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 :

Clinical Development Manager (f / m / d)

1190 Vienna Vollzeit Start : as of now

In this role, you will drive the development and execution of clinical studies, provide medical and scientific expertise for regulatory submissions and drug safety, and support Clinical Operations. You will collaborate with internal and external stakeholders, assess new in-licensing opportunities, and stay updated on advancements in clinical research and regulatory affairs.

What Your Day To Day Will Look Like

• Development of design, synopsis, protocol, amendments, and final reports for clinical studies
• Authorship of clinical documents for regulatory purposes (ODD, clinical eCTD sections, Briefing Book for scientific advice)
• Provide medical / scientific advice required in clinical trials and regulatory documents
• Supporting Drug Safety with medical / scientific input in regard to SUSARs, SAEs, AEs, PSURs and DSURs
• Participate in the identification of potential investigational sites, overseeing and support of Clinical Operations
• Supporting Clinical Operations regarding medical questions during trial conduct
• Presentation of clinical data internal and external (incl. publications)
• Working with other functions in the assessment of new in-licensing opportunities in relevant therapeutic areas
• Maintain an awareness of new developments in clinical pharmacology, therapeutics, pre-clinical and laboratory testing, drug regulatory affairs and pharmaceutical medicine within our core therapeutic areas by screening the relevant literature and publications, as well as by attendance of appropriate meetings, congresses, seminars and workshops

Your  Qualifications and Experience

Our Offer

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 :