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 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.

• 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

• University degree in Natural Sciences or Medicine
• Minimum 3 years of experience in clinical development (CRO or sponsor), ideally in designing clinical studies, biostatistics, interpretation of clinical data or research-related experience and strong scientific background in translational medicine or if transitioning from academia Phd/Post-doc with a minimum of 5 years of research in a relevant therapeutic area
• Experienced in science communication & writing ideally in medical writing of clinical documents (clinical study protocols, clinical study reports, publications, clinical sections of dossiers and regulatory documents)
• GCP knowledge
• Strong communication and presentation skills in English
• IT skills (Office 365, Adobe Acrobat)

• Open corporate culture with the opportunity to bring in your own ideas
• Great opportunities for personal and professional development
• Attractive work environment with excellent career opportunities and flat hierarchies
• Competitive salary package plus bonus and various benefits
• Gross monthly salary provided for this function is a minimum of EUR 4.500.- based on full-time employment (38,5h/week). Any potential overpayment depends on professional experience and qualifications.