Shire Head of R&D Global Regulatory Affairs and Drug Safety IT (Senior Director) in Cambridge, Massachusetts
The Head of R&D GRA and DS IT will serve as focal point for Global Regulatory Affairs and Drug Safety for all IT needs, partnering to both understand and anticipate strategic, market and operational needs, and to translate those needs into effective processes and/or technical solutions by coordinating resources across the Shire R&D and IT organizations.
The scope of Global Regulatory Affairs includes CMC, Labelling, Regulatory operations (dossier preparation, submission, management of regulatory authority requests), Regulatory Intelligence and Strategy, and Regulatory Advertising and Promotion. Drug Safety includes global medical surveillance and risk management, risk management strategy, quality and operations for pharmacovigilance and various therapeutic area focused teams.
This role is based in Cambridge, Massachusetts and reports operationally to the Head of R&D IT, and functionally to the Heads of R&D Global Regulatory Affairs and R&D Drug Safety. It is expected that the Head of R&D GRA and DS IT will have a broad understanding of and experience in drug development with specific expertise in at least one of the domains and will continue to deepen the partnership between the IT and R&D teams.
The Head of GRA and DS IT will :
Consult with R&D on technologytrends and delivery options and develop specific technology strategies and roadmaps within the framework of the overall R&D technology strategy.
Partner withclients across GRA and DS throughout the full technology life cycle – fromideationthroughplanning,execution, deployment and operations.
Drive innovation for GRA and DS aiming at delivering both continuous improvement and transformations by leveraging a leading edge technologies from ideation to proof of concept
From a governance perspective, the Head of GRA and DS IT will:
Be an active member of the R&D IT leadership team and IT extended leadership team, advocating for GRA and DR and contributing to the overall R&D technology strategy
Coordinate the informationneeded for theITorganization'sannual planningprocess,includingbudgeting, representing the demand for technology services from R&D
Provide portfolio and resource management capabilities, driving the prioritizationoftechnologyprojects,ensuringthattheyalignwithtechnologythat bestmaximize ROI
Workwithtechnologyarchitects to identifypotentialsolutionsthat match the businessstrategy withthetechnologystrategy.
Work with the Head of R&D IT to benchmark activities with industry peers in key operational areas with the goal of maintaining best practices to measure and drive performance.
40% Develop and drive the R&D GRA and DS technology Strategy, contributing to the business strategy for area and influence for its acceptance.
Develop wide anddeeprelationshipswithinternal technologyteams,external vendors& GRA and DSleadership
Build and execute the long-range business technology strategies for the relevant business areas
Provide consultative support to business strategy planning including new business initiative analysis
Deliver Budget and performance transparency to stakeholders
20% R&D GRA and DS IT Project, Program, Portfolio Management
Lead the GRA and DS IT planning process, analyzing key business initiatives and needs to develop a high impact project portfolio
Sponsor and/or lead R&D GRA & DS IT projects and delivery in accordance with project goals, time and costs.
Consult on and participate in technology aspects of business-sponsored projects and project requests
Manage third party relationships through implementation and ensure an effective transition to appropriate operations staff
20% Co-lead R&D IT innovation process to identify and pilot new ideas to accelerate R&D scientific innovation, drug development and market access.
Use a “fail fast” and low resource impact approach to innovation, engage the business community in ideation challenges focused on specific business objectives, launch/conduct proofs of concept with the relevant R&D teams and manage the transition from concept to production in alignment with the IT planning and prioritization process.
Deliver transverse analytics capabilities and leverage to support the mission of the R&D GRA and DS organizations
10% Develop New Service Capabilities, and increase Operational Efficiency
Develop and deliver support in accordance with Service Level Agreements based on business requirements. Work closely with business partners in understanding and responding to both long-term and short-term R&D GRA and DS goals and needs.
Strengthen the delivery of transverse R&D GRA and DS services, building or leveraging shared applications services .
Collaborate and negotiate with external partners to support system operations development / integration, ensuring reliability, competence, flexibility and cost effectiveness.
10% Be a member of the R&D IT transverse leadership and governance and contribute to the consolidation of various IT management practices such as R&D master technology strategy development, service management, budget and financial planning consolidation, capacity planning, communication and vendor management.
Education and Requirements:
Bachelor'sDegreein the fieldofInformationTechnology,Informatics, Science or a relatedstudy(advanced degree preferred)
Morethan 10 years relevantIT/R&Dexperiencemanagingdirectingtechnologyprojects (required)
Experience with Regulatory (e.g. submissions, labelling, CMC) & Drug Safety processes and systems (one area required)
Morethan 8 yearsworkingin the Pharmaceuticals or LifeSciencesindustry(required)
Morethan 5 years ofmanagementexperienceandfamiliarityworkingincomplex,global matrixorganization either within a IT organization or within R&D (preferred)
M&A/integration experience (preferred)
Experience with budgeting, planning, ROI/NPV model development, and data & technology governance (preferred)
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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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.
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.