Clinical Development Manager (f/m/d)

AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care. To enhance our team in Vienna we are looking for a:

In this role, you will play a key part in shaping and executing clinical development strategies across early and late-stage programs, integrating translational insights and contributing to innovative therapeutic solutions in AOP Health´s core therapeutic areas.

• Support the translational strategy across programs by integrating nonclinical, biomarker, and clinical insights to drive data-informed development decisions.
• Contribute to the Target Product Profile (TPP) and Clinical Development Plan (CDP), ensuring alignment with translational and clinical strategies.
• Lead or contribute to the design, synopsis, protocol, amendments, and final reports for clinical studies.
• Analyze clinical and translational data to evaluate target engagement, mechanism validation, and early efficacy signals.
• Coordinate internal and external activities, including collaborations with CROs, to optimize compound selection and explore therapeutic potential.
• Author and review clinical and regulatory documents, including ODD applications, eCTD clinical sections, and briefing materials for scientific advice meetings.
• Prepare and deliver scientific presentations for internal and external audiences, including publications and conferences.
• Collaborate cross-functionally to assess in-licensing opportunities and new therapeutic targets.
• Maintain up-to-date knowledge of developments in clinical pharmacology, therapeutics, regulatory science, and pharmaceutical medicine, by actively engaging with relevant literature, congresses, and workshops.
• Contribute to the creation and revision of Standard Operating Procedures (SOPs) to ensure compliance and efficiency.

• University degree in natural sciences or medicine.
• Minimum 3 years of experience in clinical development (CRO or sponsor), ideally involving clinical study design, biostatistics, and data interpretation, with a strong foundation in translational medicine.
• Alternatively, PhD/Postdoctoral experience (≥5 years) in a relevant therapeutic area with a strong scientific background in translational medicine.
• Demonstrated experience in scientific writing and communication, ideally including medical writing of protocols, study reports, publications, and regulatory documents.
• Solid understanding of Good Clinical Practice (GCP) guidelines.
• Excellent communication and presentation skills in English.
• Proficient in Microsoft Office 365 and Adobe Acrobat.

• An open corporate culture with the opportunity to contribute your own ideas
• Working independently in a collegial and committed team
• Modern working environment with good public transport connections (U4 - Heiligenstadt)
• Flexible working hours (flexitime/time-out days), bonus scheme, additional benefits and employee events
• Structured onboarding and support through a buddy system
• Due to legal requirements, we are obliged to disclose the collective agreement minimum salary, which is EUR 66,472 gross per year, based on full-time employment. However, our actual remuneration packages are market-oriented and aligned with your qualifications and professional experience.