Clinical Affairs Manager

About Aerogen

Headquartered in Galway, Ireland, Aerogen is a global leader in acute care aerosol drug delivery, operating in more than 80 countries. The company has received numerous MedTech awards and is committed to improving patient care through innovation and collaboration across a diverse, international team.

What is the role?

This position leads Aerogen's Clinical Affairs Team to develop and implement clinical data strategies for existing and new products, supporting marketing, medical affairs and regulatory teams to ensure safety, compliance, pharmacovigilance and evidence-based claims.

Key responsibilities

• Lead proactive, end-to-end management of clinical and post market regulatory deliverables to support global clinical evaluation requirements (prioritising FDA/MDD/MDR P1 and key P2 markets), including:
  • Design, execution and maintenance of pre and post market clinical assessment strategies, leveraging Aerogen's Global Evidence Programme and, where required, additional clinical investigations and related evidence generation activities
  • Clinical Evaluation Plans and Reports (CEP/CER)
  • PMCF plans and activities
  • PSUR contributions
  • Device safety vigilance / adverse event reporting
  • Coordination and consultation of expert external clinical stakeholders, including KOLs
• Work closely with regulatory, quality and manufacturing teams to manage and coordinate effective clinical assessment, including external expert/KOL consultation and response to nonconformance, complaints, adverse event reporting and quality concerns.
• Collaborate with Medical Affairs and Evidence Strategy and Operations to support clinical needs assessment and planning for new evidence generation, overseeing existing studies, evaluating new study proposals and generating insight during and after study completion; lead review and approval of documentation for clinical studies in compliance with regulatory requirements and quality standards.
• Support marketing and medical affairs teams in maximising promotional claims, including meta analysis and publication of consolidated claim data.
• Partner with marketing and R&D teams on clinical data strategies for new product and lifecycle programmes.
• Maintain the MA database for HCP enquiries, including requests for off label information, safety or quality issues in general use and clinical trials:
• Provide quarterly post marketing surveillance reviews
• Ensure the latest clinical evidence is reflected in both on and off label Medical Information requests and responses
• Recruit, develop, coach and manage a high performing Clinical Affairs team.
• Establish and manage a prioritised investment plan and team budget through strategy, budget, quarterly and monthly processes.
• Provide effective leadership and collaboration as a core contributor to Aerogen's Global MLT and broader leadership team.
• Act as a role model, reinforcing Aerogen's culture and values within and beyond the Medical Affairs Team.

Required education and experience

• Life sciences degree or medical qualification (PhD, MD or PharmD with a medical/clinical focus preferred).
• 5 10 years of hands on relevant medical device or pharmaceutical and/or Medical / Clinical Affairs experience, preferably in respiratory or critical care.
• Expertise in medical or technical writing in academia or the pharma/medical device industry.
• Expertise interpreting clinical/scientific research data and correlating experimental to theoretical results, with knowledge of analytical/statistical models.
• Project and people management experience.
• ISO 14155:2020 certification preferred.
• Detailed knowledge of regulatory requirements, guidelines, ethical standards and industry best practices relevant to the role.
• Strong clinical evaluation assessment and medical writing skills, including familiarity with ICMJE recommendations and guidance for CE marketed documents such as CERs.
• Strong attention to detail, logical thinking, and the ability to interpret complex clinical data, identify patterns and devise solutions.
• Experience in assessment, design, execution and leverage of data from clinical trials.
• Detailed knowledge of biostatistics and ability to analyse and critique clinical data.
• Ability to understand, critically assess and utilise multiple data sources, including AI tools to maximise efficiency and effectiveness of data management and medical writing.
• Strong presentation, communication and influencing skills with the capacity to adapt messaging for varied audiences, including clinical KOLs and regulatory experts.
• Strong collaboration skills with cross functional teams and external stakeholders.
• Capability to recruit, retain and develop teams, aligning resources and budgets while managing workload and staff motivation.
• Self motivated, capable of independent work within multidisciplinary external and internal teams.
• High personal and professional standards, with a drive for continuous improvement.
• Approximately 15% travel required to engage field teams and stay current with industry practices.
• Preferred location: Aerogen's headquarters in Galway, given the cross functional nature and leadership component of the role.

Key skills

• Strong clinical evaluation assessment and medical writing skills, knowledge of ICMJE guidance for CE marketed documents such as CERs.
• Strong attention to detail, logical thinking, ability to interpret complex data, recognise patterns and devise solutions.
• Experience in assessment, design, execution and leverage of data from clinical trials.
• Detailed knowledge of biostatistics and capability to analyse and critique data.
• Ability to understand and utilise multiple data sources, including AI tools, to enhance data management and medical writing.
• Excellent presentation, communication and influencing skills, adapting messaging for diverse audiences including KOLs and regulators.
• High collaboration ability across cross functional teams and external stakeholders.
• Capability to recruit, retain and develop teams, prioritise resources and manage budgets while balancing workload and motivation.
• Self motivated and able to work independently in multidisciplinary settings.
• Commitment to high professional standards and continuous personal development.
• Willingness to travel 15% to support clinical evaluation and stakeholder engagement.
• Preferred location: Aerogen's headquarters in Galway, due to the role's cross functional and leadership requirements.

Benefits

• Competitive bonus plan
• Above market life insurance
• Opportunities for professional growth and development
• Employee led program 'Aerogen Connect' to unite teams and provide social events
• 1% donation of profits and time to charities and organizations

EEO Statement

Aerogen is committed to promoting diversity, inclusion, and equality in the workplace. If you have difficulty using our application process, please contact us via email at . Please provide your name and preferred contact method.