Program Delivery Management

The flex resource performing the Program Delivery Management, IP services will be responsible for the oversight and the training strategy/delivery of Investigational Product (IP) across relevant GCO roles and sites. Activities include engaging with investigational sites as it relates to IP and serving as the internal contact for GCO. The resource will deliver strategic insights and constructive feedback to refine IP study-related documentation, drive protocol training initiatives, and oversee the resolution of IP-related issues at the site level.

Additional services include connecting with key stakeholders and partnerships with the GCO Site Managers, Local Trial Managers, Independent Drug Monitors, and Delivery Unit Trial Delivery Leaders. In addition, there will be close partnering with the IPPI author team as well as relevant stakeholders responsible for inputs to facilitate a successful design of the IP Preparation and Administration Instructions, along with seamless execution of study startup and IP training while adhering to study timelines.

Responsabilities:

• Oversight of studies and focus on investigational product preparation/administration within assigned therapeutic area to ensure alignment/consistency across the portfolio.
• Support development of high-quality training solutions by leveraging a variety of techniques for transfer of IP preparation/administration knowledge, may include other study specific related topics.
• Provides consultation as Subject Matter Experts through the training strategy process to produce high-quality education materials.
• Facilitate assessment of training needs as applicable with various teams to define plans with clear learning objectives.
• Lead internal, sponsor staff training and provide intensive support depending on IP complexity. Act as the main point of contact for resolution of any questions associated with IP.
• Contribute to training or IP process initiatives that can support the business.
• Demonstrates strong presence and authority, leading discussions and ensuring training strategy meets all quality, regulatory, and operational expectations.
• Monitor key risk IP indicators, escalate, and mitigate as required.
• Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment is required.
• Persuasively communicates with relevant internal stakeholders. Confidently advocates for best practices, ensuring all stakeholders adhere to high-quality standards.
• Takes decisive action to resolve inconsistencies, challenge unclear guidance, and escalate concerns when necessary.
• Portfolio support may involve travel to support training initiatives.
• Study portfolio oversight of advanced and highly complex preparation and administration techniques.
• Intensively involved in training or IP process initiatives to support the business with minimal guidance from organization leaders.

Requirements:

• Bachelor's degree in pharmacy/nursing, with an active license. Advanced degrees in a scientific discipline and/or master's degree are preferred.
• Minimum of 5 years' experience in compounding/nursing in clinical or hospital setting. Oncology experience required; Immunology experience preferred.
• Minimum of 5 years experience in clinical research experience acquired in pharmaceutical industry, CRO or investigational site is required. Early Development/First-in-human previous clinical trial experience is required.
• Strong knowledge of drug development, clinical research operations and regulatory requirements, including ICH-GCP, GMP and applicable regulations as required.
• Familiarity with global site practices is required.
• Required experience with training needs assessment, development, and facilitation of training programs with clear learning objectives.
• Experience in preparation of novel pharmaceutical therapies such as gene-therapy or radiopharmaceuticals.
• Experience in leadership role, demonstrating ability to develop and implement strategies, and to foster team productivity and cohesiveness.

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