Shire Head, Human Factors and User Research in Lexington, Massachusetts
The Head of Human Factors & User Research leads a team to deliver human factors support in the design and development of combination products, delivery devices and systems. This includes discovery and definition of user needs, characterization of users and use environments, determination of use-related requirements, use-based risk analysis, and conducting formative and summative human factors evaluation. The Head of Human Factors & User Research leads the team to generate and maintain organizational understanding of Shire’s patients and users related to use of Shire products and, with the team, effectively leverages this knowledge base in the design of new products that will transform the user experience. Activities falling under the team’s responsibility include incorporation of user research findings and industrial design input to support early and iterative concept development.
The Head of Human Factors & User Research:
Ensures successful completion of human factors projects and deliverables within boundaries of quality, time and budget.
Provides technical direction to staff, based on significant technical expertise.
Is recognized as an expert by peers and other personnel within and outside the business.
Responsibilities (% of time):
- 25%Manage, identify, hire, develop and recognize technical staff; the team may include senior level engineers. Provide technical direction to staff; interact with a diverse set of technical and educational backgrounds. Select and maintain proper work assignments and scope to challenge and build skills of team personnel.20%Hands-on project support as Human Factors lead15%Ensure technical competency and expertise in the organization related to risk management, development of use-related requirements, and compliance with global human factors standards.15%Responsible for defining procedures for the staff in executing and documenting project work. Provides input on overall Medical Devices department policy. Ensures that the output of the Human Factors & User Research team is of high quality.15%Proactively and regularly communicate with internal customers and development partners to maintain necessary human factors support. Drive collaboration with other user-facing organizations within Shire.5%Develop organizational structure and culture for attracting, developing and retaining top talent.5%Define & execute multi-year strategic plans for the group, including personnel, infrastructure, and equipment/technologies
B.S. in Human Factors or related discipline and 12+ years related experience or an M.S./Ph.D. in Human Factors or related discipline and 8+ years related experience.
Knowledgeable 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 understanding of the business environment and relevant key strategic, operational drivers and competitive environment.
Strong understanding and competency in planning processes and decision making.
Key Skills & Competencies:
Must be able to contribute both as a leader and as an individual contributor as the need arises. E.g., perform usability testing, write reports for regulatory submission, etc.
Must be self-motivated, have strong interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience. Must exhibit tact, diplomacy, and leadership skills. Must be a true team player.
Independent and creative thinker requiring minimum oversight. A self-starter who is pro-active, motivates, and
Understanding of global regulatory requirements for combination products and medical devices in the pharmaceutical development space; quality risk anagement and reliability concepts for development; and the need to deliver quality products and/or processes at all stages of the product/process lifecycle.Creates an inclusive environment where diversity of all kinds is embraced, respected and valued.Knowledgeable in human factors domain, and knowledgeable in policies, practices, trends, technology, and information affecting biopharmaceutical industry. Experience utilizing relevant human factors standards and guidances (e.g., ANSI/AAMI HE75, IEC 62366-1, FDA Guidance)
Has demonstrated effective supervisory skills.
Strong skills in negotiation, group dynamics, conflict resolution, ability to balance concerns of line management with objectives of diverse stakeholders. Significant experience working with and/or leading cross-functional and global teams.
Able to translate strategies into tangible deliverables for team to execute and to manage and resolve complex strategic and operational issues and interactions between programs.
Ability to influence people at all levels in the organization without authority and negotiate competing priorities. Polished communication and presentation skills, including: executive level written and oral recommendations and communications; global and cross-functional communications.
Ability to provide insight into complex multi-functional interdependencies and assist in providing related budget and FTE impact.
Ability to challenge product/project assumptions in order to resolve conflicts, optimize schedule, costs and quality. Ensure alignment of asset goals and objectives.
Knowledge on product lifecycle concepts as outlined in respective FDA, EMA and ICH guidelines.
A talent for problem solving and driving continuous improvement initiatives
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
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.