Site Alliance Lead, Associate Director (Boston)
AstraZeneca

This is what you will do:

This Site Alliance Lead is accountable for implementating our operational institution relationship management strategy (including Partner In Care Network - PICN) for US Country Operations Management (COM), at Alexion

The Site Alliance Lead will work collaboratively with business stakeholders to position Alexion as the Sponsor of Choice for clinical sites.

This role will require site management, negotiation and influential leadership skills and effective collaboration and partnership with institution stakeholders (clinical site staff, legal, contract and finance departments, regulatory coordinator for IRB pathway optimization).

Additionally, the Site Alliance Lead will collaborate with other functions within Alexion to develop and manage a best-in-class institution relationship model that will allow US COM to shorten study start-up and recruitment timelines and maximize institution patient delivery across our Alexion portfolio of studies.

You will be responsible to:

• 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 (& other key external organizations) and Alexion clinical teams to enhance portfolio performance and overcome roadblocks in site start-up and execution and thereby becoming a partner of choice for the sites.
• Collaborate with local study teams to actively support resolution to escalated institutional level challenges impacting delivery by implementing institution fit for purpose resolutions.
• Support maintenance of an internal data platform with latest best practices, facility information, institutional knowledge, process, and materials, to expedite study level decision making.
• 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, pro-actively 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, initiate plans to improve efficiency, project outcomes and quality for operation process and roles, ensuring continuous improvement of process to execute trials.
• Collaborate with internal Therapeutic Area (TA) stakeholders (Country Operations HCO, Project Management Country Operations (PMCO), Medical Advisor Pipelin (MAP), Medical Monitors, Global Product Team Lead (GPTL), Medical Science Liaison (MSL), and Clinical Development Lead (CPL) aligned to coordinate presentations and discussion 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 knowlege already gathered, and support site identification and selection. Provide portoflio (cross-study) knowledge to applicable internal teams.
• Drive onboarding of agreed institutions into Partner in Care Network, setting expectations for operational delivery and metrics, aligned to business needs at the portfolio level.
• 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 to identify trends and opportunities for improvement.
• Utilize these insights in communication with local stakeholders and collaborate with internal clinical teams, explore, develop and implement strategies and innovative solutions to improve institution performance, and drive efficiency at the institutational level.
• Proactively work with applicable insitutional to escalate issues to internal stakeholders (PMCO, CRA), if not resolved within a reasonable timeframe.
• Lead the establishment and evaluation of instution-related business processes including development of new work practices, ensuring consistency in site management policies and procedures.
• Demonstrate comprehensive understanding of institutions and their business practices and the competitive clinical trial landscape in order to advise clinical teams on study specific site selection or site management strategies.
• Collaborate with PMCO, CRA, MAP, and/or MSL team to conduct mutual site exchanges to create a "One Alexion" mentality

You will need to have:

• 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) and demonstrated networking and relationship building skills with internal and external stakeholders including institutional staff (clinical research, legal, contract and finance departments, regulatory coordinator for IRB pathway optimization), and CRO partners, and Site Mangement Organizations.
• Ability to adapt to changing technologies and processes
• Demonstrates flexibility in schedule and willingness to travel
• The duties of this role are generally conducted in a field environment. As is typical of a field-based role, employees must be able work effectively in a clinical setting; engage in communications via phone, video, and electronic messaging; problem solving skills; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; and posses strong interpersonal skills for site relationship management.

We would prefer for you to have:

• 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.
  
  

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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