Director, Clinical Project Management

Formation Bio•New York, NY

52d•$205,000 - $250,000•Hybrid

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.

Requirements

Bachelor’s degree in life sciences, nursing, pharmacy, or a related field.
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.
Strong project management skills, with the ability to manage multiple priorities and meet tight deadlines.
Excellent communication, interpersonal, and problem-solving skills.

Nice To Haves

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

Responsibilities

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.
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.
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.