Description

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, 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 discovery or IND-enabling stages, representing cutting-edge biologics development.

We are seeking a highly skilled and motivated Senior 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 Senior Global Director, Clinical Project Management, will play a critical role in delivering high-quality data and ensuring the success of clinical studies.

Key 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

Senior Director, Global Clinical Project Management - Oncology

Description

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