Associate Director, Clinical Trial Management

Role Summary

Associate Director, Clinical Trial Management. Location: Cambridge, US; Gaithersburg, US; New Jersey, US. Full-time. Job ID: 9974.

Responsibilities

• Lead one or more complex/large scale clinical trial(s) in either early or late stage clinical development within a program
• Lead communications, issue escalations and help the teams within the program to further develop
• Manage the Clinical Research Organization (CRO) and vendor(s) as it relates 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

• Minimum 8 years of experience in pharmaceutical/biotech or related industry with at least 6 years experience in Global Clinical Development leading cross-functional teams
• A Bachelor’s degree in the life sciences or a university degree in a related field with experience in the health industry. Advanced degree preferred
• Preferred experience with personalized mRNA vaccines in oncology clinical studies
• PMP or equivalent certification desirable
• Knowledge and experience working with legislation and international guidelines (ICH-GCP/CFR) for the performance of clinical research projects
• Involved with addressing regulatory inspections or internal process audits
• Involved in drafting/reviewing responses to Health Authority and Ethics committee questions
• Good listening and communication/presentation skills both written and spoken, including confident, articulate, and professional speaking abilities
• Able to communicate strategy and decisions across different functions
• Standard use of project management skills including teamwork, analytical and problem-solving, time management and organizational skills, risk and cost management, and performance monitoring
• Skilled in using Microsoft Office programs (Word, Excel, PowerPoint, MS Project) as well as good working knowledge of electronic data systems and technical solutions such as eTMF, IWRS, EDC, etc., and developing presentation material
• Resourceful with high level of problem solving skills; able to proactively recognize risks and develop mitigations
• Builds a well-performing team through developing honest relationships, and generating trust by demonstrating consistency between words and actions
• Proactive in assuming responsibilities even when dealing with ambiguity in a rapidly changing environment

Skills

• Strategic communication and cross-functional leadership
• Clinical trial program management
• Vendor/CRO management
• Regulatory knowledge (ICH-GCP/CFR)
• Risk assessment and mitigation
• MS Office and eTMF/IWRS/EDC systems

Education

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

Additional Requirements

• Travel: Not specified in source