Clinical Scientific Program Lead

Vor 2 Tagen

Wedel, Deutschland medac Gesellschaft für klinische Spezialpräparate Vollzeit

vom:

- medac ist ein zukunftsgerichtetes, seit über fünfzig Jahren dynamisch wachsendes Unternehmen. Über 2.000 Mitarbeiter kümmern sich um die Neu
- und Weiterentwicklung von Arzneimitteln und Medizinprodukten für die Diagnostik und Behandlung onkologischer, urologischer und Autoimmunerkrankungen. Insbesondere bei Nischenprodukten zählen wir zu den führenden Pharmaunternehmen.
- Acts as global clinical program lead, overseeing multiple trials in a clinical development program
- Leads the clinical program team being accountable for excellence in clinical trial strategy and leadership for design, execution and reporting ensuring high quality data
Supervises the planning and proactive management of clinical program(s)
- Undertakes product and therapeutic area reviews and provides evidence-based medical and scientific input to trial-related, strategic and regulatory documents
- Is accountable for delivering the medical aspects of the clinical development plans and TPPs
- Contributes to the core medical/scientific information required in all clinical documents (e.g. study protocols, clinical trial reports, safety related documents) and assures preparation of high quality documents
- Contributes to development of publication plans in collaboration with other internal departments
- Provides clinical and scientific oversight for assigned clinical development programs, including medical monitoring across multiple clinical trials in collobaration with qualified in
- or external persons
- Supports the evaluation of potential clinical development projects for in
- or out licensing purposes and other departments with clinical and scientific input, if required
- University Degree in Lifescience required, Medical Degree preferred
- At least 5 years’ international experience in Clinical Research Phase I-III
- Highly productive and well organized regulatory writer
- Experience in strategic planning, executing and designing of Clinical Development Plans and trial protocols
- Experience with regulatory interactions gained during previous submissions to EMA, FDA or PMDA
- Firm knowledge of GCP/ICH rules and relevant laws and regulations
- Team player with strong communication skills
- Excellent analytical skills combined with a strategic vision
- Language: Fluent English, some German preferred

Wenn Sie eine neue berufliche Herausforderung und eine zukunftsorientierte Aufgabe suchen, freuen wir uns auf Ihre Online-Bewerbung mit Angabe Ihres frühestmöglichen Eintrittstermins und Ihrer Gehaltsvorstellung. Hierfür steht Ihnen unser Online-Bewerbungsformular auf medac.de zur Verfügung. Bitte beachten Sie, dass Bewerbungsunterlagen nicht zurückgeschickt werden können.

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