleconferences/meetings as well as project reviews
• Attend face-to-face client meetings and provide support
• Attend finance meetings and perform necessary follow-up to resolution
• Provide departmental updates to senior management
• Lead projects with cross-functional involvement and supervise all areas that support the project
• Oversee all project revenue and invoicing with strong understanding of project financial health
• Work with UBC's leadership and Business Development to develop and grow client relationships and business
• Proactively serve as a resource and mentor to Project Managers and teams for problem resolution
• Proactively identify areas of improvement, provide solutions and execute plans of action
• Lead Managers in client/regulatory audits
• Assist in protocol development and/or patient/subject consent form or REMS and REMS Supporting Documents
• Other duties as assigned by management

Supervisory Responsibility

Direct project supervision of multiple Managers, including development of Managers in presentation and bid defenses, proposal and implementation of action plans, and ensuring Managers have a clear understanding of client needs once a project is awarded. Responsible for direct reports in addition to supervision of multiple Managers and projects as assigned.

• Serve as a resource and mentor to the Managers in their daily activities
• Proactively assist the Managers in anticipating and seeking resolutions to potential and actual project issues
• Motivate project team members by fostering teamwork
• Maintain positive attitude
• Ability to plan and forecast potential issues, outcomes, and changes necessary to ensure program and developmental success
• Ability to identify and optimize resources

Desired Skills and Qualifications

• 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
• 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 with willingness and ability to detect process gaps, challenge assumptions, and drive change and improvement
• 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
• Takes initiative and is results and detail oriented
• 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