Associate Director, Clinical Trial Management

Role Summary

Associate Director, Clinical Trial Management responsible for leading complex clinical trials, coordinating cross-functional teams, and ensuring program success across multiple sites in Cambridge, MA; Gaithersburg, MD; and New Jersey. Oversees CROs and vendors, manages study timelines, and maintains inspection readiness.

Responsibilities

• Lead one or more complex/large scale clinical trials in early or late stage development within a program
• Lead communications, issue escalations and help teams within the program to further develop
• Manage the Clinical Research Organization (CRO) and vendor(s) related to clinical program level deliverables
• Manage clinical study timelines for the program(s)
• Ensure inspection readiness throughout the clinical program lifecycle
• May be responsible for line management of one or more direct reports

Qualifications

• Required: Minimum 8 years of experience in pharmaceutical/biotech or related industry with at least 6 years in Global Clinical Development leading cross-functional teams
• Required: Bachelor’s degree in the life sciences or related field; advanced degree preferred
• Preferred: Experience with personalized mRNA vaccines in oncology clinical studies
• Desirable: PMP or equivalent certification
• Required: Knowledge and experience with legislation and international guidelines (ICH-GCP/CFR) for clinical research
• Required: Involvement with regulatory inspections or internal process audits
• Required: Involvement in drafting/reviewing responses to Health Authority and Ethics committee questions
• Required: Strong listening and communication/presentation skills (written and oral); ability to communicate strategy across functions
• Required: Project management skills including teamwork, analytical/problem-solving, time management, organizational, risk and cost management, and performance monitoring
• Required: Proficiency with Microsoft Office (Word, Excel, PowerPoint, MS Project) and working knowledge of electronic data systems (eTMF, IWRS, EDC) and creating presentation materials
• Required: Resourceful, with strong problem-solving skills and ability to proactively identify risks and develop mitigations
• Required: Ability to build and lead a high-performing team and promote open, collaborative environments
• Required: Proactive in taking on responsibilities in ambiguous, rapidly changing environments

Education

• Bachelor’s degree in life sciences or related field; advanced degree preferred