Associate Director, Clinical Trials

Role Summary

Associate Director, Clinical Trials. Location: New Jersey, US; Cambridge, US; Gaithersburg, US. Full-time.

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.
• Leading 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

Qualifications

• PMP or equivalent certification desirable.
• Knowledge and experience working with legislation and international guidelines (ICH-GCP/CFR) for the performance of clinical research projects.
• Involvement with addressing regulatory inspections or internal process audits. Involved in drafting/reviewing responses to Health Authority and Ethics committee questions
• 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.
• Good communication and presentation skills both written and spoken inclusive of 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, organizational skills, risk/cost management, and performance monitoring.
• Skilled in using Microsoft Office programs as well as good working knowledge of electronic data systems and technical solutions such as eTMF, IWRS, EDC, etc. and developing presentation material.
• Resourceful and demonstrates high level of problem-solving skills. Able to proactively recognize risks and develop mitigations.
• Leadership: builds a well performing team through developing honest relationships and generating trust by demonstrating consistency between words and actions.
• 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

• Global clinical development leadership
• Team leadership and cross-functional collaboration
• Vendor management (CROs and external providers)
• Strategic planning and problem solving
• Effective communication and presentation
• Project management and timeline management
• Experience with eTMF, IWRS, EDC and related systems

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.