Associate Project Director - Australia

at  Allucent

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for an Associate Project Director (APD) to join our A-team (hybrid*/remote). As an Associate Project Director at Allucent, you are responsible for overseeing and managing all aspects of clinical trials from start up through to final delivery for a range of therapeutic areas. This role plays a pivotal part in ensuring the successful execution of trials, from initial planning through to completion, with a focus on safety, regulatory compliance, and efficient project management.

• Strategic Planning: Develop and implement strategic plans for Central Nervous System (CNS) or Cell and Gene Therapy (CGT) trials, including defining project objectives, timelines, and resource allocation.
• Trial Management: Oversee the planning, execution, and monitoring of clinical trials, ensuring adherence to protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Budget and Resource Management: Manage project budgets and allocate resources effectively. Monitor expenses, identify cost-saving opportunities, and report financial progress to stakeholders.
• Team Leadership: Lead and supervise a cross-functional team, including clinical research professionals, project managers, and support staff. Foster a collaborative and motivated work environment.
• Regulatory Compliance: Stay up-to-date with evolving regulatory guidelines and ensure that trials are conducted in compliance with relevant regulations (e.g., FDA, EMA).
• Risk Management: Identify potential risks and develop risk mitigation plans to ensure trial success and patient safety.
• Vendor Management: Select, contract, and manage external vendors and partners, such as Contract Research Organizations (CROs) and laboratories, to support trial activities.
• Data Management: Oversee data collection, analysis, and reporting activities, collaborating with data managers and biostatisticians to ensure data quality and integrity.
• Safety Monitoring: Implement safety monitoring protocols and procedures, ensuring timely reporting of adverse events and appropriate interventions.
• Communication: Maintain effective communication with internal teams, external stakeholders, investigators, and regulatory agencies. Provide regular updates on trial progress.
• Quality Assurance: Implement quality control processes and continuous improvement initiatives to enhance trial quality and efficiency.
• Documentation: Ensure accurate and comprehensive documentation of all trial-related activities, including study protocols, informed consent forms, and regulatory submissions.