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Clinical development manager (f/m/d)

Klosterneuburg
Festanstellung
AOP Health
Development Manager
€ 70.000 pro Jahr
Inserat online seit: 10 Dezember
Beschreibung

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.


What Your Day To Day Will Look Like

* 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.


Your Qualifications and Experience

* 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.


Our Offer

* 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.


Main Benefits

* Bonus
* Homeoffice
* Company car
* Employee mobile phone
* Flexible working hours
* Laptop
* Initial and continuing education
* Canteen
* Good transport connection
* Employee events
* Meal allowance
* Company doctor
* Parking spot
* Health measures
* Employee discount


Your Contact

Angelika Drabek
Manager Talent Acquisition

Further information on our website:

#J-18808-Ljbffr

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