Senior Project Director, Evidence Development Solutions – Oncology

🕒 Julho 7

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UBC

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2003

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

Healthcare • Consulting • Biotechnology

A UBC é uma empresa dedicada a melhorar os resultados dos pacientes, conectando terapias especializadas aos pacientes que delas necessitam. Eles oferecem soluções modernas e personalizadas, focando em acesso, segurança e geração de evidências para produtos biofarmacêuticos. A UBC é especializada em desenvolvimento de evidências, gestão de riscos e acesso do paciente, utilizando dados do mundo real e tecnologias inovadoras para otimizar a jornada de saúde e garantir o uso eficaz de medicamentos.

Descrição

• 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 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.

🎯 Requisitos

• 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

🏖️ Benefícios

• Remote opportunities • Competitive salaries • Growth opportunities for promotion • 401K with company match • Tuition reimbursement (after 90 days of employment) • 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 (after 90 days of employment) • Long-term disability • Life insurance • Discount programs