Clinical Development Manager

Vor 2 Tagen

Wien, Wien, Österreich AOP Health Vollzeit € 66.472 - € 100.000 pro Jahr

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.

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