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| Medical Director-Neurology |
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To develop and propose clinical and when appropriate business development strategy for the assigned area of expertise within Neurology Clinical Development Unit (CDU). To design direct and execute clinical development programs (phase II, III) in the assigned area of expertise for worldwide registration, to perform due diligence for in-licensing opportunities and to provide scientific support/input to early development projects and phase IIIb/IV Clinical Development plans, launch and post launch activities including key opinion leaders (KoL) development, within the scope of the CDU. Support medical communication in defining the communication strategy for products in the assigned area of expertise.
Develop and propose clinical and when appropriate business development strategy in the assigned area within the Neurology CDU. Support business development by identifying and evaluating (through due diligence) business opportunities and by identifying and anticipating all industry market trends related to the assigned therapeutic area by attending conferences, establish / maintaining relationship with key opinion leaders etc.
Propose and develop clinical development plans for the assigned products in the Neurology CDU (with input from European, American and when relevant Japanese Health Authorities) to establish their safety and efficacy and to support registration and successful marketing of such products worldwide. These plans will be part of the overall Product Development Plan.
Provide scientific input to early projects (Phase I and Proof of Concept) under the responsibility of experimental medicine/Clinical Pharmacology.
Increase scientific knowledge in the CDU by organizing scientific development activities within the therapeutic area (TA), such as holding internal courses, inviting external speakers etc..
Support Medical Affairs and medical marketing activities, by providing specialist input in Phase IV clinical development Plans, pre and post launch activities, by attending conferences, contributing to the organization of symposia and KoL development activities
Author/write clinical section of the Common Technical Documentation and in particular Clinical overview and SCE / SCS (Summary of clinical efficacy and summary of clinical safety)
If needed, to act as medical leader in Clinical Development projects.
If needed, supervise implementation of specifically allocated clinical studies worldwide by being responsible for the Protocol, Investigator selections, Investigator brochure and study reports. Ensures high quality of studies completed in a timely fashion. |
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Medical degree
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5 years + |
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English : Speak / Write Fluently
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open-ended |
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unspecified |
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EU National |
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Geneva |
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M.D. specialized in Neurology (preferably with experience in Multiple Sclerosis) with at least 5-8 years experience in clinical research (phase I to IV). Experience in pharmaceutical (or preferably Biotech) product development at international level including interactions with Health authorities (Europe , US and possibly Japan). Working knowledge of GCP and ICH guidelines/practices.
Ability to work in a matrix environment. Excellent initiative and driven by the sense of the urgency
Strong communication skills (face-to-face, presentations, reports, etc.).
Good selling and influential skills. Strategic thinking. Project Management capabilities.
Entrepreneurial spirit and action/results driven. High-energy level person, motivator. Flexible
Willing to travel when necessary (up to 30% of the time). |
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Merck Serono is the division for innovative small molecules and biopharmaceuticals of Merck KGaA.
Merck Serono’s global headquarters are located in Geneva, Switzerland. |
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