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| Senior Medical Director Fertility |
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The incumbent is deputy head of Fertility and Rockland/Geneva site administrator who directs and coordinates global clinical development and Medical Affairs Fertility/Reproductive Health programs (phase II, III) for worldwide registration and provides subsequent scientific support, as directed by the Head of Clinical Development Unit. Also proposes clinical development plans for selected products to establish their safety and efficacy and to support registration of such products. Implements specifically allocated clinical studies worldwide by being responsible for the Protocol, Investigator selections, Investigator Brochure and by writing/reviewing Expert Report for regulatory purposes. Ensures high quality of studies completed in a timely fashion. Supports marketing and business development.
KEY TASKS AND RESPONSIBILITIES
§ In association with the Head of the GCDU directs the global Fertility programs and personnel. In addition acts as the site administrator for all Rockland/Geneva based Fertility GCDU personnel.
§ Responsible as a member of the Implementation Team for all medical & scientific aspects of the study from design phase, through implementation, and finalization, including scientific and medical input into the final review and sign-off of all pertinent clinical trial documentation.
§ Responsible for assuring that study conduct is in compliance with all applicable national, and internationally accepted regulations.
§ Review clinical research proposals within the therapeutic area for medical and scientific merit.
§ Ensure publication plans and publication contents are scientifically and medically valid and compatible with the strategic messages of the TA
§ Attend scientific and pharmaceutical and biotech industry meetings to remain abreast of new developments within the TA, and new developments in clinical research methodologies |
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Medical degree
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7 years + |
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French : Speak Well
German : Speak Well
English : Speak / Write Fluently
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open-ended |
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unspecified |
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International |
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Geneva |
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Fluent in English. Fluency in French and German is an asset.
M.D. specialized in the relevant Therapeutic Area (Obstetrics & Gynecology with subspecialty in Reproductive Endocrinology or Internal Medical with subspecialty in Endocrinology and interest in inferitly) with experience in clinical research
Minimum of 6 years experience in pharmaceutical product development (industry experience) or significant academic medicine experience involving drug development (phase I - IV), regulatory experience as a consultant and international experpertise in therapeutic area
At lease 5 years management experience in industry or medical/academic practice
Medical pharmaceutical publication experience
Working knowledge in GCP and ICH guidelines/practices
Demostrated writing abilities as note in the CV with list of accepted publication in peer review journals
Ability to build and work with teams
Excellent skills in leading, driving and managing large cross-functional teams
Good communication skills
Ability to work in a Matrix organisation environment |
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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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