Director of Clinical Trial Management

Director of Clinical Trial Management

Requirements

• Bachelor’s degree in life sciences, nursing, pharmacy, or a related field (advanced degree preferred).
• Minimum of 10 years of experience in clinical trial management, with at least 5 years in a leadership role.
• Extensive experience managing clinical trials across multiple phases (I-IV) and therapeutic areas.
• Experience working within a sponsor company.
• Experience working with CROs and managing complex, multi-center clinical trials and/or experience working in an integrated in house clinical trial execution model. Preference given to candidates with experience in the integrated in house clinical trial execution model.
• In-depth knowledge of ICH-GCP, FDA regulations, and global clinical trial guidelines.
• Strong strategic thinking and analytical skills.
• Proven ability to lead and develop high-performing teams in a fast-paced, dynamic environment.
• Strong project management skills, with the ability to manage multiple priorities and meet tight deadlines.
• Excellent communication, interpersonal, and problem-solving skills.
• Ability to travel as required (up to 25%).

Responsibilities

• Develop and implement scalable clinical trial management strategies with a technology first, additional headcount second mentality to ensure the successful execution of clinical studies.
• Provide leadership, direction, and oversight to the clinical trial management team, ensuring alignment with organizational goals and Formation Bio value drivers.
• Facilitate effective communication and collaboration between internal teams, such as Clinical Development, Clinical Data Management, and Site Identification, and external partners, ensuring alignment and collaboration throughout the trial process.
• Maintain up-to-date knowledge of industry trends, regulatory requirements, and emerging best practices in clinical trial management.
• Strategically build and implement in house clinical trial capabilities that are scalable, technology first, incorporate elements of AI, and comply with regulations. Capabilities to include the operational aspects of clinical trials, including protocol development, site selection, data collection, and study monitoring.
• Develop the trial management team and processes to be flexible to both an integrated in house clinical trial execution strategy and outsourcing to a Contract Research Organization (CRO) when needed.
• Support the selection, contracting, and performance of Contract Research Organizations (CROs) and other external vendors when needed.
• Ensure that all clinical trials are conducted in accordance with ICH-GCP guidelines, FDA regulations, and other applicable regulatory requirements.
• Ensure that clinical trials are conducted to the highest quality standards, with a focus on patient safety, data integrity, and regulatory compliance.
• Support internal and external audits and regulatory inspections, ensuring readiness and addressing findings promptly.
• Recruit, mentor, and develop Clinical Trial Managers and CRAs, fostering a culture of excellence and continuous improvement.
• Conduct performance reviews, provide feedback, and support the professional growth of team members.
• Ensure that the clinical trial management team is trained on current SOPs, regulatory requirements, and industry best practices.

Preferred Qualifications

• Advanced degree (e.g., MSc, PhD, MBA) in a related field.
• Experience with global clinical trials and regulatory submissions.