Director, Study Start-Up and Site Partnership

This is what you will do

This Director, Study Start-Up and Site Partnerships is accountable for direction and oversight of the site activation process including contract and budget negotiations, and accountable for development and implementation of our operational institution relationship management strategy (including Partner In Care Network - PICN) for Country Operations Management (COM), at Alexion

The Director, Study Start-Up and Site Partnerships will work collaboratively with business stakeholders to position Alexion as the Sponsor of Choice for clinical sites.

This key role will require operational and strategic leadership skills, and role’s priority is to increase efficiencies in site start-up process and establish effective collaboration and partnership with institution stakeholders (clinical site staff, legal, contract and finance departments, regulatory coordinator for IRB pathway optimization).

Additionally, the Director, Study Start-Up and Site Partnerships will collaborate with other functions and leaders within COM (Head of COM and TA-aligned Directors, COM) and Alexion stakeholders (ClinOps, ClinDev) to develop and manage a best-in-class study start-up, institution relationship model, to maximize institution patient delivery across our Alexion portfolio.

You will be responsible to

Lead centralized team of Study Start-up Managers (SSUM), Site Contracts AD (SCAD), Site Alliance Leads (SAL), and Site Solutions Lead (SSL)Oversee start-up planning and execution activities, and site contracts and budget negotiations for efficient and expeditious site activationsCreate operational alignment that results in shorten study start-up timelinesLead development and implementation of site solutions (digital/non-digital) to address site gaps, establish preferred vendors for site solutions, and oversee deployment across key institutionsDevelop institution alliance strategy (including PICN)Direct and manage SAL to implement and maintain institution alliance strategy and activities with selected institutions, research networks, and site management organizations, for prioritized Therapy Areas.Establish strategic partnership models and frameworks to be deployed by SAL across key clinical institutions including Master and single contracts/ agreements, and governance models.Establish and measure KPIs to oversee study start-up milestones and institutional partnerships and performancePropose innovative solutions and contingency plans to site activation challenges/risksConsult within COM, Clinical Operations, Clinical Development leadership on new operational model, vendors, and strategies that may positively impact study-start-up, site alliance partnerships, site solutions.Collaborate with MAP and/or MSL leadership to ensure mutual site exchanges to create a “One Alexion” mentalityServe as a main point of contact internally for study start-up activities, and PICNParticipate in the selection and oversight of clinical site vendors related to site solutionsDrive the hiring of new people and onboarding of team, setting goals and expectations for operational delivery and metrics, aligned to business needs at the portfolio level.Work in collaboration with US COM Leadership team to support delivery of COM vision, mission and prioritiesDevelop People and new talents within the team

Qualifications

Bachelor degree in related discipline, preferably in life science, or equivalent combination of education, training and experienceExcellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDPMinimum 10 years experience in Clinical Operations setting directly engaged in clinical trialsSolid understanding of all aspects of clinical drug development processProven experience in trial set-up, contracts and budget negotiations, site operational relationship managementProven experience in leading teams with direct people management experienceAbility to set and manage priorities, budget, resources and performance targetsDemonstrated experience in developing leading implementation of innovative strategiesStrong interpersonal, and exceptional organizational skillsProven experience and effective communication skills (written, verbal, and presentation) and demonstrated networking and relationship building skills with internal and external stakeholders including senior leaders internally, and institutional staff and vendors, CRO partners, and Site Mangement Organizations.Ability to adapt to changing technologies and processesWell developed problem solving, organizational, and negotiating skillsExcellent interpersonal skills across countries, cultures and organizational functionsDemonstrates flexibility in schedule and willingness to travel

Preferred Qualifications

Experience in running clinical studies for ultra-rare diseases and capability to develop and implement innovative solutions for optimizing the conduct of rare disease studies.Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas.Ability to work in an environment of remote collaboratorsHighly organized with demonstrated ability to successfully manage multiple programs in parallelAbility to analyze current process and identify potential gap areas and successful execution of improvement plansManages change with a positive approach for self, team, and the busienss. Sees change as an opportunity to improve performance and add value to the businessAbility to look for and champion more efficient and effective methods/process of deliverying quality clinical trials with reduced budget and in less timeTeam oreinted and flexible, ability to respond quickly to shifting demands and opportunities