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| Senior Medical Director, GEDU Oncology |
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PURPOSE OF THE ROLE
•Act as transmission belt between Research and Development andfor asmooth transition to early clinical and full development
•Act as director of early clinical development strategies
•Act as the leader of a Clinical Development Team (CDT)
•Act as a Global Project Team (GPT) clinical representative
•May act as manager of Medical Directors as assigned
•Provide medical andscientific expertise/input to Business Development activities, to Discovery and Non-Clinical Development, to Stratified Medicine, Preclinical Pharmacology, Medical Communications, oncology TA research, quality assurance, global clinical operations, biostatistics, global regulatory affairs and Global Drug Safety
•Be medical responsible for a study
•Support business development activities by coordinating the scientific input to In-/Out-Licensing opportunities
•Participate in Due Diligence activities and prepare Due Diligence Reports
KEY TASKS AND RESPONSABILITIES
Functional Tasks
•Act as transmission belt between Research and Development:
◦Drive the development and creation of Clinical Development Plan and contribute to Discovery Reports (DP0 Report)
◦Provide clinical research expertise to Discovery Project Teams from DPHD to DP0 and contribute to the definition of a clear path to First-In-Man and Proof-of-Concept including advise on biomarker and differentiation.
•Act as director of early clinical development strategies:
◦Develop (or support development) and propose the early Clinical Development Plan, including PoC strategies, for assigned product(s)
◦Provide medical/scientific input and drive the creation of relevant clinical documents or parts thereof to ensure high quality of e.g. study concept sheets, study protocols and reports, Investigator Brochures, submission/registration documents, publications, etc.
◦Review and sign off all clinical documents related to First-In-Patients and PoC studies (e.g. study protocols and study reports)
◦Supervise the review, analysis and interpretation of study data
◦Support communication of study results as assigned
•Act as the leader of the Clinical Development Team:
◦Drive execution of early clinical development strategies for assigned product(s) in order to establish a clear path path to First-In-Man and Proof-of-Concept and related Go/No Go criteria
◦Drive and support the development and preparation of early clinical development plans, study concept sheets, and study protocols in collaboration with clinical and project team members
◦Responsible for the medical supervision of assigned product(s) and studie(s)
•Act as a Global Project Team representative:
◦Participate in cross-functional development project team activities to provide medical/scientific input into e.g. business plan, project strategy, in-/out-licensing activities, etc. as assigned
◦Liaise with (principal) investigators, health authorities, IEC/IRB, consultants, opinion/thought leaders and academic institutions within area of responsibility
Managerial Tasks
•Act as manager of Medical Directors as assigned:
◦Supervise, manage and mentor subordinate Medical Directors, possibly at different sites, in alignment with corporate values
◦Increase scientific knowledge by organizing development activities, such as internal courses, invitation of external speakers, etc.
◦Support/Contribute to annual budget and resource planning |
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Medical degree
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15 years + |
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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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•Medical Doctor (MD) specialized in the therapeutic area
•Global recognition as expert in clinical drug development with sound knowledge in early development, including pharmacogenomics and pharmacokinetics
•Fluency in English
•A minimum of 5 years experience in clinical research/development as investigator and/or within the pharmaceutical and/or biotech industry at an international level
•Extensive experiences in interaction with Health Authorities in Europe, US and possibly Japan and/or China
•In-depth knowledge of ICH-GCP and other applicable regulatory guidelines/practices
•Ability to work and manage people in a matrix environment
•Willingness to travel frequently (domestic and intercontinental) |
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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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