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.
The Global Development Lead (GDL) will be responsible for the leadership and matrix management of all aspects of a dedicated cross-functional device team (PM, device development, PVRM, PD, Quality, Regulatory, etc.), 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'.
Key areas of accountability include:
•Provide strategic business perspective to leadership of Development Program team(s) and the evolving program strategy; matrix management of Development Program team
•Engagement and communication across franchises and functional lines, including impact on strategic thinking at the Franchise Team and Research and Development Team
•Partnership with Program Management (PM) representative on Development Project team 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
•Close collaboration with the GDCL for Hematology programs
•Overall development Strategy and Plan
•Accurate and effective budget management for Development Program(s), addressing issues as they arise
•Assessment of Business Development opportunities which could impact on Development Program(s), monitoring external scientific information and competitor activity related to Development Program(s) and modifying project strategy as appropriate
•Tracking progress against program goals and composing monthly reports for senior management and Shire Leadership teams outlining key strategic events for program(s). These documents contain program milestones, strategic imperatives, and financial information regarding programs
•Responsibilities may include specific post-marketing commitments and lifecycle management opportunities
•Leadership and matrix management of all aspects of the Global Development Team activities, providing a strategic business perspective developing project strategy and modifying project strategy in response to changing business needs. Provide input into performance assessment of program team members. Ensuring program(s) are effectively represented in key meetings with external stakeholders (e.g. regulatory authorities, Regulatory advisory committees, Payor meetings) (25%)
•Communication and engagement with key stakeholders to ensure transparency on program status and alignment on project plans (20%)
•Overall development strategy and plans (15%)
•Coordination of budget for Development Program(s), addressing issues as they arise (10%)
•Assessment of Business Development opportunities which could impact on Development Program(s), monitoring external scientific information and competitor activity related to Development Program(s) and modifying program strategy as appropriate. Provide a key link to external Key Opinion Leaders in area(s) of focus. (15%)
•Responsible for tracking progress against goals and composing monthly reports for senior line management and Shire Leadership team outlining key strategic events for program(s). These documents contain program milestones, strategic imperatives, and financial information regarding program(s) (15%)
•M.D. with experience managing a Clinical Development program in pharmaceutical or biotech company preferred; could be Ph.D. if relevant experience depending on program needs
•>8 years of experience in the biotechnology or pharmaceutical industry preferred
•3-5 years of experience in genomics, genetics, gene therapy or related fields preferred
•Experience of drug development in hematology and/or rare diseases preferred
•Strong knowledge and understanding of the current technical and regulatory standards for drug and biologic development in US and Europe.
•Experience of team leadership in a matrix management environment preferred
•Experience interacting with CDR and/or CBER and with taking drugs and/or biologics to market and presenting data to regulatory agencies/Advisory Committees preferred
•Experience in modifying program plans and defining creative solutions to meet business needs.
•Troubleshooting and solving problems under very challenging timelines while maintaining standards of quality
•Ability to lead and facilitate a global cross-functional/virtual team. Ability to address questions and concerns across multiple lines and stakeholder groups.
•Applying strategic and business thinking, while also ensuring operational excellence.
•Requires excellent interpersonal skills including active listening, effective meeting management, negotiation, and optimizing group dynamics. Must be open to the ideas of others and utilize different perspectives to drive towards creative solutions.
•Matrix management and influencing skills. Ability to address poor performance in a professional manner and reward and recognize high performance.
•Ability to drive to decisions at the project, DSC, PLC and Franchise Team level
•Excellent knowledge base in Regulatory, Clinical, and CMC/Manufacturing
•Excellent oral and written communication skills
Will work with the following Functions:
Work with Franchise Team to define Target Product Profile(s) that meet business needs. Decides on appropriate membership of Development Project team and any changes that may need to be made. Work with Development Program team to define and implement a project plan based on an agreed TPP. Within agreed budget, responsible for project execution and exploration of innovative approaches to accelerate speed to market and increase value of program. When there are multiple options, is responsible for the recommendation of a path forward. Incorporate external information (e.g. from scientific meetings, competitor intelligence) into program planning, adjusting plans as necessary to meet business objectives. Represent Project Team in meetings with senior leadership, and influence future project and franchise plans.
Key contacts are members of the Development Program team, which will generally include but is not restricted to representatives from Research, Clinical Research, Clinical Operations, Regulatory, Technical Operations and Commercial. Reports directly to Therapeutic Area Head, Hematology and engages to discuss project status, challenges and opportunities. Links to Franchise team, either directly or via a senior Clinical Development representative. Engages with leadership of different lines to discuss issues as appropriate. Links to Human Resources to engage on ways to enhance individual and team performance. Forms effective relationships with external Key Opinion leaders in areas of focus.
Domestic and International travel required as necessary for face to face meetings with key stakeholders (particularly Nyon office), meetings with external key stakeholders, and attendance at external scientific and business meetings related to area of focus.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.