Director of Clinical Project Management

Summary

Join Formation Bio, a tech and AI-driven pharma company, as the Director of Clinical Project Management. Lead and strategically direct clinical project management functions, overseeing multiple clinical programs across various therapeutic areas and phases (I-IV). Ensure compliance with global regulations, meet timelines and budgets, and foster a culture leveraging technology and AI for efficiency. Develop and implement operational strategies, collaborate with cross-functional teams, and champion AI-powered tools. The role requires a Bachelor's degree in a related field, 10+ years of clinical project management experience (5+ in leadership), and in-depth knowledge of ICH-GCP and FDA regulations. Formation Bio offers a competitive salary, equity, generous perks, hybrid flexibility, and comprehensive benefits.

Requirements

• Bachelor’s degree in life sciences, nursing, pharmacy, or a related field (advanced degree preferred)
• Minimum of 10 years of clinical project management/clinical operations experience, including at least 5 years in a leadership capacity
• Proven track record in managing complex global trials across multiple phases (I–IV) and therapeutic areas
• Experience working within a sponsor company
• Experience in the integrated in house clinical trial execution model
• Experience working with CROs and managing complex, multi-center clinical trials
• 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

• Provide strategic and tactical guidance for multiple concurrent clinical studies, ensuring alignment with corporate 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, programs, and studies. Step in as the Clinical Project Manager when needs arise
• 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 Strategic Development Plans and 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
• Leverage AI-powered tools and technology platforms to streamline clinical processes
• Champion a “tech-first, headcount-second” approach to scale programs and teams efficiently, reducing human error, accelerating timelines, and improving data quality
• Collaborate with internal and external tech partners to evaluate and implement cutting-edge solutions, ensuring organizational readiness and training for seamless adoption

Preferred Qualifications

Advanced degree (e.g., MSc, PhD, MBA) in a related field

Benefits

• Equity
• Generous perks
• Hybrid flexibility
• Comprehensive benefits