Director, Clinical Research - REMS Project Management

UBC is a pharmaceutical support industry leader dedicated to empowering health solutions and improving patient outcomes. The Director of Clinical Research - REMS Project Management will manage projects, ensure adequate staffing, and oversee project deliverables while fostering client relationships and mentoring managers.

Responsibilities:

• Manage projects as needed
• Work with Managers and Project Directors to ensure projects are adequately staffed; monitor workloads and adjust as needed
• Assist, as directed, 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 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 (as needed) 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, as needed, for possible resolutions
• Conduct performance appraisals if assigned direct reports
• Conduct staff interviews; assist with CV candidate review
• 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, as needed
• Attend finance meetings and perform necessary follow-up to resolution
• Provide departmental update to senior management, as requested
• 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 to maximum potential
• Proactively serve as a resource and mentor to Project Managers and teams for problem resolution; facilitate the involvement of Senior Management as necessary
• Proactively identify areas of improvement, provide solutions and execute plan of action to address
• Lead Managers in client/regulatory audits, as required
• Assist in protocol development and/or patient/subject consent form or REMS and REMS Supporting Documents, as required
• Other duties as assigned by management

Requirements:

• 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 (additional or other relevant management experience may be considered)
• 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 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
• 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
• Advanced computer skills
• Advanced Degree preferred
• Broad therapeutic experience a plus
• European/Global experience a plus