Device Development Project Leader

6 days ago

Dublin, Dublin City, Ireland beBee Careers Full time €91,185 - €124,570
Program Manager - Drug Delivery Device Development

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We are seeking a seasoned Program Manager to lead cross-functional teams in the development and delivery of robust and high-quality injectable drug-device technologies.


Why this role?
  • Be part of a diverse, inclusive and authentic workplace that offers competitive salaries, benefits & career progression opportunities.
  • Work on projects that contribute to creating healthier communities worldwide through education, outreach and better access to treatment.

Job Responsibilities:

  1. 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.
  2. Generate and maintain project plans, resource forecasts, technical & business risk registers, and proactively use knowledge and information to communicate with peers to enable program execution.
  3. Lead internal/external partners to identify opportunities and solutions to enable the development programme to maintain on-track to plan.
  4. Manage schedule conflict issues and resource peaks/troughs, and escalate to stakeholders in a timely fashion.
  5. Lead 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.
  6. Develop and implement integrated project risk management plans.
  7. Provide timely reporting to the programme team members, alerting them to potential endangered milestones, missed deadlines, and critical path activities.
  8. Proactive planning of all activities within the development team to ensure engagement of team members in delivering the right content, quality, and timing.
  9. Promote a positive and engaged Quality Management System (QMS) and Environmental Health and Safety (EHS) culture.
  10. Other duties as assigned.

Requirements:

  • Degree in pharmaceutical science or engineering, or equivalent. MSc, PhD, or MBA is desirable.
  • Proven track record of managing programs and leading complex cross-functional teams in the biotechnology or pharmaceutical industry.
  • Experience 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 technical and project discussions with technical teams and stakeholders.
  • Experience working with external partners, such as Contract Manufacturing Organizations (CMOs).
  • Proficient user of project management planning software and experienced in using project management methodologies.
  • Knowledge of drug delivery technologies, including pen injectors, autoinjectors, vial kits, inhaler technologies, and prefilled syringes.
  • Understanding of industry standards applicable to drug delivery and medical device development, including ISO , ISO , and 21CFR Part .

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