Director, Device Program Lead

Viatris; Dublin; On-site; EUR 110,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Bonus scheme

Pension

Diversity & Inclusion

Work-life balance

Job summary

Viatris seeks a Director, Device Project Management to lead cross-functional teams in the development and transfer of injectable drug-device technologies (autoinjector, prefilled pen, PFS, vial-kit).

You will drive strategic direction, manage milestones, risks, budgets and resources, mentor program leads, and collaborate with global device development teams to ensure timely delivery of robust device CMC programs for global registrations.

Qualifications

• Degree in a pharmaceutical science or engineering, or equivalent.
• MSc, PhD or MBA is desirable.
• 10+ years experience in medical device or combination product engineering, with at least 5 in a leadership role.
• Proven track record of managing programs and leading complex cross functional program teams.
• Experience of leading a drug delivery device programme through development to product scale-up and launch.

Responsibilities

• Provide technical program management leadership during the development and transfer of injectables products.
• Develop and execute strategic workplan for the Injectables Portfolio.
• Drive progress of allocated programs, developing a holistic summary of key milestones, program risks, budget and resource.
• Lead and mentor Program Leads on the development of Combination Products.
• Deliver technical project plans linked goals on time and within resource and expenditure budgets.

Skills

Program management

Cross-functional leadership

Stakeholder management

Communication skills

Leadership

Education

Bachelor's degree in pharmaceutical science or engineering

MSc/PhD/MBA desirable

Tools

MSP

Job description

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 approximately1billion 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.

Role & What You Will Be Doing

Project Management using advanced program management skills to lead cross-functional teams in the development and delivery of robust and high-quality injectable drug-device technologies. The role may span multiple technologies including include autoinjector, prefilled pen, PFS and vial-kit device programs. Every day, we rise to the challenge to make a difference and here’s how the Director, Device Project Management role will make an impact: Provide technical program management leadership and expertise during the development and transfer of injectables products. Contribute to strategic direction and executable workplan for the Injectables Portfolio. Drive progress of allocated programs, developing a holistic summary of key milestones, program risks, budget and resource. Ensure the personal, and professional growth and development of all colleagues within the team. Lead and mentor Program Leads on the development of Combination Products. Deliver technical project plans linked goals on time and within agreed resource and expenditure budgets. Generate portfolio views based on project plans and ensure appropriate flow of information to all levels of GDD. Coordinates and drives the team to deliver prospective plans and resolve technical challenges, with appropriate deep Dives aligned to milestones and project timelines to meet/or exceed key milestones and decision points with a full understanding of critical path activities. Partner with cross functional teams across global device development, and other team members in partner organisations, to ensure delivery of integrated project plans. Review/approves/author design review report, design & development plans where appropriate and support is needed. Leads the team to manage schedule conflict issues and resource peaks/throughs and where appropriate escalated to in a timely fashion. Drives the team to deliver to project timelines to meet/exceed key milestones, decision points with a full understanding of critical path activities. Provides timely reporting to the global leadership, alerting them to the possibility of endangered, missed or conflicting milestones as well as critical path activities. Establish, in partnership with relevant global business owners (e.g., development, commercial and supply/sourcing teams), appropriate representation on steering committees to ensure strategy, delivery and approach is aligned with Viatris submission and launch planning. Contribute to strategy developed across global functions to support delivery of a robust device CMC program for global registrations within an appropriately risk-managed but aggressive timeline. Contribute to strategic and technical elements of the wider portfolio aligned with experiences and technical expertise Proactive planning in all activities withing group and across GDD to ensure engagement of team members in the delivery of the right content, of the right quality and at the right time. Actively promote a positive and engaged QMS and EH&S culture. Responsible to contribute to global device and business strategy and continuous improvement to the operational delivery of the high performing teams.

• Provide technical program management leadership and expertise during the development and transfer of injectables products.
• Contribute to strategic direction and executable workplan for the Injectables Portfolio.
• Drive progress of allocated programs, developing a holistic summary of key milestones, program risks, budget and resource.
• Ensure the personal, and professional growth and development of all colleagues within the team.
• Lead and mentor Program Leads on the development of Combination Products.
• Deliver technical project plans linked goals on time and within agreed resource and expenditure budgets.
• Generate portfolio views based on project plans and ensure appropriate flow of information to all levels of GDD.
• Coordinates and drives the team to deliver prospective plans and resolve technical challenges, with appropriate deep Dives aligned to milestones and project timelines to meet/or exceed key milestones and decision points with a full understanding of critical path activities.
• Partner with cross functional teams across global device development, and other team members in partner organisations, to ensure delivery of integrated project plans.
• Review/approves/author design review report, design & development plans where appropriate and support is needed.
• Leads the team to manage schedule conflict issues and resource peaks/throughs and where appropriate escalated to in a timely fashion.
• Drives the team to deliver to project timelines to meet/exceed key milestones, decision points with a full understanding of critical path activities.
• Provides timely reporting to the global leadership, alerting them to the possibility of endangered, missed or conflicting milestones as well as critical path activities.
• Establish, in partnership with relevant global business owners (e.g., development, commercial and supply/sourcing teams), appropriate representation on steering committees to ensure strategy, delivery and approach is aligned with Viatris submission and launch planning.
• Contribute to strategy developed across global functions to support delivery of a robust device CMC program for global registrations within an appropriately risk-managed but aggressive timeline.
• Contribute to strategic and technical elements of the wider portfolio aligned with experiences and technical expertise.
• Proactive planning in all activities withing group and across GDD to ensure engagement of team members in the delivery of the right content, of the right quality and at the right time.
• Actively promote a positive and engaged QMS and EH&S culture.
• Responsible to contribute to global device and business strategy and continuous improvement to the operational delivery of the high performing teams.

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:

• Degree in a pharmaceutical science or engineering, or equivalent.
• MSc, PhD or MBA is desirable.
• More than 10 years experience in medical device or combination product engineering, with at least 5 in a leadership role.
• Proven track record of managing programs and leading complex cross functional program teams, in the biotechnology or pharmaceutical industry.
• Experience of working across the full project development cycle, from discovery / in-licensing through to registration, launch and post-market support.
• Well-developed oral and written communication skills to lead or facilitate effective technical and project discussions with technical teams and stakeholders.
• Experience of working with external partners (CMO’s).
• 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.
• Proficient user of project management planning software (MSP), and able to demonstrate experience of using project management methodologies (resource management, risk management, budget management etc)
• Experience of leading a drug delivery device programme through development to product scale-up and launch.
• Knowledge of drug delivery technologies, e.g. pen injectors, autoinjectors, vial kits, inhaler technologies, and prefilled syringes.
• Application and understanding of the requirements of key industry standards, as applicable to drug delivery and medical device development, including ISO 13485, ISO 14971, ISO 11608, ISO 11040 and 21CFR Part 820.

Benefits at Viatris

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension
• Diversity & Inclusion at Viatris

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. Viatris is a global healthcare company whose mission is to empower people worldwide to live healthier at every stage of life. We meet the needs of patients around the world by acting decisively with ingenuity and resolve. Whether we’re developing new medicines, working to maintain a resilient supply of needed therapies, or pursuing bold innovation, we strive to deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a broad portfolio that spans generics, value-added medicines, established brands, and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai, and Hyderabad, India.