Global Clinical Program Lead

Regulatory Jobs; New Haven (CT); On-site; USD 177,000 - 229,000; Full time

Benefits offered by this job

401(k) plan

Health insurance

Paid holidays

Vacation & sick days

Job summary

Celldex is seeking a Global Clinical Project Leader to manage clinical trial execution, develop the operational portion of the development plan, and lead cross-functional teams across trial management, data management, and program strategy. The role emphasizes risk-based management, timely program information, and continuous improvement in development operations.

The candidate should bring 8+ years in pharma/biotech with strong project management, GCP knowledge, and experience in

Qualifications

• BS degree or equivalent with 8+ years pharma/biotech experience; or MS with 6+ years, 2+ in Senior Clinical Trial Manager or similar.
• Experience planning and managing complex clinical programs.
• Dermatology and Allergy experience preferred.
• Technology aptitude including project management, eTMF, etc.
• Experience with data review, analysis and interpretation.

Responsibilities

• Develop and deliver the operational component of the clinical development plan.
• Oversee matrix relationships with Clinical Trial Managers and Data Managers.
• Represent development operations in cross-functional strategy meetings.
• Detect operational risks and develop mitigation plans.
• Provide timely information on the program and foster continuous improvement.
• Stay abreast of clinical operations developments and advise on strategy.

Skills

GCP knowledge

Project management

Data analysis

Communication

Interpersonal skills

Influence without authority

Dermatology/Allergy experience

MS Excel

Cross-cultural collaboration

Rapid adaptation

Education

BS or MS in life sciences

Tools

eTMF

Project management tools

MS Office

Job description

Celldex is seeking a Global Clinical Project Leader to manage clinical trial execution, develop the operational portion of the development plan, and lead cross-functional teams across trial management, data management, and program strategy. The role emphasizes risk-based management, timely program information, and continuous improvement in development operations.

The candidate should bring 8+ years in pharma/biotech with strong project management, GCP knowledge, and experience in