Global Clinical Leader Ophthalmology
Your tasks and responsibilities
The Global Clinical Leader (GCL) is responsible for all strategic (phase Ib-III) and operational clinical activities in the context of a development program in the field of Ophthalmology. This includes late stage development projects (phase Ib - III) or clinical life-cycle management activities for marketed products. The Global Clinical Leader also provides guidance to early, pre-POC assets in preparation for declaration of Proof of Concept. The responsibility of a Global Clinical Leader can consist of parts (e.g., individual indications) or an entire clinical program. As such, the GCL is a member of the Global Program Team and leads the Clinical Team cross functionally. The location of this position can be either in Germany (Berlin) or Switzerland (Basel).
- Leads the Clinical Team, a cross functional, multinational team of internal experts, sets project-related objectives with Clinical Team members and provides input to their annual performance evaluation
- In consultation with relevant key disciplines, prepares the Clinical Development Plan (CDP), responsible for planning and managing the clinical timelines, managing clinical budget (external clinical grants and CRO management fees) and manpower against the approved CDP and approved resources
- Responsible for the ongoing risk-benefit assessment of a compound until approval in a main country. Analyses incoming clinical data, relevant medical and scientific information and initiates actions or decisions as appropriate
- In consultation with the Global Project Head (GPH) and with the Clinical Group Head, is responsible for communication of medical project and study strategy, study results and clinical project results to internal and external bodies (e.g. regulatory authorities). Prepares assessments and recommendations at Decision Points, and presents them together with the GPH
- Responsible for defining the strategic approach and managing preparation of medical sections of key Regulatory documents (Integrated Summary of Efficacy, Integrated Summary of Safety, expert reports, Core Benefit-Risk Assesment (CoBRA). Compiles and maintains Investigators’ Brochures (IB).
- Provides medical expertise to Global Strategic Marketing (for marketed products) and Strategic New Product Marketing (for development projects) and contributes to the publication strategy. Approves publications and ensures consistency of publications with clinical data and publication strategy
- Establishes and maintains appropriate external scientific advisory boards and assists in advocacy development
- Provides medical assessment of in- and out-licensing opportunities of development projects
Who you are
- Successful M.D. with extensive professional and academic experience. Board certification in Ophthalmology is preferred.
- In-depth understanding of the drug development and commercialization process with a base of experience of 3-5+ years in Medical Science and drug development (from protocol writing to Clinical Study Report) (which may include relevant academic and/or clinical experience).
- Strong project management skills
- Great communication skills
- Excellent networking abilities with internal and external stakeholders
- Ability to effectively work in an international and multicultural environment
- Decisive and well developed practical judgment
- Good emotional skills and personal insights
- Fluency in English, any other language is highly desirable
Functional Area: [sap_fa_16]
Entry Level: 5