External Partners is an Alliance Management group that sits within Clinical Development Operations with the primary responsibility of maximizing the value of the relationships with Shire Strategic CRO sourcing partners supporting the portfolio (Phase 1-IV). The intent is for that value to be translated into improved business terms, increased productivity, reliable quality, strategic innovation, and enhanced working relationships. The Director is expected to collaborate with key internal and external stakeholders, at a departmental and a cross-department Clinical Development Operations level to ensure Shire Vendors perform to the highest level. The Director is tasked with the following overarching responsibilities:
• Partner with Global Procurement and relevant functions to provide leadership and direction on strategic sourcing strategy and associated operating models.
• Build an understanding of the assigned departmental Vendors, their organization and capabilities to anticipate opportunities & risks with those Vendors.
• Implement effective governance and assist departments to build strong relationships to maximize performance and value delivered by CRO strategic partner
• Create a culture of joint accountability and enhanced partnering skills within Shire to ensure CRO performance
• Facilitate efficient and collaborative resolution of problems and conflicts with CRO and on behalf of CROs within CDO.
60%: CRO Alliance Management Subject Matter Expert
Work closely with assigned CDO Functions, act as the CRO Alliance Relationship subject matter expert and be a point of escalation to help the Functions manage their relationships with CROs. When needed and act as the key alliance point of contact within CDO for specific Vendors and lead by example for resolution of Vendor issues. Develop common processes (best practices that can be consistent and aligned across departments) for managing vendors across CDO.
• Implement Governance & monitor performance: Implement Shire-defined governance structures for Strategic CRO partners, using Service Level Agreements, Key Performance and Quality Indicators and other methods to monitor and correct Vendor performance
• Communicate/build a partnering culture: Enable CROs to be successful through facilitation of communication with Shire stakeholders, both informally and via the governance process. Build a culture of partnering behaviors, and mediate for teams with negative dynamics in the interest of resolving the situation before it becomes irreparable.
• Issue resolution: Proactively communicate internally and externally in the interest of fact finding and determining a fair and reasonable win/win solution to any issue. Lead the process to prioritize issues requiring escalation to management via the governance process. Ensure the timely follow-up on issues requiring resolution providing clear communication on status to applicable stakeholders.
• Portfolio Management: Apply lessons learned across the CRO portfolio in the interest of greater efficiency (operational, technical and financial)
• Risk Analysis: Partner with Shire leadership, and other key stakeholders to drive strategic discussions around CRO objectives, problem areas requiring resolution, and risk identification and implement appropriate mitigations
20%: Sourcing Strategy/Vendor Selection
• Departmental: Partner with the Functional stakeholders to assist in identifying optimal operating models and implementing business process for outsourcing services in support of the Shire portfolio. Look for opportunities to align sourcing, business and operational process across CDO Departments.
• CDO level: Work with key stakeholder such as Global Procurement and other business partners to review key categories of vendor services on a timely basis to ensure optimal vendor selection and identification of alternative, high quality service providers as needed. Communicate expectations of preferred CROs, their capabilities, business process, strength/weakness, level of quality and overall performance within Shire.
• Ongoing contribution to process improvement both within the External Partners department, and extending to the wider CDO organization is expected. CRO Alliance Managers will lead work streams or collaborate in other Functional Initiatives to enhance the Shire- Vendor effectiveness and efficiency.
• While the Director may be the POC for one or several CDO Functions, sharing of knowledge within the External Partners department is considered a critical component of the role in order to raise awareness and implement portfolio level corrective action, methodologies and cross-vendor comparisons.
Education & Experience Requirements:
• Minimum of a Bachelors Degree required, preferably in a scientific field; MS, MBA, Ph.D. or other advanced degree preferred
• 12+ years of experience in project/relationship management, or leading cross-functional programs, including 5 or more years or more in clinical research, or alliance management in pharmaceutical, biotechnology and/or CRO
• Education, experience and documented results in providing vendor management support/relationship management or cross functional team management.
• Experience in problem solving, negotiations, presentation and collaborative team-building with non-direct reports required
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
Our employes come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
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At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.