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

Fortrea•Durham, NC

4d•Remote

About The Position

The Director Project Management serves as the primary client lead for complex clinical studies or programs, driving operational delivery across multiple vendors, sub-CROs, and teams. The role independently leads highly complex programs, develops and executes risk-management strategies, resolves escalated project issues, and may provide program-level oversight to other project managers in a matrix environment. With a focus on operational delivery, the Director develops strategies to manage risk and improve execution; leads project teams in designing, implementing, tracking, and maintaining project plans; and ensures work follows professional standards and SOPs within contracted timelines and budgets. The role is accountable for Trial Master Files (TMFs), including the TMF Index and Plan, audit readiness, and timely delivery when contracted by the client. It also proactively leads quality-control and risk-assurance activities to satisfy regulatory, internal, and client requirements. The position builds and maintains relationships with stakeholders and clients, may serve as the primary contact for strategic client relationships, and develops or manages relationship documents such as charters, master service agreements, rate-card input, and operations and quality plans. The Director contributes to portfolio expansion and business growth, leads delivery strategy for large-scale bid defenses, initiates process improvements, and provides line management, talent development, mentorship, and succession planning for project management staff.

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, including executive leadership.
Active contribution 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 place of the stated experience requirement.

Nice To Haves

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

Responsibilities

Serve as the primary client contact for assigned clinical studies or programs, independently leading complex strategies involving multiple vendors and sub-CROs.
Provide program-level oversight to project managers working in a matrix environment, as applicable.
Develop strategies to manage risk and control or improve operational execution.
Use staff effectively 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 strong relationships with stakeholders at all levels of the business and contribute to client portfolio growth.
Lead project teams in the design, implementation, tracking, and maintenance of project plans in accordance with professional standards, SOPs, contracted timelines, and budgets.
Oversee TMFs, including the TMF Index and Plan, audit readiness, and delivery according to agreed timelines when contracted by the client.
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 applicable.
Develop and manage strategic relationship documents, including 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.