Senior Director, Clinical Operations

Senior Director, Clinical Operations

Remote,USA

This is an interim to hire position with a small yet rapidly expanding biotech, reporting directly into the CMO.

The Senior Director, Clinical Operations leads the planning, coordinating and execution of multiple clinical trials in accordance with project milestones, within budget and with high quality in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines.

Responsibilities:

• Responsible for the oversight providing direction and oversight to CRO Study Teams. Will lead Study Execution to ensure protocol and regulatory compliance
• Responsible for CRO selection and management, investigator recruitment and selection, study start-up, enrollment, data collection, drug projections
• Develops project timelines, to meet department and corporate goals for timely initiation and completion of clinical studies
• Identify study risks and develop and implement mitigation strategies for clinical studies
• Provide senior management with timely updates on progress and changes in scope and schedule
• Coordinate and responsible for oversight of investigator meetings slides and content
• Coordinate and contribute to clinical study reports, protocol writing and other clinical documents in conjunction with Medical Writing and clinical pharmacology.
• Ensure Clinical Trial Master File for assigned trials are being updated by CRO and are inspection ready
• Participate in and implementation of new SOPs and departmental processes.
• Assess feasibility of enrollment across different indications by providing assessment of timelines/rate of patient availability.
• Lead the development of and accountable for all study related plans necessary for trial conduct.
• Mentor junior clinical operations team members.

Requirements:

• Keeps abreast of current industry practices and standards for outsourcing and GCP system requirements
• Self-directed and collaborative while building strong working relationships across multiple departments to finalize documents, including in high-pressure situations
• Demonstrated knowledge of clinical regulatory documentation requirements (familiar with GCP, CTD, FDA, and ICH requirements).
• Demonstrate ability to communicate and write clearly, concisely, and effectively with an aptitude for compilation, analysis, and presentation of data.
• Excellent writing and editing skills with meticulous attention to detail with solid writing and organizational skills.
• Ability to influence without management authority
• Able to problem solve and use good judgement
• Detail oriented
• Strong program management and people management skills
• Subject to COVID-related conditions and restrictions, must be willing to travel domestically and internationally

Please apply right away to avoid dissapointment!

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