Clinical Development Manager

Vor 2 Tagen

Wien W, Österreich AOP Orphan Pharmaceuticals Vollzeit

Full-time

Vienna

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.

If you would like to work as a team player in an international environment and can identify with our values "Agile, Ambitious, Aligned, Accountable and Appreciative", then: Take this CHANCE and

APPLY NOW

Please submit your application exclusively via the application link.

Introduction
Main Benefits

Bonus

Homeoffice

Flexible working hours

Initial and continuing education

Canteen

Good transport connection

Employee events

Meal allowance

Company doctor

Parking spot

Healthmeasures

Your Contact

Angelika Drabek

Manager Talent Acquisition

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