Shire Lead, Advanced Drug Delivery Tech Dev in Lexington, Massachusetts

R0024479 Lead, Advanced Drug Delivery

Primary Duties

Devices/delivery systems constitute the “user interface” for patients and customers using Shire products, are key to the user experience. The Shire Device Strategy and Technology Development (DSTD) group in Lexington, Massachusetts assesses drug delivery requirements for early-stage programs and life-cycle enhancements for on-market products, recommends potential device solutions, performs feasibility assessments and develops business cases to support device project team assignment, and leads technology transfer to Device Development team. Working closely with commercial, clinical development, device and drug product partners, the DSTD group is responsible for driving early stage device/delivery system initiatives to “entry to development.”

Key activities include:

  • Lead identification and assessment of new/emerging drug delivery technologies and partners with potential application to Shire products;

  • Plan and lead realization of novel drug delivery/device concepts through prototyping, feasibility demonstration (“proof of concept”) and transfer to Device Development;

  • Lead cross-functional Product-Device Strategy sub-teams, and collaborate with key stakeholders (commercial, clinical development, device) to drive development of Target Device Profile (TDP) and business case development for project justification and approval by governing bodies;

  • Collaborate with commercial and human factors partners in user research efforts to uncover unmet user needs;

  • Participate and support clinical advisory board meetings to uncover clinical value proposition for delivery devices;

  • Develop presentations to seek endorsement of strategy and funding for early stage device projects;

  • Lead and collaborate on project planning and budgeting activities in support of successful tech transfer to product development group

  • Lead and participate in strategy sessions to develop multi-generational device plans that meet delivery requirements for Shire’s drug products

  • Be sought out by others as an expert in drug delivery and combination product integration;

  • Provide device/drug-delivery support to business development due diligences;

  • Monitor market and competitive intelligence for impact on device strategy;

  • Identify development partners/suppliers and nurture relationships through contracting;

  • Ensure work and team activities are aligned with all relevant quality, regulatory, HSE, GLP, and GMP requirements.

Responsibilities

Job Function and Description - % of Time

50% Identification and assessment of emerging drug delivery technologies

10% Supplier partnership development

15% Support to business development due diligence

25% Project business case and TDP development

Education and Experience Requirements

Education:

  • BS/BEng in relevant engineering or scientific area of study (typically, mechanical or biomedical engineering) with minimum ten (10) years’ experience in Medical Device development.

  • Or MS in relevant engineering or scientific area of study (typically, mechanical or biomedical engineering) with minimum eight (8) years’ experience in Medical Device development.

  • Experience in medical device development and application of Design Controls and Risk Management

Preferred:

  • Experience with combination products;

  • Demonstrated experience in performing technology assessments (typically supporting due diligence activities);

Drug (small molecule and/or biologic) delivery experience

Key Skills, Abilities, and Competencies

  • Has demonstrated expertise in medical device design and application of Design Controls and Risk Management;

  • Has an understanding of system level considerations for drug delivery device development (primary drug packaging, filling, and drug compatibility);

  • Is able to critically evaluate opportunities and assess risks;

  • Is able to work collaboratively;

  • Has excellent written and oral communication skills; is able to tailor communications for the audience; can communicate complex topics to a lay audience;

  • Is able to think creatively and offer solutions that may not be obvious;

  • Is able to influence decision-making;

  • Understands how user needs drive requirements;

  • Is able to estimate activities and resources required to support a project;

  • Takes initiative and is able to progress activities with minimum of oversight.

Complexity and Problem Solving

The incumbent will recommend potential technologies and potential development partners, and in conjunction with commercial, develop business cases to support project approval and entry to the next stage of development. The incumbent will work, under confidentiality, with business due diligence teams.

Internal and External Contacts

Internal:

COM - Commercial; DD – Device Development engineering; drug Program Leads (GDL/PSL); Program Managers (RDPM/PSPM); DCL – Device Clinical Lead; Medical Device Mgmt; Drug product experts; Procurement/Supplier Management

Vendor:

Consulting companies; development partners; device suppliers

Customer:

Internal customers as noted above

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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Reasonable Accommodations

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.