Project Director, Evidence Development - RWE/Phases II-IV

About the role

This fully remote position is within the UBC Evidence Development Solutions Department. The Project Director (PD) is responsible for engaging and delivering activities related to project operations, financial performance, business development, and department administration. This role requires experience managing evidence development projects (e.g., Phase II-IV studies, RWE, expanded access programs, etc.) globally.

The PD provides operational leadership, oversight, and client relationship management for a broad range of UBC projects, overseeing planning, implementation, direction, and completion of project work. The PD directs Project Managers and cross-functional teams to ensure satisfactory delivery of contracted services within allocated timelines, budgets, and quality standards. Additionally, the PD supports business development opportunities, conducts line management of Project Associates, Associate Project Managers, and Project Managers, and participates in or leads departmental process initiatives.

Responsibilities

• Project Leadership:
  • Provide strategic leadership, vision, and support to project teams, ensuring alignment with company goals and client expectations.
  • Drive Project Manager 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; facilitate Senior Management involvement as necessary.
  • Attend and participate in project internal/external meetings and audits as needed.
• Project Team Productivity:
  • Lead and mentor multidisciplinary project teams, including Project Managers, Operations teams, vendors, and other functional staff.
  • Ensure effective communication, collaboration, and performance of project deliverables according to contract terms.
  • Work with cross-functional managers to ensure projects are adequately staffed and team members receive training for specific job assignments.
• Vendor Management: Select, contract, and manage external vendors and subcontractors while maintaining quality and cost-effectiveness.
• Financial Oversight:
  • Monitor delivery of projects per scope and budgets, demonstrating strong oversight of financial health for assigned projects.
  • Oversee project budgets, resource expenditures, and drive compliance with forecasting, invoicing, revenue recognition, out-of-scope management, and contract modifications.
• Risk Management:
  • Proactively identify project risks and develop mitigating strategies to minimize their impact.
  • Ensure development and maintenance of risk management plans and risk assessment tools.
• Client Relationship Management:
  • Serve as the UBC senior operational contact with clients for all project-related items, maintaining strong relationships and addressing their needs.
  • Provide regular project updates and conduct formal governance discussions to assess performance and drive issue resolution.
• Quality Compliance Oversight:
  • Implement quality control measures to maintain the highest standards of data integrity, patient safety, and protocol compliance.
  • Ensure project activities adhere to project plans, company policies, and/or sponsor’s SOPs.
  • Ensure projects adhere to relevant regulatory requirements, data privacy provisions, and international guidelines (e.g., FDA, EMA, EU Clinical Trials Directives, ICH-GCP, GDPR, HIPAA).
• Reporting:
  • Prepare, maintain, and deliver high-quality project progress reports, metrics, and other outputs to clients and UBC senior management.
  • Ensure project-specific tracking metrics are developed, consistent with scope of work and project timelines.
  • Conduct ongoing reviews of available dashboards and reports for assigned projects to ensure adherence to operational and financial performance indicators.
• Business Development:
  • Assist with business development opportunities, including capabilities presentations, RFP review, proposals/budget input, and bid defense participation.
  • Work with UBC Business Development to grow client relationships and maximize business opportunities.
  • Attend and present at conferences as required.
• Department Administration:
  • Develop, implement, and ensure compliance with project management processes for global projects.
  • Lead, innovate, and develop operational strategies to maximize project delivery success.
  • Identify, develop, and implement improvements to UBC processes, quality, and overall project delivery.
  • Engage in cross-functional collaborations with UBC leadership to optimize project delivery.
  • Contribute to UBC meetings, training activities, and cross-functional initiatives.
  • Assess project delivery resource needs, manage resource requests, and allocate staff to maintain target utilizations.
  • Implement creative resourcing solutions to maximize productivity and utilization of the team.
  • Manage the process of identifying and tracking staffing requirements; liaise with Human Resources regarding strategy, hiring, and onboarding.
  • Identify and develop UBC process improvements.
  • Prepare procedures, SOPs, guidelines, and other standard materials for the department.
  • Ensure staff are adequately trained on applicable SOPs, processes, and systems.
  • Ensure timely completion of timesheets, expense reporting, and required UBC/project-specific training by assigned staff.
• Supervisory Responsibility:
  • Mentor, support, and directly supervise Project Managers, Associate Project Managers, Project Associates, and other administrative staff.
  • Conduct interviews for internal/external project management and operational candidates.
  • Conduct ongoing performance reviews of assigned staff and remediate deficiencies.
  • Conduct annual employee performance evaluations.

Expected Project Load: PD oversight of 4 to 6 projects (depending on scope), oversight of 1 multi-study program (depending on scope), and direct management of 1 to 2 projects (depending on scope).

Requirements

• Bachelor's degree in Life Sciences, Healthcare, 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 of 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 (e.g., EU Clinical Trials Directives, FDA Guidelines).
• Broad therapeutic experience is a plus.
• Excellent understanding and experience managing evidence development projects (e.g., Phase IV studies, RWE, Phase II–III clinical trials, expanded access programs) globally.
• Ability to drive operational strategy for global evidence development programs.
• Experience with proposal and budget development for evidence development programs.
• Strong leadership skills with a client-focused approach.
• 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 and 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.

Benefits

• Competitive salaries.
• Growth opportunities for promotion.
• 401K with company match.
• Tuition reimbursement.
• Flexible work environment.
• Discretionary Paid Time Off (PTO).
• Paid holidays.
• Employee assistance programs.
• Medical, dental, and vision coverage.
• HSA/FSA.
• Telemedicine (virtual doctor appointments).
• Wellness program.
• Adoption assistance.
• Short-term and long-term disability.
• Life insurance.
• Discount programs.