McDermott Laboratories Limited
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
The Role & What You Will Be Doing
Every day, we rise to the challenge to make a difference and here’s how the Director, Device User Interface role will make an impact:
Team Leadership
Leads a high performing team in the successful translation of user needs, use scenarios, and use-related risks into robust, traceable design inputs, fully integrated with the agreed program plans for the Design Input and Output stages of device development lifecycle.
In conjunction with Senior Director, User Interface, guide the execution of end-to-end Human Factors activities across the development lifecycle from early formative evaluations at program initiation to Validation activities including Summative HF studies, Comparative Analysis and Comparative Use HF studies.
Leads the team in the execution of programs, ensuring comprehensive evaluation of methodology, identification of improvements and stakeholder acceptability.
Champion continuous improvement in User Interface processes, tools, and governance to enhance development efficiency and compliance.
Mentors and develops a high performing team, providing leadership and expertise whilst strengthening capability in usability engineering, regulatory strategy, and risk-based decision-making.
Fosters a culture of innovation, collaboration, and continuous improvement. Ensures the personal, and professional growth and development of all colleagues within the team. Promotes a positive and engaged culture.
Establishes appropriate KPIs and provides timely reporting to the GDD leadership.
Portfolio Delivery
Contributes to strategy of the wider portfolio aligned with experiences and expertise.
Plans and monitors all activities within User Interface team to ensure engagement of team members in the delivery of the right content, of the right quality and at the right time.
Ensure portfolio alignment on the strategy for Comparative Analysis / Comparative Use Human Factors (CUHF) studies to demonstrate equivalence to Reference Listed Drug (RLD) in support of ANDA submissions.
Ensure portfolio alignment and close collaboration with key stakeholders on Human Factors program strategy for NCE development.
Technical Excellence
Guides the team to deliver the User interface strategy for medical devices, and drug-device combination products, ensuring alignment with regulatory strategy, compliance with the associated regulatory requirements, intuitive design, accessibility, and patient-centric usability.
Drives efficiency in documentation through standardisation, technology and trainings resulting in clear, right first time, inspection-ready User Interface documentation.
Drives team innovation in device design by identifying emerging trends, new technologies, and industry best practices.
Contributes to global device and business strategy and continuous improvement to the operational delivery of the high performing teams.
Contribute to consistent, high value UI engagement with regulators (FDA, EMA, Notified Bodies etc.) securing alignment on usability and validation strategy.
Drives the team in the execution of all aspects of user risk management ensuring compliance to ISO14971 and alignment with the overarching GDD Risk Management File.
Support Senior Director, User Interface in the maintenance of close partnerships with relevant global business owners and GDD Functional Lines, ensuring collaborative engagement with key stakeholders and establishing advocates in stakeholder teams.
Partner cross-functionally with Device Design, Clinical, Regulatory Affairs, and Quality to embed user-centric design into device development.
Represents the company externally as required.
Oversee external vendors and study execution, ensuring methodological rigor, compliance, and timely delivery of Human Factors evidence.
About Your Skills & Experience
For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
Essential
Degree in a Pharmaceutical Science, Medical Device/Product Design, or equivalent.
Proven experience in Pharmaceutical Development, Human Factors Engineering or Medical Device/Combination Product Engineering, with at least 5 in a leadership role.
Proven track record of leading development strategy and program execution.
Well-developed oral and written communication skills.
Experience of working with external partners.
Experience of project management.
Knowledge of drug delivery technologies, e.g. pen injectors, autoinjectors, vial kits, inhaler technologies, and prefilled syringes.
Detailed knowledge of the requirements of key industry standards, as applicable to drug delivery and medical device development, including EU MDR, ISO 13485, ISO 14971, ISO 62366 and 21CFR Part 820.
Desirable
MSc, PhD or MBA is desirable.
Knowledge of Medical Device/Combination Product design control activities with integrated risk management deliverables and human factors/usability engineering studies, from project initiation to product launch.
Significant experience of drug delivery device / system design.
Experience of both NCE and Generic product development with a demonstrable understanding of the different regulatory pathways and requirements.
Previous experience in provision of submission/filing sections against drug delivery systems for regulatory agencies.
At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Benefits at Viatris
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.
