Project Director / Sr. Project Director - Cell & Gene Therapy

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

We are looking for an experienced Clinical Project Director/Sr. Project Director to join our Team.

The Project Director (PD) / Sr. Project Director (Sr. PD) for Cell and Gene Therapy Trials is responsible for overseeing and managing all aspects of clinical trials related to cell and gene therapies. 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.

This is a full-time, direct hire opportunity for an experienced PD/Sr. PD residing in the US. Ideal candidates should have a strong background in PM serving as a SME with cell and gene therapy clinical trial experience.

Location: United States (Remote)

Key Responsibilities:

Strategic Planning: Develop and implement strategic plans for cell and gene therapy 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.

Other Responsibilities:

• Actively supports staff learning & development within the company
• Ensures good communication and relationships with current and future clients
• Able to identify client needs and new business opportunities
• Capable of translating protocol requirements into a clear operational strategy for client engagements
• Able to translate guidelines, rules and regulations into clear and usable recommendations
• Actively contributes and participates in client evaluations, visits and bid defenses
• Networks with local and national agencies for future project development in cooperation with other departments

• Drafts and contributes as Subject Matter Expert (SME) in the field of global clinical trial delivery activities to the evaluation/improvement of processes and procedures within the Quality Management System

• Contributes to other areas of the Allucent business as required

Requirements

• Bachelor's degree in life sciences or a related field (advanced degree preferred).