Sr. Project Director, Evidence Development Solutions - Oncology

About the role

The Sr. Project Director will lead evidence development projects in oncology, ensuring alignment with regulatory requirements and clinical trial protocols.

Responsibilities

• Oversee project timelines and budgets, coordinating with cross-functional teams including medical writers, statisticians, and regulatory experts.
• Develop and maintain strong relationships with key stakeholders, including pharmaceutical companies, regulatory bodies, and academic institutions.
• Ensure compliance with FDA and other regulatory guidelines, providing guidance on study design and data analysis.
• Manage project risks and issues, implementing mitigation strategies to keep projects on track.
• Conduct regular progress reviews and provide updates to senior management and project sponsors.

Requirements

• Bachelor's degree in a relevant field such as biostatistics, epidemiology, or a related scientific discipline.
• Minimum 8 years of experience in project management, with at least 5 years in oncology research and development.
• Proven ability to manage complex projects involving multiple stakeholders and deliverables.
• Experience with regulatory submissions and clinical trial protocols.
• Strong analytical skills and proficiency in statistical software.
• Excellent communication and interpersonal skills, with the ability to work effectively in a matrix environment.

Qualifications

• Knowledge of oncology research and development processes.
• Experience with oncology-specific regulatory requirements and guidelines.
• Ability to work independently and as part of a team.
• Strong organizational and time management skills.

Skills

• Project management methodologies (e.g., Agile, Waterfall).
• Statistical analysis and data interpretation.
• Regulatory affairs and compliance.
• Stakeholder engagement and relationship building.
• Effective communication and presentation skills.

Benefits

Competitive compensation package, comprehensive benefits, professional development opportunities, and a supportive work culture.

Pay

$120,000 - $150,000 annually, commensurate with experience.

Schedule

Full-time, remote position.