Senior Project Director, Evidence Development Solutions – Oncology

• Provide strategic leadership, vision, and support to the project teams, ensuring alignment with the company's goals and client expectations.
• Drive PM performance, project quality delivery, milestone timeline adherence, financial margin optimization, and customer satisfaction through efficient and effective directorship.
• 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 the involvement of Senior Management as necessary.
• Attend/participate in project internal / external meetings, and audits as needed
• Lead and mentor multidisciplinary project teams, including Project Managers, Operations teams, vendors, and other functional staff, ensuring effective communication, collaboration, and performance of project deliverables according to contract terms.
• Work with cross‑functional managers to ensure projects are adequately staffed team members receive adequate training for specific job assignments.
• Select, contract, and manage external vendors and subcontractors, when necessary, while maintaining quality and cost‑effectiveness.
• Monitor delivery of projects per scope and budgets, and demonstrate strong oversight of the financial health for assigned projects.
• Oversee project budgets, resource expenditures, and effectively drive compliance with forecasting, invoicing, revenue recognition, out‑of‑scope management, and contract modifications.
• Proactive, ongoing identification of project risks and development of mitigating strategies to minimize their impact on projects effectively.
• Ensure development and maintenance of risk management plans and risk assessments and categorization tools.
• Serve as the UBC senior operational contact with clients for all project related items, maintaining strong relationships, addressing their needs, and providing regular project updates.
• Ensure regular conduct of formal governance discussions to assess performance and drive issue resolution.
• Implement quality control measures to maintain the highest standards of data integrity, patient safety, and protocol compliance.
• Ensure activities on projects are delivered with adherence to project Plans, company policies and/or sponsor’s SOPs.
• Be familiar with and ensure that all projects adhere to relevant regulatory requirements, data privacy provisions, and international guidelines (e. g., FDA, EMA, EU Clinical Trials Directives, ICH-GCP, GDPR, HIPAA).
• Prepare, maintain, and deliver high quality project progress reports, metrics, and other outputs to clients and UBC senior management.
• Ensure that project specific tracking metrics are developed, consistent with scope of work and project timelines.
• Ongoing review of available dashboards and reports for assigned projects to ensure adherence to all required activities and operational / financial performance indicators.
• Lead and drive specific business development opportunities: capabilities presentations, RFP review, proposals/budget input, bid defence participation.
• Work with UBC Business Development to develop and grow UBC client relationships and maximum business opportunities.
• Attend and present at conferences as required.
• Responsible for the development, implementation, and project management process compliance for global projects.
• Lead, innovate, and develop operational strategies that meet requirements and 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 staff to optimize project delivery.
• Contribute to UBC meetings, training activities, and cross‑functional activities as appropriate.
• Responsible for leading ongoing assessment of project delivery resource needs, including management of resource requests and oversight of department allocations aligned to utilization targets.
• Implement creative resourcing solutions to maximize productivity and utilization of the team.
• Manage the process of identifying/tracking staffing requirements and liaise with Human Resources regarding strategy, hiring, and onboarding project management resources.
• Identify and develop UBC process improvements.
• Prepare procedures, SOPs, guidelines and other standard materials for department.
• Ensure staff are adequately trained on applicable SOPs, processes, and systems.
• Ensure timely completion of timesheets and expense reporting by assigned staff.
• Ensure timely completion of required UBC and project specific training by assigned staff.
• Other duties as assigned by UBC Senior Leadership.
• Expected Project Load: PD Oversight of 6 to 8 projects, depending on scope.
• PD Oversight of up to 2 multi-study programs, depending on scope.
• Mentor, provide support, and direct supervision of Project Managers, Associate Project Managers, Project Associates, and other administrative staff.
• Conduct interviews for internal/external project management and operational candidates.
• Conduct ongoing performance review of assigned staff and remediate deficiencies.
• Conduct annual employee performance evaluations.

Requirements

• Bachelor's degree in in an appropriate discipline (Life Sciences, Healthcare, or Business) or equivalent industry experience.
• Advanced degree (Master's or Ph. D.) preferred.
• Minimum 15-20 years of clinical research operations experience, within in a CRO, pharmaceutical, device/diagnostics or biotechnology company
• Minimum 15 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 8 years supervisory/management experience
• Proven ability to lead, motivate, and manage cross‑functional teams.
• Deep 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
• Proven understanding of methodological, scientific, and operational aspects related to the planning and execution of evidence development and RWE programs (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 in pricing/proposal models for evidence development programs and application to staffing requirements.
• Client focused with enhanced leadership skills
• Excellent verbal, written, and interpersonal communication skills
• Excellent prioritization, time management, and project management skills
• Excellent negotiation, influencing, consensus building, and relationship management skills
• Excellent innovative, analytical, problem-solving and decision-making skills
• Excellent financial acumen and budget management experience.
• Excellent 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
• Core Competencies

Demonstrates extensive experience in clinical research operations and project management, with a strong focus on leading cross‑functional teams and ensuring compliance with regulatory standards.

Proven ability to drive operational strategies and optimize project delivery while maintaining financial oversight and client relationships.

• Highest-signal resume keywords
• Clinical Research Operations Experience
• Project Management Leadership
• Regulatory Compliance Knowledge
• Budget Management Expertise
• Cross-Functional Team Management
• ATS Optimization Keywords
• Hard Skills
• Project Management
• Clinical Drug Development
• Risk Management
• Financial Acumen
• Data Management
• Statistical Analysis
• Medical Writing
• Evidence Development Programs
• Proposal Development
• Resource Allocation
• Soft Skills
• Leadership
• Communication
• Problem‑Solving
• Negotiation
• Time Management
• Industry Keywords
• CRO
• FDA Guidelines
• ICH GCP
• EU Clinical Trials Directives
• Biotechnology
• Pharmaceutical
• Device/Diagnostics
• Clinical Trials
• RWE Programs
• Phase IV Studies
• Tools & Technologies
• MS Office
• Project Management Software
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