Global Director, Clinical Project Management

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Bothell, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

We are seeking a highly skilled and motivated Global Director, Clinical Project Management (CPM) to join our dynamic team. The successful candidate will oversee and coordinate global clinical trials from initiation through to completion. This role involves ensuring compliance with regulatory requirements, managing study timelines and budgets, and fostering effective communication among stakeholders. The global Director, Clinical Project Management will play a critical role in delivering high-quality data and ensuring the success of clinical studies.

This position requires onsite hybrid work model in Princeton, NJ.

Responsibilities

• Oversee the planning and execution of global clinical trials
• Develop and implement study protocols, timelines, and budgets.
• Manage all aspects of clinical trial operations, including site selection, initiation, monitoring, and closeout.
• Ensure compliance with Good Clinical Practice (GCP) and regulatory guidelines.
• Coordinate with cross-functional teams, including investigators, vendors, and regulatory bodies.
• Monitor trial progress and manage data collection to ensure accuracy and integrity.
• Identify and mitigate project risks
• Oversee a team of regional CPMs, CRAs and CTAs.
• Ensure the preparation and submission of regulatory documents are compliant with local regulatory standards and maintained per good clinical practice.
• Conduct regular meetings with study teams and provide updates to stakeholders.
• Coordinate with external vendors and partners involved in the trial
• Support development of key process initiatives and SOPs internally
• Oversee vendors supporting trial execution

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, or a related field.
• Minimum of 10 years of experience in clinical trial management, including at least 5 years in a direct line management role.
• Strong understanding of GCP and regulatory requirements.
• Excellent organizational and project management skills.