Project Director, Early Phase and Translational Research, North America

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

📋 Description

• Manage a portfolio or program of clinical studies along with the Project Managers allocated to awarded studies.

• Ensure studies align with therapeutic area and client-specific requirements.

• Act as the company's representative to clients and uphold customer satisfaction.

• Effectively communicate program deliverables.

• Guarantee that studies adhere to quality standards, SOPs, GCPs, ICH guidelines, and relevant regulations.

• Supervise executed contracts and oversee project financial aspects, including budgets and expenses.

• Monitor project progress, timelines, and analytical tools.

• Maintain knowledge specific to therapeutic areas and clients.

• Implement study-specific insights across assigned portfolios and clients.

• Lead the planning of contingencies and strategies for risk mitigation.

• Provide operational insights during proposal development and pricing.

• Foster performance enhancement, operational efficiency, and innovation.

• Provide oversight in line management and contribute to Project Management leadership.

• Assist in business development initiatives with minimal supervision.

⛳️ Requirements

• Bachelor of Science in a relevant field.

• A minimum of 15 years of experience in the industry.

• At least 5 years of experience at a CRO.

• A minimum of 10 years of clinical project management experience, covering all project phases from initiation to closure, all functional services, and vendor management.

• Experience in clinical trials related to dermatology or rheumatology is essential.

• Proven experience leading concurrent multicentered, multinational Phase III clinical trials.

• Proficient in project budget financial tracking and forecasting.

• Background in project supervision, mentoring, and coaching of project managers.

• Familiarity with business development activities, including proposals, client presentations, and bid defense meetings.

• Strong understanding of Good Clinical Practices and relevant Health Canada and FDA regulations/guidelines.

• Legally authorized to work in North America.

• PMP or PRINCE2 certification is a plus.

• A Master’s degree is advantageous.

• Experience with mid-sized and large studies across various regions is preferred.

🏝️ Benefits

• Flexible work schedule.

• Home-based role.

• Continuous learning and development opportunities.

• Attractive opportunities for advancement.

• Accommodations available throughout the recruitment and selection process for applicants with disabilities, upon request.