Director, Clinical Operations

The Director, Clinical Operations will provide operational and implementation expertise to the project teams under the guidance of the Chief Medical Officer. He or she will lead activities associated with the evaluation, initiation, and management of clinical studies ensuring compliance, managing timelines, budgets and review of all clinical data. The Director, Clinical Operations will serve as the primary contact for the contract research organizations (CROs), laboratory vendors and clinical sites involved in the clinical trials. The Director will need to execute effectively as a member of a cross-functional team, leveraging colleagues from many functions in the company, influencing and leading all clinical operations outcomes. The right candidate willhave the depth of clinical research experience and regulatory knowledge necessary to make independent operational decisions and be comfortable in executing daily operational tasks.

JOB RESPONSIBILITIES

• Oversight of clinical trial site management in conjunction with selected CRO and CRA’s, oversight of clinical trial site monitoring and source documentation verification
• Development of in-house operations SOPs, guidelines and systems
• Lead development and maintain departmental/clinical trial budget
• Assist the Chief Medical Officer in protocol design and provide advice on logistical issues
• Input/prepare patient informed consent document (ICDs)
• Ensure timelines and milestones relating to the clinical trial are being met including but not limited to site activations, enrollment, first patient in, last patient last visit, and reviews for data safety monitoring boards and data monitoring committees.
• Preparation and updates of Investigational Drug Brochures (IBs)
• Preparation and management of clinical trial site budgets
• Preparation of regulatory documents including INDs, IND annual updates, briefing documents, CTAs, and regulatory meeting briefing documents as requested
• Guide clinical trial report preparation and data interpretation
• Preparation of Investigator Alert letters and SAE reports as required and ensure reporting timelines are met

JOB REQUIREMENTS

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• 8 or more years of drug development experience, at least 4 of which in clinical operations in a pharmaceutical or biotech company
• 4 or more years of oncology drug experience
• 2 or more years immunotherapy experience
• Strong working knowledge of the drug development process, with experience in clinical studies from Phase 1 to Phase 3
• In-depth knowledge of ICH/GCP guidelines and FDA regulations.
• Ability to work independently
• Excellent oral and written communication skills
• Travel requirements – international, approximately 20-25%