Senior Project Director, Evidence Development Solutions – Oncology

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic guidance, vision, and support to project teams, ensuring alignment with the organization's objectives and client expectations.

• Enhance PM performance, project quality delivery, adherence to milestone timelines, optimization of financial margins, and customer satisfaction through effective leadership.

• Ensure project teams develop project plans that align with contracted services and timelines.

• Engage in cross-functional interactions within UBC to address project needs and facilitate problem resolution; involve Senior Management as required.

• Attend and participate in internal/external project meetings and audits as necessary.

• 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 in accordance with contract terms.

• Collaborate with cross-functional managers to ensure adequate staffing and training for team members assigned to specific roles.

• Select, contract, and oversee external vendors and subcontractors when necessary, ensuring quality and cost-effectiveness.

• Monitor project delivery according to scope and budget, demonstrating strong oversight of financial health for assigned projects.

• Oversee project budgets, resource expenditures, and ensure compliance with forecasting, invoicing, revenue recognition, out-of-scope management, and contract modifications.

• Proactively identify project risks and develop strategies to mitigate their impact effectively.

• Ensure the development and maintenance of risk management plans and risk assessments, along with categorization tools.

• Serve as the senior operational contact at UBC for clients on all project-related matters, nurturing strong relationships, addressing their needs, and providing regular project updates.

• Conduct formal governance discussions regularly to assess performance and facilitate issue resolution.

• Implement quality control measures to uphold the highest standards of data integrity, patient safety, and protocol compliance.

• Ensure project activities are conducted in adherence to project plans, company policies, and/or sponsor’s SOPs.

• Familiarize and ensure compliance with all 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 in accordance with the scope of work and project timelines.

• Continuously review available dashboards and reports for assigned projects to ensure compliance with all required activities and operational/financial performance indicators.

• Lead and drive specific business development opportunities: capabilities presentations, RFP reviews, proposals/budget inputs, and bid defense participation.

• Collaborate with UBC Business Development to cultivate and expand client relationships and maximize business opportunities.

• Attend and present at conferences as required.

• Responsible for the development, implementation, and compliance of project management processes for global projects.

• Lead, innovate, and formulate operational strategies that meet requirements and maximize project delivery success.

• Identify, develop, and implement enhancements to UBC processes, quality, and overall project delivery.

• Engage in collaborative efforts with UBC leadership to optimize project delivery.

• Contribute to UBC meetings, training sessions, and cross-functional activities as appropriate.

• Oversee ongoing assessments of project delivery resource needs, managing resource requests and department allocations aligned to utilization targets.

• Implement innovative resourcing solutions to maximize team productivity and utilization.

• Manage the identification and tracking of staffing needs and liaise with Human Resources regarding strategy, hiring, and onboarding of project management resources.

• Identify and develop improvements to UBC processes.

• Prepare procedures, SOPs, guidelines, and other standard materials for the department.

• Ensure staff are adequately trained on relevant SOPs, processes, and systems.

• Ensure timely completion of timesheets and expense reports by assigned staff.

• Ensure timely completion of necessary UBC and project-specific training by assigned staff.

• Perform 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, support, and supervise Project Managers, Associate Project Managers, Project Associates, and other administrative staff.

• Conduct interviews for internal and external project management and operational candidates.

• Conduct ongoing performance reviews of assigned staff and address deficiencies.

• Conduct annual employee performance evaluations.

⛳️ Requirements

• Bachelor's degree in a relevant field (Life Sciences, Healthcare, or Business) or equivalent industry experience.

• Advanced degree (Master's or Ph.D.) is preferred.

• Minimum of 15-20 years of experience in clinical research operations, within a CRO, pharmaceutical, device/diagnostics, or biotechnology company.

• At least 15 years of experience at increasing levels of project management or clinical research oversight responsibilities.

• Prior experience as a Project Director or Director of Clinical Operations (related) within a CRO is preferred.

• Minimum of 8 years of supervisory or management experience.

• Proven ability to lead, motivate, and manage cross-functional teams.

• In-depth 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 is 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, Phase 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 their application to staffing requirements.

• Client-focused with enhanced leadership skills.

• Excellent verbal, written, and interpersonal communication abilities.

• Strong prioritization, time management, and project management skills.

• Excellent negotiation, influencing, consensus-building, and relationship management skills.

• Exceptional innovative, analytical, problem-solving, and decision-making capabilities.

• Strong financial acumen and experience in budget management.

• Proficient in computer skills, including MS Office.

• Proficiency in project management tools and software.

• Results-oriented and team-focused, with the ability to influence outcomes as needed.

• Demonstrated ability to manage staff to achieve company and client objectives.

• Ability to handle multiple tasks in a fast-paced, deadline-driven environment.

• Availability for 10% travel.

🏝️ Benefits

• Remote opportunities available.

• Competitive salary packages.

• Opportunities for career advancement.

• 401K plan with company matching.

• Tuition reimbursement available after 90 days of employment.

• Flexible work environment.

• Discretionary Paid Time Off (PTO).

• Paid holidays.

• Employee assistance programs.

• Medical, Dental, and Vision coverage.

• Health Savings Account (HSA) and Flexible Spending Account (FSA).

• Telemedicine services (virtual doctor appointments).

• Wellness program offerings.

• Adoption assistance programs.

• Short-term disability benefits available after 90 days of employment.

• Long-term disability coverage.

• Life insurance options.

• Access to discount programs.