Clinical Affairs Manager / Senior Manager

About Aerogen:

Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards, including being named Galway Chamber Company of the Year 2025, and an eleven-time winner of the Zenith Award for Respiratory Care Excellence in North America, our employees make a difference to patients’ lives every day, having reached over 30 million patients in more than 80 countries.

Today, Aerogen is powered by a global team representing 54 nationalities, working together with a shared commitment to improving patient care. Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work.

We lead the way by finding innovative solutions to even the most complex problems, all in the name of delivering better patient outcomes.

Our business continues to grow rapidly across the globe and, as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours, and we are committed to supporting our employees to reach their full potential through tangible investment in their careers.

Join us as we continue to #discoverbetter.What is the role?

This role is responsible for leading Aerogen’s Clinical Affairs Team to deliver clinical data development & leverage strategies, and their implementation, for existing and new products, supporting Aerogen’s marketing, medical affairs and regulatory teams ensuring effective safety, compliance and pharmacovigilance along with optimizing labelling, medical information support and evidence based claims.

What are the key responsibilities?

1. To lead and ensure proactive, end-to-end management of Aerogen’s clinical and post-market regulatory deliverables to support global clinical evaluation requirements (prioritizing FDA/MDD/MDR P1 and key P2 markets) including :

a. 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

b. Clinical Evaluation Plans and Reports (CEP/CER)

c. PMCF plans and activities

d. PSUR contributions

e. Device safety vigilance/adverse event reporting.

f. Coordination and consultation of expert external clinical stakeholders including KOLs

2. Working closely with regulatory, quality and manufacturing teams managing and coordinating effective clinical assessment, including, where required external expert/KOL consultation, and response to nonconformance, complaints, adverse event reporting and quality concerns.

3. To work closely with Medical Affairs and Evidence Strategy and Operations Team to support clinical needs assessment and planning for new evidence generation including oversight of existing studies, assessment of new study proposals and insight and evidence generation during and after study completion. This includes lead review and approval 1) To lead and ensure proactive, end-to-end management of Aerogen’s clinical and post-market regulatory deliverables to support global clinical evaluation requirements (prioritizing FDA/MDD/MDR P1 and key P2 markets) including :

a. 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

b. Clinical Evaluation Plans and Reports (CEP/CER)

c. PMCF plans and activities

d. PSUR contributions

e. Device safety vigilance/adverse event reporting.

f. Coordination and consultation of expert external clinical stakeholders including KOLs

2. Working closely with regulatory, quality and manufacturing teams managing and coordinating effective clinical assessment, including, where required external expert/KOL consultation, and response to nonconformance, complaints, adverse event reporting and quality concerns.

3. To work closely with Medical Affairs and Evidence Strategy and Operations Team to support clinical needs assessment and planning for new evidence generation including oversight of existing studies, assessment of new study proposals and insight and evidence generation during and after study completion. This includes lead review and approval of, documentation for clinical studies, in compliance with regulatory requirements and quality standards.

4. To work closely with marketing and medical affairs teams to proactively support maximise leverage of promotional claims including meta-analysis and publication of consolidated claims data.

5. To work proactively with marketing and R+D teams on clinical data strategies for new product/lifecycle programmes.

6. Working with the medical affairs team to maintain the MA database for HCP enquiries including requests for off-label information, reported safety or quality issues in general use and in clinical trials and

a) provide quarterly post marketing surveillance reviews

b) ensure the latest clinical evidence is reflected in both on and off label Medical Information requests and responses

7. Effective recruitment, professional development, coaching and performance management to ensure a strongly engaged and high performing Clinical Affairs team.

8. To effectively establish a prioritized investment plan and manage Aerogen Clinical Affairs team budget through the strategy, budget, quarterly and monthly processes.

9. To provide effective leadership, collaboration be a core contributor to Aerogen’s Global MLT and wider Aerogen leadership team.

10. To act as a role model for and actively reinforce Aerogen’s Culture and Values within and beyond the Medical Affairs Team

What education and experience are required?

• Life sciences degree or medical qualification required. Job holder likely to also have PhD, MD or Pharm D with a Medical/Clinical focus.

• And/or, at least 5-10 years, hands-on relevant medical device/pharmaceutical and/or Medical / Clinical Affairs experience, preferably in respiratory or critical care.

• Expert medical and/or technical writing experience in academia or pharma/medical device industry.

• Expert ability to interpret clinical/scientific research data and correlate experimental to theoretical results, conversant with analytical/statistical models.

• Project and people management experience.

• ISO 14155:2020 certified is preferred.

• Detailed knowledge and familiarity with regulatory requirements, guidelines, ethical standards and industry best practices relevant to the position’s roles and responsibilities.

What key skills will make you great at the role?

• Strong clinical evaluation assessment and medical writing skills and knowledge of ICMJE recommendations and guidance and requirements for documents to support CE marketed medical documents e.g., CERs.

• Strong attention to detail, logical thinker with the ability to interpret complex clinical data, problems and identify patterns and solution with ability to resolve issues in an organized and analytical manner.

• Experience in assessment, design, execution and leverage of data from clinical trials strongly preferred.

• Detailed knowledge of biostatistics and ability to analyses and critique clinical data.

• Ability to understand, critically assess and utilize multiple data sources including leverage of AI tools to maximize efficiency and effectiveness of data management and medical writing.

• Strong presentation, communication and influencing skills combined with IQ/EQ to assess and adapt messaging/format/length/pace according to the audience including clinical KOLs and regulatory experts.

• Strong capability to effectively collaborate with cross-functional teams and external stakeholders

• Ability to recruit, retain and develop teams including assessing priorities and lead resource alignment including budget with an organised approach to handling a busy workload and manage staff workload, development and motivation.

• Self-motivated, extremely capable of working independently in a self-directed manner within the context of multidisciplinary external and internal teams.

• High personal and professional standards with drive for personal development and continuous improvement.

• The role requires a certain amount of travel ~15% to ensure importance of clinical evaluation is understood by Aerogen’s field based teams, to proactively listen to customer feedback and to stay up to date with requirements and to network/assess best practice in clinical evaluation across the medical device industry.

• Given the key cross functional nature and the leadership component of this role the strongly preferred location for this role is Aerogen’s headquarters in Galway.

What is it like to work in Aerogen?

Our purpose is to transform patient lives and our ethos is to #discoverbetter. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non-financial rewards and benefits. There’s something for everyone! Here is an idea of what we offer:

• Competitive bonus plan.

• Above market life insurance.

• Opportunities for development and professional growth.

• "Aerogen Connect" – our employee-led program that helps our global teams unite and have fun.

• We donate 1% of profits and time to charities and organizations.

Visit our careers website for more information about life at Aerogen.

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 careers@aerogen.com. Please provide your name and preferred contact method.