Sr. Project Director, Evidence Development Solutions

United Biosource Corporation• Remote, US,

9d•Remote

About The Position

As leaders in the pharmaceutical support industry, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC, we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation. Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values of Respect, Accountability, Innovation, Quality, Integrity, and Collaboration. We believe in an inclusive workplace that fosters creativity. If you are seeking a career that will challenge, inspire, and reward you, join us at UBC! NOTE: This position is seeking experience with Oncology and Neurology indications. Brief Description: The Sr. Project Director (PD) is responsible for engaging and delivering activities related to project operations, financial performance, business development, and department administration within the UBC Evidence Development Solutions Department. The Sr. PD is responsible for providing senior operational leadership, oversight, and client relationship management for a broad range of UBC projects and programs. The Sr. PD will have a leading role in overseeing the planning, implementation, direction, and completion of project work. The Sr. PD will be responsible for directing Project Managers and cross-functional teams to ensure satisfactory delivery of contracted services within the allocated timelines, budgets, and quality standards. Additionally, the Sr. PD will lead and direct business development opportunities, conduct line management of Project Associates, Associate Project Managers, Project Managers, Associate Project Directors as required, and participate/lead departmental process initiatives.

Requirements

Bachelor's degree in in an appropriate discipline (Life Sciences, Healthcare, or Business) or equivalent industry experience.
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
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.)
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

Nice To Haves

Advanced degree (Master's or Ph.D.) preferred.
Previous history as a Project Director or Director of Clinical Operations (related) within a CRO preferred
Broad therapeutic experience a plus
Experience with Oncology and Neurology indications.

Responsibilities

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
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