Director, Clinical Project 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.

About the Position

The Director of Clinical Project Management will provide overall leadership and strategic direction for the clinical project management functions in a technology-driven, AI-focused biotech environment. This individual will be responsible for leading multiple clinical programs across various therapeutic areas and phases (I–IV), ensuring compliance with global regulations, delivering on timelines and budgets, and driving a culture that leverages technology and AI platforms to enhance efficiency and scalability.

Responsibilities

Project Management Oversight

• Provide strategic and tactical guidance for ongoing and newly launched clinical studies, ensuring alignment with corporate and asset development goals, timelines, and budget parameters.
• Maintain accountability for project deliverables, including overall timelines, budget forecasts, and resource allocation.
• Ensure all clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards.
• Champion proactive risk management by identifying and mitigating risks before they escalate.
• Oversee vendor relationships and governance, holding external partners to high standards of quality, cost control, and on-time deliverables.
• Serve as the Operations Lead for clinical assets and associated studies. Step in as the Clinical Project Manager when needs arise.

Operational Strategy and Leadership

• Develop and implement operational strategies for programs and clinical studies.
• Collaborate with cross-functional teams (Clinical Development, Regulatory, Program Management, etc.) to shape and refine Clinical Development Plans, ensuring feasibility and operational excellence.
• Support protocol development and development of essential documents (e.g., Investigator’s Brochures, informed consent forms) by providing critical operational insights.
• Remain current on emerging industry trends, regulatory updates, and best practices, pivoting operational strategies to maintain competitive advantage.

AI and Technology Enablement

• Leverage AI-powered tools and technology platforms to streamline clinical processes.
• Collaborate with internal and external tech partners to evaluate and implement cutting-edge solutions.

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