Director Project Management - Rare Disease & Pediatrics- Remote, US

Fortrea•Durham, CA

1d•$160,000 - $180,000•Remote

About The Position

The Director Project Management acts as the primary client lead for complex clinical studies or programs, driving operational delivery across multiple vendors and teams. The role independently oversees highly complex strategies, develops and executes risk-management strategies, resolves escalated project issues, and provides line management and talent development for project management staff. It focuses on operational delivery, improving execution, and using staff effectively. The Director may oversee other Project Managers in a matrix environment and may serve as the primary contact for a strategic client relationship. The role leads project teams in designing, implementing, tracking, and maintaining project plans according to professional standards, SOPs, contracted timelines, and budgets. It is accountable for Trial Master Files (TMFs), including the TMF Index and Plan, audit readiness, and delivery to agreed timelines when contracted by the client. It also leads quality control and risk assurance, supports positive client experiences, contributes to business development and growth objectives, and attracts, develops, and retains high-performing talent.

Requirements

Fluent in English, both written and verbal.
Extensive knowledge of the clinical development spectrum and ICH GCP.
Advanced organizational and time-management skills.
Sound judgment in high-stakes or ambiguous situations.
Exceptional presentation skills for internal and partner audiences at all levels, including executive leadership.
Actively contribute to continuous improvement efforts and strategic planning activities.
University or college degree in life sciences.
At least 9 years of relevant clinical research experience in a pharmaceutical company or CRO, including at least 6 years with full project management responsibility.
At least 4 years of direct or indirect supervisory experience.
A combination of other relevant and equivalent experience may be considered in lieu of the stated experience requirement.

Nice To Haves

Master’s degree preferred.
Experience in rare diseases, neonatal studies, or infant pediatric studies.
PMP certification or certification in clinical research.

Responsibilities

Serve as the primary client contact for assigned clinical studies or programs, independently managing highly complex strategies involving multiple vendors and sub-CROs.
Develop strategies to manage risk and improve operational execution, using staff to maximize contribution and organizational effectiveness.
Contribute to resolving escalated project-level issues.
Oversee line management and talent development for individual contributors and/or managers of project managers.
Build and maintain stakeholder relationships, expand client portfolios, and contribute to growth objectives through training, allocation, and mentorship of experienced team members.
Lead project teams in the design, implementation, tracking, and maintenance of project plans in accordance with professional standards, SOPs, contracted timelines, and budgets.
Manage TMF responsibilities, including the TMF Index and Plan, audit readiness, and delivery to agreed timelines when contracted by the client.
Proactively lead quality control and risk assurance activities to meet regulatory, internal, and client requirements.
Foster positive client experiences through effective communication and collaboration.
Serve as a primary contact for strategic client relationships as needed, and develop and manage relationship-level documents such as charters, MSA negotiations, rate card input, and operations and quality plans.
Initiate process improvements to address variance.
Design delivery strategies for large-scale bid defenses and perform other business development activities.
Attract, select, onboard, develop, and retain high-performing talent; strengthen the talent bench and succession.
Perform other duties as needed or assigned.