Director, Project Management – Rare Disease & Pediatrics

This is a fully remote position, open to applicants in Italy.

📋 Description

• Serves as the primary client lead for intricate clinical studies or programs.

• Drives operational execution across various vendors and teams.

• Formulates and implements risk-management strategies.

• Addresses escalated project challenges.

• Provides line management and fosters talent development for project management personnel.

• Acts as the principal client contact for designated clinical studies or programs.

• Creates strategies to mitigate risk and enhance operational performance.

• Supervises line management and talent development for Individual Contributors and/or Managers of Project Managers.

• Cultivates stakeholder relationships and broadens client portfolios.

• Guides project teams through the design, execution, monitoring, and upkeep of project plans.

• Ensures compliance with professional standards, SOPs, contractual timelines, and budget constraints.

• Manages TMF Index & Plan, audit preparedness, and TMF delivery as per client agreements.

• Directs quality control and risk management activities.

• Promotes positive client interactions through effective communication and collaboration.

• Oversees strategic client relationship documents, including charters, MSA negotiations, rate card inputs, and operational and quality plans.

• Initiates process enhancements to address variances.

• Designs delivery strategies for large-scale bid defenses and engages in business development efforts.

• Attracts, selects, onboards, develops, and retains top-tier talent.

• Reinforces the talent pool and succession planning.

• Performs additional duties as assigned.

⛳️ Requirements

• Proficient in English, both written and spoken.

• In-depth understanding of the clinical development spectrum and ICH GCP.

• Advanced organizational and time management skills.

• Sound judgment in high-pressure or ambiguous situations.

• Outstanding presentation skills for internal and partner executive leadership.

• Active engagement in continuous improvement and strategic planning initiatives.

• University or college degree in life sciences.

• A minimum of nine (9) years of relevant clinical research experience in a pharmaceutical company or CRO.

• At least six (6) years of comprehensive project management responsibility.

• Minimum of four (4) years of direct or indirect supervisory experience.

• Preferred therapeutic areas include rare diseases, neonatal, and infant pediatric studies.

• PMP or certification in clinical research is preferred.

🏝️ Benefits

• Additional compensation, including bonuses and benefits, in line with company policies.

• Salary may vary based on full-time or part-time work schedules.

• EEO and accommodations support.