[Hiring] Director, Project Management @Everest Clinical Research

Role Description

This leadership role will oversee the project planning, communication, and execution of clinical research and development services offered by Everest. Direct reports include all levels and roles within the Project Management department, including:

• Associate Directors
• Senior Managers
• Managers
• Senior Project Managers
• Project Managers
• Associate Project Managers
• Project Coordinators

In-direct reports/subordinates are those Project Managers who are assigned to the tasks on the client studies and projects overseen by the Director of Project Management (matrixed organization).

Job Accountabilities:

• Plan and implement new client service delivery requests within client portfolio; support evolution of existing client portfolio, providing holistic biometrics and full services (including clinical operations) project deliveries across multiple clinical development programs.
• Strategically align the efforts of functional area directors and managers in project planning, identification of tasks and deliverables, and assessment of resource needs and utilization for existing and new clients/sponsors.
• Perform project and portfolio performance tracking for responsible projects using strategic planning and project tracking methods and tools.
• Conduct regular project progress reviews with internal teams for assigned portfolios, and facilitate conduct of Everest and Client governance meetings to optimize partnership expectations and performance.
• Check and ensure that responsible projects carried out at Everest are properly tracked and managed according to Everest’s quality, operational and financial budget standards.
• Support solution and budget development for complex and unique projects and scope to address client requirements.
• Provide leadership, training, mentorship, and management oversight of project management staff.
• In consultation with the senior Project Management leadership, review new Project Management Applicants and recommend hires for interview processing.
• Further develop and establish policies and Standard Operating Procedures in project management for assurance of quality deliverables.
• Initiate, drive, and support project management departmental process and technology improvement initiatives.
• Lead and contribute to developing reusable project management templates and training materials.
• Identify issues such as lack of planning, lack of resources, poor team performance, or other external factors negatively impacting ongoing projects.
• Interact with clients for strategic partnership governance activities.
• Manage all project management aspects of assigned Phase I -IV clinical trials in accordance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements.
• Lead cross-functional project teams and manage the planning, implementation, conduct, and reporting of assigned projects.
• Proactively track and manage project tasks against timelines and hours spent/budgets.
• Function as senior level facilitator of problem solving and conflict resolution.
• Conduct “lessons learned” meetings with project team members.
• Contribute and/or participate in the performance evaluation of staff who performed under the responsible projects.
• Assist the organization in responding to and preparing for RFI and RFPs.

Qualifications

• B.Sc. or M.Sc. in life sciences or health related field.
• A minimum of 18 years of experience in clinical research and development within a pharmaceutical, biotechnology, institutional, or CRO setting.
• Line management experience required.
• Demonstrated ability to lead and develop others within functional area.
• Demonstrated understanding of cross-functional processes including clinical operations, statistics, data management, pharmacovigilance, subject randomization and drug supply management, data monitoring and adjudication committees, regulatory affairs, and medical writing.
• Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.
• Ability to define scopes and estimate budgets, plan and manage projects, including resource requirements and utilization, hours spent vs. budgets, key deliverables and timelines.
• Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets.
• Excellent interpersonal, oral, and written communication skills.
• Demonstrated strong negotiation and presentation skills.
• Strong ability in problem-solving, including conflict resolution.

Benefits

• Medical, dental, and vision coverage
• Life & AD&D insurance
• Short- and long-term disability
• Tuition reimbursement
• Fitness reimbursement
• Employee assistance program (EAP)
• 401(k) retirement
• Generous paid time off and sick leave
• Opportunity to earn a performance-based bonus