Manager, Device Program Lead

Team Horizon is seeking a Manager, Device Program Lead for our global client based in Dublin. In this role you will ensure 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.
 
Why you should apply:

• Join a company who are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.


• Be part of a diverse, inclusive and authentic workplace that offer competitive salaries, benefits & career progression opportunities

 
What you will be doing:

• Accountable for the provision of technical project management to Global Device Development programs to deliver end to end program management (concept generation through registration and launch) for drug delivery device programs, within agreed budget spend, and time constraints, aligned with client business plans.


• Generate & maintain projects plans, resource forecasts, technical & business risk registers and proactively use knowledge and information to communicate with peers to enable program execution


• Leads Internal/External Partners to identify opportunities and solutions to enable the development programme to maintain on-track to plan.


• Works with the team to manage schedule conflict issues and resource peaks/troughs, and where appropriate escalate to in a timely fashion.


• Leads project what-if scenario analyses (base, optimistic and pessimistic cases) based on information provided by members of the programme team to negotiate and reach agreement on a realistic, yet aggressive, plan or schedule.


• Leads the team in preparation, implementation and maintenance of integrated project risk management plan.


• Provides timely reporting to the programme team members, alerting them to the possibility of endangered/ missed or conflicting milestones, as well as critical path activities.


• Proactive planning of all activities within the development team to ensure engagement of team members in the delivery of the right content, of the right quality, at the right time.


• Actively promote a positive and engaged QMS and EH&S culture.


• Any other duties as assigned.

 
What you need to apply:

• Degree in a pharmaceutical science or engineering, or equivalent. MSc, PhD or MBA is desirable.


• 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).


• 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 and 21CFR Part 820.