Associate Director, Clinical Trials

Role Summary

Associate Director, Clinical Trials responsible for leading one or more complex/large-scale clinical trials in early or late-stage development within a program, with global study management responsibility. Location: New Jersey, US; Cambridge, US; Gaithersburg, US. This is a full-time role.

Responsibilities

• Leads 1 or more complex/large scale clinical trial(s) in either early or late-stage clinical development within a program (+10 years of experience).
• Oncology experience required, registrational trial experience preferred.
• Directs communications, issue escalations and helping the teams within the program to further develop.
• May have more junior trial managers reporting. Global study management experience needed.
• Manages the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables
• Manages clinical study timelines for the program(s)
• Ensures inspection readiness throughout the clinical program lifecycle

Education

• 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.

Qualifications

• Required: Minimum 10 years of experience in pharmaceutical/biotech or related industry with at least 6 years of experience in Global Clinical Development leading cross-functional teams.
• Required: Knowledge and experience working with legislation and international guidelines (ICH-GCP/CFR) for the performance of clinical research projects.
• Required: Involvement with addressing regulatory inspections or internal process audits. Involved in drafting/reviewing responses to Health Authority and Ethics committee questions.
• Preferred: PMP or equivalent certification.
• Required: Good communication and presentation skills both written and spoken; able to communicate strategy and decisions across different functions; good listening skills.
• Required: Standard use of Project Management skills including teamwork, analytical and problem-solving, time management, organizational skills, risk/cost management, and performance monitoring.
• Required: Skilled in using Microsoft Office programs and good working knowledge of electronic data systems and technical solutions such as eTMF, IWRS, EDC, etc. and developing presentation material.
• Required: Resourceful and demonstrates high level of problem-solving skills. Able to proactively recognize risks and develop mitigations.
• Required: Leadership: builds a well performing team through developing honest relationships and generating trust by demonstrating consistency between words and actions.
• Required: Promotes an open team environment by allowing differing points of view to be expressed. Proactive in assuming responsibilities even when dealing with ambiguity in a rapidly changing environment.

Skills

• Leadership and people management
• Strategic thinking and decision-making
• Cross-functional collaboration
• Excellent written and verbal communication
• Analytical and problem-solving abilities
• Project management and organizational skills