Shire Global Development Team Lead in Lexington, Massachusetts
The Global Development Lead (“GDL”) will be responsible for the leadership and matrix management of all aspects of multiple complex Development Programs, including those focused on multiple indications across geographies, from the end of preclinical development stage through post-commercialization. Will coordinate and manage team activities tailored to address the specific needs of individual programs, and identify innovative approaches to both increase the speed with which therapies can get to market and enhance the value of programs as assessed by alignment with Target Product Profiles (TPPs) and stakeholders in the ‘Circle of Value’. Will work with the Therapeutic Area Head to define and implement best practices and balance resources across the Development portfolio. Key accountabilities:
• Lead the multidisciplinary Global Development Team(s) (GDT) and, if applicable, closely collaborate with the Product Strategy Team (PST) and the Product Strategy Lead (PSL) to provide and execute strategic development plans to rapidly address key unmet medical needs and meet the strategic imperatives of the appropriate business unit (BU)
• Matrix management of GDT members
• Ensure all clinical documents have proper accuracy content, CSR’s, Regulatory Documents, as the individual is ultimately responsible for overall strategy, tactics, and deliverables for the program
• Lead complex development programs such as ones with multiple indications and /or multiple geographic regions and broadly contribute to strategic thinking at the Therapeutic Area level.
• Engagement and communication across business units and functional lines, including impact on strategic thinking at the Development Steering Committee (DSC) and the Pipeline Committee (PLC).
• Partnership with Program Management (PM) representative on the GDT to ensure consistent high quality output from the team, and engagement with PM with regard to exploring opportunities to enhance speed and/or project value
• Overall Development Strategy and Plan and resource and budget planning
• Assessment of BD opportunities which could impact on Development Programs, monitoring external scientific information and competitor activity related to Development Programs and modifying program strategy as appropriate
• Tracking progress against project goals and composing monthly reports for senior management and Shire Leadership teams outlining key strategic events for projects. These documents contain program milestones, strategic imperatives, and financial information regarding projects.
• Responsibilities likely to include post-marketing commitments and lifecycle management initiatives.
• As an experienced Clinical Development professional, take a hands-on role in establishing a detailed clinical development plan, possibly working with a less experienced Clinical representative on the team
• Be a lead clinical representative at key external business meetings (e.g. with regulatory authorities) and may present at regulatory Advisory Committee meetings.
• Line management and/or mentorship of Clinical research staff on GDTs
• Be key point of contact for external key opinion leaders, and potentially media.
• M.D. required with Board eligibility/certification in Allergy/Immunology.
• 10+ years ’industry experience, with deep experience managing Clinical Development projects in pharmaceutical or Biotech Company
• Experience of drug development in Immunology.
• Strong knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe.
• Aware of changing trends in pharmaceutical drug development, and experience in applying new approaches
• Extensive team leadership in a matrix management environment
• Experience with drugs at all stages of Clinical Development and presenting data to regulatory agencies/Advisory Committees. Experience in taking drugs to market highly preferred.
• Experience as an effective mentor. Line management experience highly preferred.
• Strong publication record and experience with external Scientific Advisory Boards preferred.
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees 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.