Director, Clinical Research REMS

About the role

UBC is a leader in the pharmaceutical support industry, dedicated to enhancing patient outcomes and advancing healthcare through drug development and commercialization.

Responsibilities

• 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, as directed, 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
• 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
• 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 updates 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 plans 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
• 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
• Supervise multiple Managers and projects as assigned, if assigned direct reports
• 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, inclusive of knowing when to identify and/or assign additional/or different resources

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 (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
• 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

Skills

• 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 (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
• 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

Benefits

• Remote opportunities
• Competitive salaries
• Growth opportunities for promotion
• 401K with company match
• Tuition reimbursement (after 90 days of employment)
• Flexible work environment
• Discretionary PTO (Paid Time Off)
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and vision coverage
• HSA/FSA
• Telemedicine (Virtual doctor appointments)
• Wellness program
• Affordability assistance
• Adoption assistance
• Short-term disability (after 90 days of employment)
• Long-term disability
• Life insurance
• Discount programs