Global Head of Medical Affairs

About the Role

As Head of Medical Affairs, you will be responsible for maximizing Aerogen's global scientific leadership in aerosol drug delivery through medical strategy, evidence generation, scientific communication, and stakeholder engagement.

As a member of the senior leadership team, you will lead and develop a high performing global Medical Affairs and Medical Science Liaison team, driving clinical excellence, supporting commercial growth, and improving patient outcomes worldwide.

This is a unique opportunity to shape global clinical practice, influence product strategy, and play a key role in Aerogen's continued growth and innovation.

Key Responsibilities

1. Global Evidence Strategy Development and Execution
   • Work with key KOLs to identify areas of unmet medical need where Aerogen VBM evidence is required or could be strengthened to support inclusion in local, regional, national and global guidelines.
   • Define and prioritize the clinical evidence generation roadmap across QIP, RWE, IIT and RCT programmes.
   • Lead the design, development and implementation of high quality investigator initiated studies from ideation through to presentation, publication and evidence dissemination.
   • Ensure evidence generation supports clinical adoption, guideline inclusion, value demonstration and business priorities.
2. Medical Marketing Strategy and Implementation
   • Provide medical oversight and support for claims, promotional materials and scientific communications.
   • Develop clinical summaries, evidence based messaging and medical content for internal and external stakeholders.
   • Provide training support for internal teams, distributor partners and healthcare professionals.
   • Support KOL speaker programmes, MSL peer to peer communications and clinical education initiatives.
   • Ensure consistency, scientific accuracy and compliance across all medical communication activities.
3. MSL Excellence - including KOL engagement and advocacy, skills/capability and local execution
   • Build and lead a high performing MSL organisation that delivers impactful scientific engagement and insights.
   • Manage KOL engagement and relationship management, including targeting, tracking and reporting.
   • Facilitate scientific exchange and peer to peer engagement activities.
   • Generate and communicate insights and competitive intelligence.
   • Provide effective training, coaching and capability development.
   • Drive MSL innovation, best practice sharing and external benchmarking.
   • Ensure compliance, documentation, pharmacovigilance and support for in field off label enquiries.
4. Clinical Affairs - regulatory compliance, data leverage and input to NPD clinical evidence
   • Deliver relevant clinical data development and leverage strategies for existing and new products.
   • Handle clinical safety, efficacy, technical and off label queries directly with clinicians.
   • Provide clinical input into applications for new product approvals and changes to existing products.
   • Develop Clinical Evaluation Reports (CERs) and evaluate relevant clinical research and publications across the aerosol market.
   • Manage safety and adverse event interactions with HCPs, including post market surveillance and regulatory reporting.
   • Ensure all promotional claims and materials are supported by valid clinical evidence and compliant with applicable codes, regulations and standards.
   • Provide clinical input into new product development and future evidence requirements.
5. Organisation and Team Development
   • Attract, retain, develop, coach and manage performance of a highly engaged and high performing team.
   • Develop and progress the Aerogen Medical Affairs Academy.
   • Establish investment priorities and manage the Clinical Affairs budget through strategy, budget, quarterly and monthly planning processes.
   • Contribute to company wide business operations through active participation in the Senior Leadership Team.
   • Provide leadership and cross functional collaboration as a core contributor to Aerogen's Global MLT and wider leadership team.
   • Act as a role model for and actively reinforce Aerogen's Culture and Values within and beyond the Medical Affairs organisation.

Education & Experience

• Qualified physician or senior healthcare professional (preferably with acute medicine, respiratory, intensive care, or critical care experience), or a PhD with significant Medical Affairs leadership experience.
• Proven track record of designing and delivering global clinical evidence generation programmes within the medical device, pharmaceutical, or healthcare sectors.
• Extensive experience working directly with commercial teams across the US, Europe, and Asia-Pacific.
• Demonstrated success in building and managing high performing international teams.
• Strong experience engaging with KOLs, investigators, and external medical experts.
• Experience developing and implementing global clinical trial programmes that address market and business needs.
• Experience within the medical device industry is strongly preferred.

Key Skills

• Strong desire and ability to collaborate proactively and constructively with Commercial, Marketing, Regulatory, Clinical, and R&D teams, with a focus on driving business growth.
• Proven leadership and organisational skills, with experience building, developing, and managing high performing international teams.
• Experience within the medical device sector, with an understanding of international medical device regulatory frameworks.
• Demonstrable track record of building and maintaining strong relationships with Key Opinion Leaders as part of a global advocacy programme.
• Experience reviewing and editing clinical and regulatory documentation and working with external medical experts.
• Strong understanding of FDA regulations, Medical Devices Codes of Practice, and promotional material review and approval processes.
• Excellent clinical data analysis, interpretation, and evidence evaluation skills.
• Experience reviewing medical publications and editing scientific manuscripts.
• Strong attention to detail and commitment to scientific excellence.
• Outstanding written and verbal communication skills, with experience presenting at international congresses and scientific meetings.
• Budget management experience with a focus on delivering strategic value and return on investment.

Benefits

• Excellent medical care.
• Bonus & pension.
• Opportunities for development and professional growth.
• Aerogen Connect - an employee led program that helps our global teams unite and have fun.
• Donation of 1% of profits and time to charities and organisations.

Aerogen is committed to promoting diversity, inclusion, and equality in the workplace.