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Formation Bio · 3 days ago

Director, Clinical Project Management

New York, NY

Full-time

Hybrid

Director/Executive

$197K/yr - $256K/yr

10+ years exp

Formation Bio is a tech and AI driven pharma company focused on accelerating drug development. The Director of Clinical Project Management will lead clinical programs across various therapeutic areas, ensuring compliance with regulations and driving efficiency through technology and AI.

Artificial Intelligence (AI)BiotechnologyClinical TrialsHealth CareMedicalPharmaceutical

Growth Opportunities

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

Qualification

Clinical project managementRegulatory complianceLeadership experienceAI technology utilizationGlobal clinical trialsStrategic thinkingCommunication skillsInterpersonal skillsProblem-solving skills