Director Clinical Operations

Responsibilities

• Provides strategic input to the clinical development plan
• Develops the operational plans for trials within the assigned development program(s)
• Oversees trial execution team to ensure delivery of clinical trial within budget and agreed upon timelines
• Identifies and/or anticipates operational risks and mitigation plans across trials within the development program and escalates issues to senior management as necessary
• Manages the quality of work performed by direct reports (i.e. AD, CTM, CRA, and CTC) through regular review and evaluation of work product. Acting as a coach and mentor
• Serves as the relationship manager for CRO/Vendors and is a member of the joint oversight committee
• Serves as the governance contact for the CRO and clinical vendors
• Reviews CRO/Vendor agreements and negotiates the performance metrics to be outlined within the agreements
• Contributes to Global clinical / regulatory submissions
• Presents status reports of operational execution activities to senior management
• Ensures clinical trials maintain an inspection readiness state throughout the lifecycle of the trial

Qualifications

• 10 years of clinical operations experience in a pharmaceutical, biotech and/or contract research organization (CRO) setting; including management of a CRO
• 7 years supervisory experience, 5 years direct project/trial management experience and 2 years in leadership role
• Strong collaborator with excellent communication skills; “Can do” attitude
• Requires a BS in the health or life sciences or equivalent
• Oncology experience is highly preferred
• Experience with trial master file organization, regulatory documents, inspection preparation/readiness (site and Sponsor) required
• Good working knowledge of the international conference on harmonization (ICH) and good clinical practice (GCP) guidelines and other applicable regulatory guidelines required; basic statistical knowledge preferred
• Excellent computer skills (Microsoft Office Suite, Project, Outlook; Electronic Data Capture and Trial Master File Systems)
• Global Clinical Trial Experience and the ability to support more than one clinical trial is required