Project Director, BioPharma
Home-Based Anywhere in the United States or Canada
Typically, under the direction of a Director/Senior Director/Executive Director, oversees and directs multiple international projects concurrently. Accountable for project execution to include managing project leaders and teams, developing and managing budgets, timelines, and quality guidelines for projects, thereby ensuring that expectations are met while identifying and mitigating risks. The Project Director is accountable for oversight of project communications, scope, schedule, cost, quality and stakeholders. They ensure that variance from project plans is proactively mitigated and client expectations are met by the team. The Project Director also ensures accurate documentation for the project, with timely data updates that are high quality. They ensure efficient and effective day-to-day operations, while maintaining good relationships with sponsors.
Essential Job Duties:
- Accountable for project execution and serve as key client contact for assigned projects, establishing working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat.
- Lead core project team(s) and facilitate team's ability to lead extended project team(s), ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders.
- Resolve conflict and serve as escalation point for project issues to internal and external stakeholders, as appropriate.
- With key stakeholders, develop the project delivery strategy, costing assumptions and resulting budget for assigned project(s).
- Deliver project(s) to scope, schedule and costs, ensuring all remain on track with the contract and with financial performance targets. Initiate and implement appropriate actions to proactively manage the change control process.
- Proactively lead both quality control and risk assurance activities to ensure project deliverables are met according to regulatory, Labcorp Drug Development, and client requirements.
- Use experience from previous projects and lessons learned to ensure process improvements are implemented successfully across all projects.
- Oversee team management of and variance to required project plans. Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs, managing team performance and adjustments as necessary.
- Develop and manage to key project performance indicators for client specified metrics, ensuring that the KPIs are within scope of the project contract.
- Define and manage project resource needs and establish succession plans.
- In collaboration with relevant departments, prepare and deliver presentations for new business as required.
- University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
- Masters or other advanced degree.
- PMP certification.
- Minimum of 9 years relevant clinical research experience in a pharmaceutical company/CRO, including at least 4 years of full project management responsibility.
- In lieu of the above requirement, candidates with > six years supervisory experience in a health care setting and >seven years clinical research experience including four years of project management experience in the pharmaceutical or CRO industries will be considered
- Experience in managing complex programs with significant financial value and complicated structure, multiple vendors and/or sub-CROs and Academic Research Organizations in a virtual environment.
- Demonstrated ability to handle multiple competing priorities.
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
- Demonstrated ability to lead by example and to encourage team members to seek solutions independently.
- Excellent communication, planning and organizational skills.
- Good computer skills with good working knowledge of a range of computer programs.
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