Global Development Lead - Ophthalmology
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POST DATE 9/9/2016
END DATE 11/19/2016
JOB DESCRIPTIONJob Description
The VP Global Development Team Leader ( GDTL ) will be responsible for the leadership and matrix management of all aspects of multiple Development Programs in Ophthalmology, from the end of preclinical development stage through post-commercialization. This individual will effectively 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 . Individual will work with the Head of Clinical Development and Therapeutic Area Head to define and implement best practices across Development Programs and contribute to considerations with regard to balancing resources across the Development portfolio.
Key areas of accountability include:
Provide strategic business perspective to leadership of Development Program teams and the evolving program strategy; matrix management of Development Program teams
Engagement and communication across business units and functional lines, including impact on strategic thinking at the Research and Development Leadership (RDLT) Team.
Overall Development Strategy and Plan
Accurate and effective budget management for Development Programs, addressing issues as they arise
Assessment of Business Development 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 postmarketing commitments and lifecycle management initiatives.
Be the lead clinical representative at key external business meetings (e.g. with regulatory authorities) and the lead presenter at regulatory Advisory Committee meetings.
Line management and/or mentorship of less experienced Development program leaders and/or Clinical research staff on Program Team
Leadership and matrix management of all aspects of the activities of multiple Development Program Teams, providing a strategic business perspective developing program strategy and modifying program strategy in response to changing business needs. Provide input into performance assessment of program team members.
Communication and engagement with key stakeholders to ensure transparency on program status and alignment on project plans. Act as a key link between Clinical Development and Business Units, and contribute to the Strategic thinking at the Therapeutic Area level. With Head of Clinical Development and TA Head, define an overall strategy for Program leadership, in addition to contributing to decisions related to balancing resources
Overall development strategy and plan
Responsible for tracking progress against goals and composing monthly reports for senior line management and HGT/Shire Leadership team outlining key strategic events for program(s).
Coordination of budget for Development Program, addressing issues as they arise
Assessment of Business Development opportunities which could impact on Development Programs, monitoring external scientific information and competitor activity related to Development Program(s) and modifying program strategy as appropriate.
EDUCATION & EXPERIENCE REQUIREMENTS:
M.D. preferred, or PhD, with deep experience managing Clinical Development projects in pharmaceutical or biotech company. Experience in small and large pharma and in different business models preferred
7 years experience in Ophthalmology field which include both front and back of the eye.
12 years experience in the pharmaceutical/biotechnology industry
Strong knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe, experienced in global drug development
Extensive experience of 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 preferred.
Troubleshooting and solving problems under very challenging timelines while maintaining standards of quality
Experience as an effective mentor. Line management experience preferred.
Strong publication record and experience with external Scientific Advisory Boards preferred.
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 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.
EQUAL EMPLOYMENT OPPORTUNITY
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