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| Medical Director, CMO Office |
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To support and advise the Chief Medical Officer (CMO) on the implementation, maintenance and improvement of the Medical Governance system for Merck.
To support and advise the CMO on content oriented tasks and activities pertaining to the Concept Sheet Review Committee as well as to the Global Safety and Ethics Committee.
Key Tasks and Responsibilities
Medical Governance
To contribute to the establishment, maintenance and continuous improvement of a medical governance structure and processes, with particular immediate emphasis on the following complex processes:
Compassionate use, product donation, early access and expanded programs
Clinical trial design posting and clinical trial results disclosure
Interaction and communication with local medical functions and support them for the development of their quality system in relation to medical governance
Training on these processes
Trial results internal communication.
To monitor processes that have the CMO in the escalation path (such as MARC, Crisis and crisis communication plan, medical alert, integration risk management plans, Product information committee and introduction of new product within Merck Serono procedure).
To support the CMO in the Product Crisis Plan and Crisis Communication Plan execution when crisis potentially affects patient's safety or requires protection.
To manage the twenty-four hour medical coverage process.
To ensure the follow up of these processes, detect deviations and functioning issues and propose corrective actions.
Concept Sheet Review Committee (CSRC)
To review Concept Sheet (CS) and relevant documentation in advance to the CSRC meeting and prepare comments
To support the trial and project team with follow up of action, post CSRC meeting, and ensure that the final protocol is developed in compliance with the approved CS
To collect, compile, analyze, summarize the feed back received from Ethics Committees and Health Authorities post submission of final protocols
To track protocol amendments and provide lessons learned from them.
To provide quarterly report on activities from the CSRC
Global Safety and Ethics Committee (GSEC)
To review documentation provided in support to first-in-man and first in pediatrics, or other documentation prior to GSEC meeting
To support the trial and project team with follow up of action, post GSEC meeting
Clinical Trial Results
To review results in the light of the history of the trial design development, from concept sheet to final protocol and subsequent amendments and provide lessons learned as appropriate |
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Medical degree
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10 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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EU National |
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Geneva |
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Medical degree (MD or equivalent) with profound management experience (at least 10 years) in drug development
Excellent oral and written communication skills in English
French or German is desirable
Excellent understanding of relevant regulatory guidelines (e.g. ICH, FDA, EMEA) and Good Clinical Practice
Well versed with the clinical regulatory guidelines/requirements specific to applicable therapeutic areas and their implications e.g., for statistical analysis
Strong project management, process improvement abilities, and the ability to mentor and coach people
Demonstrated experience in clinical research, including global program design and execution
Experience with global regulatory authorities in major markets
Good understanding of value potential and opportunities of clinical trial management especially of practical aspects in clinical research
Ability to adjust clinical trial designs
Ability to analyze, interpret, present and publish clinical study results
Knowledgeable in the overall pharmaceutical value chain and the impact of clinical trial management
Self-directed, technically strong, and a recognized leader maintaining a strategic perspective with regards to clinical and methodological development
Strong leadership and coaching competencies
Strong communication, negotiation and issue resolution as well as conflict management skills
Strong interpersonal skill
Ability to integrate multidisciplinary groups
Ability to work in a matrix organization
Excellent organization and prioritization skills
Excellent problem solving and consensus skills
Ability to accept and manage cultural differences
Excellent team player |
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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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