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