Roche is recruiting for a Lead Medical Director to join our neuroscience clinical development team based in Basel headquarters to support the ongoing late-stage development of our MS product. In this role, you will have the opportunity to make major contributions to the development of the clinical development plan for assigned molecule(s)/indication(s)

This role is ideal for a board-certified neurologist with an in-depth knowledge of all phases of late-stage drug development (Phase II-III) and broad scientific and therapeutic expertise. You will also have the opportunity to work on a paediatric development plan.

You will be responsible for:

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• Leading design, development, and execution of clinical studies and play an active role in health authority (HA) interactions providing clinical science information such as the development of briefing packages and responses to HA questions with little to no supervision from more experienced Medical Directors

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• Collaborating with others in the development of product safety profiles, clinical sections of investigator brochures, presentations and other materials

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• Collaborating with relevant team members to measure and monitor study progress against objectives and plans, including any variances, and proactively communicates any issues, challenges and potential strategies to resolve such

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• Taking an active role with other CST members, regulatory and other internal partners/stakeholders in completing and submitting regulatory filings and other regulatory documentation.

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• Providing clinical science information and input for regulatory submissions and other regulatory processes. Includes developing label and packaging language, etc.

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• Collaborating with relevant team members and clinical operations to close out clinical studies, secure data and complete study reporting

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• Acting as a medical monitor for assigned studies or delegates this responsibility appropriately

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You will bring the following profile and expertise:

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• MD and board certificate in Neurology is a must along with relevant clinical, scientific, and clinical trial/development experience in the same/similar therapeutic area

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• 4 or more years of pharma/biotech industry experience with significant experience designing and conducting clinical trials (i.e. one or more trials) specifically Phase II \\xe2\\x80\\x93 III drug development. Experience in pediatric drug development is a plus

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• Experience authoring a global development plan as well as significant experience working with the principles and techniques of data analysis, interpretation, and clinical relevance

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• Experience publishing results of a scientific study in a peer-reviewed journal is preferred

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• Regulatory: Knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, and other relevant guidelines and regulations is required

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At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\\xe2\\x80\\x99ve become one of the world\\xe2\\x80\\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.