Director, Project Management – Rare Disease & Pediatrics

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

📋 Description

• Serve as the principal client liaison for intricate clinical studies or programs.

• Oversee operational delivery across various vendors and teams.

• Formulate and implement risk management strategies.

• Address escalated project challenges.

• Provide leadership and talent development for project management personnel.

• Act as the main client contact for designated clinical studies or programs.

• Create strategies to mitigate risks and enhance operational execution.

• Leverage staff to optimize contributions and organizational efficiency.

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

• Establish and nurture relationships with key stakeholders while growing client portfolios.

• Guide project teams through the design, implementation, monitoring, and maintenance of project plans.

• Ensure compliance with professional standards, SOPs, contracted timelines, and budgets.

• Manage TMF Index and Plan, audit readiness, and TMF delivery as per contract.

• Lead quality assurance and risk management activities.

• Cultivate positive client experiences through effective communication and collaboration.

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

• Initiate process enhancements.

• Develop delivery strategies for large-scale bid defense and engage in business development efforts.

• Attract, select, onboard, develop, and retain top-tier talent.

• Enhance talent bench strength and succession planning.

⛳️ Requirements

• Proficient in English, both written and spoken.

• Comprehensive understanding of the clinical development landscape and ICH GCP.

• Highly skilled in organizational and time management abilities.

• Sound decision-making in high-pressure or ambiguous situations.

• Outstanding presentation skills for all levels, including internal teams and partner executive leadership.

• Contribute to ongoing improvement initiatives and strategic planning efforts.

• Hold a university/college degree in life sciences.

• A minimum of nine (9) years of pertinent clinical research experience within a pharmaceutical company/CRO, with at least six (6) years of full project management responsibility.

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

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

• PMP or certification in clinical research is preferred.

🏝️ Benefits

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 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.