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Roche

(Senior) Medical Director Huntington’s disease

  

The (Senior) Medical Director participates in development of the Clinical Development (CD) strategy and is responsible for developing the CD plan and ensuring effective and efficient CD plan execution for the HTT ASO program interacting with a variety of internal and external stakeholders. (Senior) Medical Directors are expected to perform their responsibilities with more independence by comparison to Associate PD Medical Directors, including participating in health authority (HA) interactions with little to no supervision from their managers when needed.  

  • You collaborate with a variety of internal and external partners and stakeholders, such as clinical investigators, therapeutic area experts (TAEs), regulators, as well as multidisciplinary internal groups, including other groups in PD research, business development, commercial operations, legal, etc., to execute the clinical development strategy.  

  • You collaborate with and assist the Global Development Lead and Clinical Science leader in all clinical development areas to form development strategy and execute it with a team-oriented mindset.

  • You participate in and/or lead the Clinical Science Team (CST) to enable effective and efficient CD plan execution.

  • You represent clinical development on various sub-teams or other appropriate forums, including assisting in site selection for studies, acting as a primary point-of-contact for questions and inquiries to development on your study/program

  • You play a lead role on interpretation of study results and in the development and implementation of communications strategies to support existing and concluded studies, including developing and delivering key presentations.

  • You have regular external interactions with cooperative groups, therapeutic area experts, vendors, partners to ensure investigators are appropriately and thoroughly briefed, in a timely manner, on medical/scientific matters relating to each study, and also participate in external interactions with health authorities.

  • You stay abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the HTT ASO program

  • You ensure GCP, Clinical Operating Guidelines and Standard Operating Procedures are followed 

Qualifications and experience:

  • M.D. with relevant medical experience in Huntington’s disease therapeutic area required including movement disorders fellowship training

  • 4 or more years pharma/biotech industry experience, 4 or more years experience with clinical trials. In-depth understanding of Phase II – III drug development

  • Experience submitting an NDA/BLA to regulatory authorities in Europe and/or the U.S. is preferred, experience authoring aspects of a global clinical development plan or full clinical study protocol is preferred 

  • Experience publishing results of a clinical drug trial in a referred journal is preferred. Academic/teaching background is a plus

  • Knowledge/understanding of Phase I & IV drug development is a plus 

  • Experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.) 

  • Comprehensive understanding of product and safety profiles 

  • Clinical leadership: is regarded as an expert in his/her field, is respected by others, can effectively contribute to longer-range drug development, and can lead cross-functional teams to successful results 

  • Strong interpersonal, verbal communication (including presentation skills) and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally 

  • Ability to travel globally (<30%) 

  

Roche is an equal opportunity employer.

Medical Affairs, Medical Affairs > Medical Information/Scientific Affairs

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