Project Director, Evidence Development Solutions - RWE BioPharma

Role Description

The Project Director (PD) is responsible for engaging and delivering activities related to project operations, financial performance, business development, and department administration within the UBC Evidence Development Solutions Department.

• Provide operational leadership, oversight, and client relationship management for a broad range of UBC projects.
• Oversee the planning, implementation, direction, and completion of project work.
• Direct Project Managers and cross-functional teams to ensure satisfactory delivery of contracted services within allocated timelines, budgets, and quality standards.
• Support business development opportunities and conduct line management of Project Associates, Associate Project Managers, and Project Managers as required.
• Participate/lead departmental process initiatives.

Qualifications

• Bachelor's degree in an appropriate discipline (Life Sciences, Healthcare, or Business) or equivalent industry experience. Advanced degree (Master's or Ph.D.) preferred.
• Minimum 12 – 15 years of clinical research operations experience within a CRO, pharmaceutical, device/diagnostics, or biotechnology company.
• Minimum 10 years of experience at increasing levels of project management or clinical research oversight responsibilities.
• Previous history as a Project Director or Director of Clinical Operations (related) within a CRO preferred.
• Minimum 5 years supervisory/management experience.
• Proven ability to lead, motivate, and manage cross-functional teams.
• Strong understanding and experience in operational clinical operations and overall drug/biologic development processes.
• Strong knowledge of functional components of clinical drug development (e.g., clinical, data management, statistics, and medical writing).
• Comprehensive knowledge of ICH GCP and applicable international regulations (EU Clinical Trials Directives, FDA Guidelines, etc.).
• Broad therapeutic experience a plus.
• Excellent understanding of and experience managing evidence development projects (e.g., Phase IV studies, RWE, Ph II – III clinical trials, expanded access programs, etc.) globally.
• Ability to drive operational strategy for global evidence development programs.
• Experience with proposal and budget development for evidence development programs.
• Client-focused with strong leadership skills.
• Strong verbal, written, and interpersonal communication skills.
• Strong prioritization, time management, and project management skills.
• Strong negotiation, influencing, consensus building, and relationship management skills.
• Strong innovative, analytical, problem-solving, and decision-making skills.
• Strong financial acumen and budget management experience.
• Strong computer skills including MS Office.
• Proficiency in project management tools and software.
• Results-driven and team-oriented, with the ability to influence outcomes as necessary.
• Demonstrated ability to manage staff to achieve company and client goals.
• Ability to handle multiple tasks in a fast-paced, deadline-oriented environment.
• 10% travel availability.

Requirements

• Provide strategic leadership, vision, and support to the project teams.
• Drive PM performance, project quality delivery, milestone timeline adherence, financial margin optimization, and customer satisfaction.
• Ensure project teams prepare project plans to meet contracted services and timelines.
• Engage in UBC cross-functional interactions to address project needs and drive problem resolution.
• Lead and mentor multidisciplinary project teams.
• Monitor delivery of projects per scope and budgets.
• Proactively identify project risks and develop mitigating strategies.
• Serve as the UBC senior operational contact with clients for all project-related items.
• Implement quality control measures to maintain high standards of data integrity, patient safety, and protocol compliance.
• Prepare, maintain, and deliver high-quality project progress reports, metrics, and other outputs to clients and UBC senior management.
• Assist on specific business development opportunities.
• Responsible for the development, implementation, and project management process compliance for global projects.
• Manage the process of identifying/tracking staffing requirements.
• Ensure timely completion of timesheets and expense reporting by assigned staff.

Benefits

• Competitive salaries
• Growth opportunities for promotion
• 401K with company match*
• Tuition reimbursement
• 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
• Adoption assistance
• Short term disability
• Long term disability
• Life insurance
• Discount programs