Newly combined with Baxalta, Shire is now the leading global biotechnology company focused on serving people affected by rare diseases and highly specialized conditions. These diseases are often misunderstood, undiagnosed and life-threatening. Our 22,000 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.
At Shire, we are dedicated to expanding, building and sustaining leadership across our key therapeutic areas through our extensive portfolio of products, innovative pipeline and collaborative approach to working with diverse partners around the globe. We strive to earn and keep the trust of our patients, their families and physicians, and all others who support and advance their care. Working together, the possibilities for our patients, healthcare partners and employees are unprecedented, with significant growth potential for our shareholders.
This position is responsible for supporting multiple Clinical Development Programs in a number of therapeutic areas including Oncology, Hematology and Immunology. The incumbent is responsible to provide oversight of the supply chain planning and execution of a broad range of clinical trials involving small molecules, biologics and monoclonal antibodies. In addition, the Clinical Supply Chain Manager participates on multiple cross-functional project teams with responsibility to communicate clinical supply requirements and provide supply chain expertise as required to ensure project milestones are met.
• In partnership with key stakeholders from Clinical Operations, Medical, Quality and Regulatory oversee the development of a Clinical Supply Plan that documents the study design, product requirements, and study assumptions e.g. enrollment, target countries, number of sites, etc. for each study included in a Clinical Program.
• Oversee the development of the clinical demand forecast on a study and program level and communicate this monthly to the Supply Chain Planning team, as well as key stakeholders e.g. Operations, R&D, Project Management, to ensure seamless coordination of demand and supply
• On an ad hoc basis prepare clinical demand/supply scenarios using different combinations of inputs and assumptions to project both short-term and long-term supply availability
• Establish collaborative relationships with Supply Chain counterparts at alliance Partners to facilitate communication, planning and close cooperation in support of Clinical Program requirements
• Partner with Contract Manufacturing (CMO) team members assigned to the project team to ensure close communication and alignment of Clinical Program requirements with production capacities and timelines
• Proactively identify issues with the potential to impact a clinical study and/or program and engage with key stakeholders to highlight risks and find solutions
• Periodically conduct training sessions for key stakeholders and cross functional team members on clinical supply chain processes and procedures as detailed in the Partnership manual
• Lead continuous improvement projects to drive significant increases in operational efficiency and cost reduction
• University degree (BA/BS) required
• MBA and APICS Certification preferred
• Minimum 8-10 yrs. experience in Supply Chain/Clinical Supply Chain
• Proven leadership skills including leading projects with broad scope, cross functional nature and impact outside supply chain
• Demonstrated ability to simplify complex operational information and ensure understanding of cross functional partners
• Strong analytical and problem-solving skills required for resolving issues in a complex, highly regulated environment
• Excellent communication skills (verbal, written and presentation) with the ability to effectively communicate information and ideas to diverse audiences
• Capable of working in a fast paced environment with limited supervision. Candidate must be flexible, adapt quickly and have the ability to manage multiple tasks and priorities
• Experience with Lean/Six Sigma/Process Excellence tools, training and/or certification preferred. Green belt certification preferred
• Ability to embrace change, challenge the status quo and drive improvements to processes and products
• Solid team player with ability to build rapport with team members at all levels of the organization
• Expert knowledge of Excel, as well as extensive experience using it for forecasting, creating demand/supply scenarios, analyzing tradeoffs between business objectives, etc.
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.