Director, Study Start-up and Site Partnership - Boston, United States - Alexion Pharmaceuticals,Inc.

Alexion Pharmaceuticals,Inc.
Alexion Pharmaceuticals,Inc.
Verified Company
Boston, United States

2 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Location:
Boston, United States


Job reference:
R-197638

Date posted: 04/18/2024


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 Startup Managers (SSUM), Site Contracts AD (SCAD), Site Alliance Leads (SAL), and Site Solutions Lead (SSL)
  • Oversee startup planning and execution activities, and site contracts and budget negotiations for efficient and expeditious site activations
  • Create operational alignment that results in shorten study startup timelines
  • Lead development and implementation of site solutions (digital/nondigital) to address site gaps, establish preferred vendors for site solutions, and oversee deployment across key institutions
  • Develop 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 startup milestones and institutional partnerships and performance
  • Propose innovative solutions and contingency plans to site activation challenges/risks
  • Consult within COM, Clinical Operations, Clinical Development leadership on new operational model, vendors, and strategies that may positively impact studystartup, site alliance partnerships, site solutions.
  • Collaborate with MAP and/or MSL leadership to ensure mutual site exchanges to create a "One Alexion" mentality
  • Serve as a main point of contact internally for study startup activities, and PICN
  • Participate in the selection and oversight of clinical site vendors related to site solutions
  • Drive 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 priorities
  • Develop People and new talents within the team

Qualifications

  • Bachelor degree in related discipline, preferably in life science, or equivalent combination of education, training and experience
  • Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
  • Minimum 10 years experience in Clinical Operations setting directly engaged in clinical trials
  • Solid understanding of all aspects of clinical drug development process
  • Proven experience in trial setup, contracts and budget negotiations, site operational relationship management
  • Proven experience in leading teams with direct people management experience
  • Ability to set and manage priorities, budget, resources and performance targets
  • Demonstrated experience in developing leading implementation of innovative strategies
  • Strong interpersonal, and exceptional organizational skills
  • Proven 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 processes
  • Well developed problem solving, organizational, and negotiating skills
  • Excellent interpersonal skills across countries, cultures and organizational functions
  • Demonstrates flexibility in schedule and willingness to travel

Preferred Qualifications

  • Experience in running clinical studies for ultrarare disea
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