Shire Device Development Lead in Lexington, Massachusetts
The Device Development Leader (DDL) position is a high impact leadership role responsible for leading the development of the product device strategy, including technology/platform choice, partner/vendor selection, clinical strategy, regulatory strategy, etc.
The DDL role requires a talented leader with proven expertise in overseeing cross-functional, global team activities and is expected to be knowledgeable about the overall device development activities.
As the leader of the device development subteam, the DDL is accountable for device program execution ensuring the translation of product strategy into clear and actionable plans/deliverables. The DDL will also work closely with the Global Development Leader (GDL)/Product Strategy Leader (PSL) on the Early or Late Product Teams (EPT/LPT) as appropriate to ensure alignment of target device profile with target product profile and Shires Device strategy.
The DDL communicates with all governance bodies, and represent the device subteam at EPT/LPT, functional leadership teams and PLC.
Responsibilities (% of time):
The DDL facilitates elaboration, approval, and execution of the global device program strategy
Lead and drive development and execution of Strategic Device Plans, Target Device Profile (TDP), TPP alignment, Long Range Plan, Life Cycle Management Plan, and Geographical Expansion Plan, ensuring alignment to program strategy.
Collaborate and communicate EPT/LPT and Tech Ops Product Team (TOPT) to ensure coordinated evaluation of product opportunities/ scenarios and development of comprehensive, integrated recommendations (e.g., to Governance Committees) and strategic and operational product plans based on program defined objectives and priorities.
Represent Device development team at Shires product governance bodies incl. EPT/LPT as well as pipeline and inline committees (PLC/ILC)
Drive program execution excellence
Develop and lead high performing device development teams
Ensure execution of integrated device development project plans build by GDPM and device sub-team
Drive budgeting process and ensure adequate resource deployment ($ and FTE) in support of the approved integrated device development plan
Facilitate preparations and analyses of device relevant business reviews and routine evaluation processes, and progress against strategy and action plans.
Promote visibility and transparency of information within the device development team, across program sub-teams and EPTs/LPTs to accelerate decision making, obtain alignment, and increase foundational knowledge
Escalate significant deviations from plans and budgets in a timely manner
Ensure patient safety and compliance during program development and LCM
Provide clear direction on product development requirements in alignment with the Product/Device operating model to meet expectations of external customers and business stakeholders.
Demonstrate strong finance and business acumen and oversight of the device program budget and long range plan.
Establish and foster strong collaborative relationships with external industry partners and academia
Contribute to Shire’s device strategy
Support device relevant BD activities as required
Must build and maintain strong relationships with key internal and external partner organizations including but not limited to; Component Suppliers, Contract packagers, Product Strategy Leads, Quality Assurance, Procurement, Business Development, Research and the Brand Teams.
To remain current with developments in their respective specialization or practice by actively engaging in and participating in professional organizations.
Represents device development and external manufacturing on development and commercialization teams as appropriate by interfacing with Regulatory, Marketing, Product Strategy Leaders, Global Labeling Operations and other internal or external customers on new and existing products introductions.
Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous, risk-management based solutions to complex technical challenges.
Bachelor’s degree required, MS desired; MBA or relevant industry experience preferred.
Minimum of 8 years of experience in device development and commercialization with demonstrated success leading multi-site, global or enterprise-wide programs in the biotech/pharmaceutical industry.
Knowledgeable in at least one functional area (proven experience) in the development of a pharmaceutical device; has to be able to assess validity of overall program/project strategy and deliverables.
Proven Leader with ability to manage multiple complex cross-functional teams and processes to deliver key accountabilities.
Demonstrated experience managing programs in different stages of development in diversity of therapeutic areas.
Strong knowledge and understanding of global device product development and commercialization in the pharmaceutical industry.
Strong understanding of the business environment and relevant key strategic, operational drivers and competitive environment.
Excellent knowledge and application of elements of device related product development:
Excellent knowledge and execution of subcontractor management and CMOs.
Strong understanding and competency in planning processes and decision making.
Demonstrated experience using standard program management tools and software including integrated development plans, timelines, risk management, and budget development and monitoring.
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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.