Director, Project Management – Rare Disease & Pediatrics

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $160k - $180k / year

⏰ Full Time

🔴 Lead

👷‍♀️ Project Manager

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Act as the primary client lead for complex clinical studies or programs • Drive operational delivery across multiple vendors, sub-CROs, and teams • Develop and execute risk-management strategies • Resolve escalated project-level issues • Provide line management and talent development for project management staff • Lead project teams through the design, implementation, tracking, and maintenance of project plans • Adhere to professional standards, SOPs, contracted timelines, and budgets • Oversee TMF Index and Plan, audit readiness, and TMF delivery when contracted by the client • Lead quality control and risk assurance activities • Foster positive client experiences through communication and collaboration • Develop and manage strategic relationship documents, including charters, MSA negotiation, rate card input, operations plans, and quality plans • Initiate process improvement to address variance • Design delivery strategies for large-scale bid defense and perform business development activities • Attract, select, onboard, develop, and retain high-performing talent • Strengthen talent bench and succession • Perform other duties as assigned

🎯 Requirements

• Fluent in English, both written and verbal • Extensive knowledge of the clinical development spectrum and ICH GCP • Advanced proficiency in organizational and time management skills • Sound judgment in high-stakes or ambiguous situations • Exceptional presentation skills for internal and partner executive leadership • Active contribution to continuous improvement and strategic planning • University/college degree in life sciences • Minimum of nine (9) years relevant clinical research experience in a pharmaceutical company/CRO • At least six (6) years of full project management responsibility • Minimum of four (4) years direct or indirect supervisory experience • In lieu of the above experience requirement, a combination of other relevant and equivalent experience may be considered • Preferred therapeutic areas: rare diseases, neonatal and infant pediatric studies • PMP or certification in clinical research preferred

🏖️ Benefits

• Medical • Dental • Vision • Life insurance • Short-term disability (STD) • Long-term disability (LTD) • 401(k) • Paid time off (PTO) or flexible time off (FTO) • Company bonus where applicable