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 Team Lead Clinical Development (f/m/d) / limited (min. 1 year).
In this role, you will lead a clinical development team, ensuring high performance and operational efficiency while aligning tasks with R&D goals. You will oversee trial design, regulatory documentation, and drug safety while supporting Clinical Operations and in-licensing evaluations.
What Your Day To Day Will Look Like
- Lead clinical development team, driving high performance standards and ensuring operational efficiency
- Guidance and supervision of direct reports with regards to project allocation, training and performance
- Define/adjusts group tasks and priorities to align with R&D/department goals
- Authoring of clinical development plans
- 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)
- Supporting Drug Safety with medical input in regard to SUSARs, SAEs, AEs, PSURs and DSURs
- Participate in the identification of potential investigational sites, overseeing and support of Clinical Operations
- Perform medical/safety review for clinical trials
- 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
- Identify new in-licensing opportunities by screening relevant literature and publications, as well as by attendance of appropriate meetings, congresses, seminars and workshops
Your Qualifications and Experience
- Medical doctor
- Minimum 5 years experience in global clinical development including US and EU territories of development
- Ideally experienced in early drug development (translational, Phase I/II)
- Experienced in medical writing of clinical documents (clinical study protocols, clinical study reports, publications, clinical sections of dossiers and regulatory documents)
- GCP knowledge or active certification
- Strong communication and presentation skills in English IT skills (Office 365, Adobe Acrobat)
Our Offer
- 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 5.000.- based on full-time employment (38,5h/week). Any potential overpayment depends on professional experience and qualifications.
