Director, Clinical Trial Management

About Formation Bio

Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. 

Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others. 

You can read more at the following links:

• Our Vision for AI in Pharma
• Our Current Drug Portfolio
• Our Technology & Platform

At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently.

At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently.

About the Position

The Director of Clinical Trial Management is responsible for leading and overseeing the clinical monitoring aspects of clinical trials from study design through closeout. This role ensures that trials are executed efficiently, on time, and in compliance with all regulatory requirements. The Director will manage a team of Clinical Trial Managers (CTMs) and Clinical Research Associates (CRAs) and will collaborate closely with cross-functional teams to achieve the strategic objectives of the clinical development programs.

Responsibilities

Leadership and Strategy:

• 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.

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.

Team Development and Management:

• 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 m