Site Alliance Lead, Associate Director

Alexion Pharmaceuticals - Wilmington, DE

Full-time - Mid Level

Wilmington, DE

Chemical Manufacturing

About the position

The Site Alliance Lead, Associate Director at Alexion is a pivotal role responsible for implementing the operational institution relationship management strategy, particularly focusing on the Partner In Care Network (PICN) for US Country Operations Management (COM). This position requires a collaborative approach, working closely with various business stakeholders to position Alexion as the Sponsor of Choice for clinical sites. The Site Alliance Lead will engage in site management, negotiation, and influential leadership, fostering effective partnerships with institution stakeholders, including clinical site staff, legal, contract, and finance departments, as well as regulatory coordinators for optimizing the IRB pathway. In this role, the Site Alliance Lead will develop and manage a best-in-class institution relationship model aimed at shortening study start-up and recruitment timelines while maximizing patient delivery across Alexion's portfolio of studies. The responsibilities include implementing and maintaining Partner In Care strategies with selected institutions and research networks, establishing strategic partnership models, and strengthening relationships between institutional sites and Alexion's clinical teams. This will enhance portfolio performance and address challenges in site start-up and execution, ultimately making Alexion a preferred partner for these sites. The Site Alliance Lead will also support local study teams in resolving escalated institutional challenges, maintain an internal data platform with best practices and institutional knowledge, and provide operational oversight of institutional performance across various indications. Regular communication with institutions will be essential to support delivery against agreed goals, proactively identifying challenges and implementing actions to drive success. The role involves identifying opportunities and challenges for sites, collaborating with site managers to develop future plans, and ensuring continuous improvement in operational processes. Additionally, the Site Alliance Lead will collaborate with internal Therapeutic Area stakeholders to coordinate discussions regarding Alexion's study portfolio and institution inclusion for PICN. The position requires a data-driven approach to identify valuable institutions for key indications and support tailored feasibility assessments for PICN. The role also involves onboarding institutions into the Partner in Care Network, developing oversight models using innovative tools, and leading the establishment of institution-related business processes to ensure consistency in site management policies and procedures. A comprehensive understanding of institutions and their business practices, along with the competitive clinical trial landscape, is crucial for advising clinical teams on site selection and management strategies.

Responsibilities

• Implement and maintain Partner In Care (PiCN) strategies and activities with selected institutions, research networks, and site management organizations, for prioritized Therapy Areas.
• Establish strategic partnership models and frameworks to be deployed across key clinical institutions including Master and single contracts/ agreements, and governance models.
• Strengthen relationship between institutional sites and Alexion clinical teams to enhance portfolio performance and overcome roadblocks in site start-up and execution.
• Collaborate with local study teams to actively support resolution to escalated institutional level challenges impacting delivery.
• Support maintenance of an internal data platform with latest best practices, facility information, institutional knowledge, process, and materials.
• Provide operational oversight of institutional performance across Alexion indications, and maintain regular communication with institutions to support delivery to agreed goals.
• Monitor delivery to institution partnership agreements, proactively identify challenge areas and implementation actions to drive success.
• Identify opportunities and challenges for the sites and work with site manager to develop future plans to leverage the opportunities and mitigate the obstacles.
• Collaborate with internal Therapeutic Area stakeholders to coordinate presentations and discussions for Alexion study portfolio and institution inclusion for PICN.
• Lead identification of most valuable institutions for key indications, for PICN strategy, using data-driven process balanced with input from internal Therapy Areas stakeholders.
• Support PMCO in tailored short feasibility for PICN by leveraging site profile and institutional knowledge already gathered.
• Drive onboarding of agreed institutions into Partner in Care Network, setting expectations for operational delivery and metrics.
• Develop data driven oversight model using innovative tools and informatics, and routinely review, report, and discuss with institution their performance metrics for activation and recruitment.
• Utilize insights in communication with local stakeholders and collaborate with internal clinical teams to explore, develop and implement strategies to improve institution performance.
• Proactively work with applicable institutions to escalate issues to internal stakeholders if not resolved within a reasonable timeframe.
• Lead the establishment and evaluation of institution-related business processes including development of new work practices.
• Demonstrate comprehensive understanding of institutions and their business practices and the competitive clinical trial landscape.
• Collaborate with PMCO, CRA, MAP, and/or MSL team to conduct mutual site exchanges.

Requirements

• Bachelor degree in related discipline, preferably in life science, or equivalent combination of education, training and experience.
• Minimum 5 years experience in Clinical Operations Senior CRA or Project Management Country Operations, or other fields.
• Solid knowledge of international guidelines ICH-GCP as well as applicable regulations and Clinical Trials Process.
• Strong interpersonal, and exceptional organizational skills.
• Proven experience in building and developing relationships with institution stakeholders.
• Negotiation and influencing skills in the start up and recruitment requirements.
• Proven experience and effective communication skills (written, verbal, and presentation).
• Demonstrated networking and relationship building skills with internal and external stakeholders including institutional staff and CRO partners.
• Ability to adapt to changing technologies and processes.
• Demonstrates flexibility in schedule and willingness to travel.

Nice-to-haves

• Experience in Rare Disease clinical development.
• Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas.
• Good knowledge of the Drug Development Process.
• Excellent understanding of the Clinical Study Process including monitoring, project management, Study Drug Handling Process and the Data Management Process.