Shire Information & Knowledge Integration Lead in Lexington, Massachusetts
The Information & Knowledge Integration (IKI) Lead is experienced in the design, management and operations of PDTS Post-Merger, Acquisition & Divestiture (MA&D) Information & Knowledge Integration, including strategy, planning, execution, and performance improvement initiatives. The IKI Lead can be called upon to oversee and execute multiple, simultaneous information & knowledge integrations post MA&D at any stage of the lifecycle process (preclinical to commercial). The IKI Lead works closely with the Head of Knowledge Management and the PDTS Integration Lead to create and manage adherence to established charter, plans, and timelines for information & knowledge integration, and to guide the CMC SMEs in the tactical execution of IKI processes and activities. Great interpersonal as well as oral and written communication skill; ability to identify risks and escalate issues, as required.
60%: Operational Management
Lead tactical execution of Post-M&A IKI integration, including IKI integration lifecycle
Assess and identify target PDTS/stakeholder systems and repositories of record
Ensure essential transferee IT infrastructures and hard copy data are identified and safeguarded to assure business continuity
Report and escalate findings and risks related to IKI activities and performance improvement opportunities to CMC Team and Business Owner
Collaborate with all appropriate stakeholders on Data Verification scripts
Execute Data Verification Scripts
Participate in operational integration discussions and provides input/recommendations and direction as it relates to IKI activities.
Review folders, files and documents.
20%: Strategic Management
Work with PDTS Integration Lead and SMEs to set priorities, agendas, plan activities and facilitate decision making in line with product goals
Develop relationships and acts as the conduit from transferee to receiver functions at Shire
Facilitate timely & productive team discussions
Identify risks and mitigation/contingency plans
Use decision making tools to help the team make complex development decision
Provide oversight of CMC information & knowledge transfer following asset acquisition.
20%: Project Management
Establish team goals and objectives with the team and their respective functions. Update progress against set milestones.
Provide scenario analysis to support timely decision making to ensure execution per plans
Identify critical issues and discusses with PDTS Integration Lead to devise appropriate mitigation plan
Ensure effective coordination of activities and/or deliverables across functions and external partners.
Apply all standardized project tools to manage and document team progress as well as to communicate effectively to stakeholders.
Create and manage adherence to established charter, plans, and timelines
Assess IKI integration performance management through metrics and reports, including status and completion
Education and Experience Requirements
Minimum Bachelor’s degree in the life sciences, business, chemical or industrial engineering or equivalent required. MBA degree and/or PMP certification desirable.
Minimum 7 - 10 years’ cross-functional experience in the biotechnology/pharmaceutical product development process including manufacturing process, comparability/feasibility studies, stability studies, analytical development and clinical/commercial operations, with documented experience and emphasis in both project management and information management principles and practices.
Knowledge of CMC development type information and its place in the development lifecycle.
Other Job Requirements
Some travel might be required
Roles and responsibilities
Coordinates and schedules team meetings.
Owns program documentation including: agenda, minutes, action items, dashboards, goals and milestones, risk register, mitigation plan, decision log, FTE tracker, timeline, etc.
Resolving project constraints and prioritization of tasks together with Head of Knowledge Management and CMC Lead
Facilitates the use of project management tools to achieve a balanced, data driven and risk-based decision making process
Ensures project progress and upcoming deliverables are understood by the team by using appropriate tools and techniques.
Creates and updates project plan and charter
Reports program status into TOP Team or PDTS team as appropriate
Actively models behavior to support the development and maintenance of a high-performance team via effective meeting management, business communication, and timely follow-up and escalation as appropriate
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.