Medical Director, Product Development, CVRM - Tuusula

Job summary

We advance science so that we all have more time with the people we love. Roche's Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients.

Responsibilities

• You will act as a medical monitor for assigned studies
• You will support the development and implementation of the Clinical Development Plan (CDP) for assigned molecule(s)/indication(s); gathering and analyzing data and information necessary to create the CD plan.
• You will collaborate with a variety of internal/external partners & stakeholders, as well as multidisciplinary internal groups, including business development, research, commercial, legal, etc and act as a subject matter expert and medical expert for trial related issues and events, health authority interactions, liaison with key opinion leaders in the area and provide publications support.
• You will participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input & guidance; including reviewing and providing late-stage input to Phase I & II protocols.
• You have a demonstrated experience of Phase II - III drug development.
• You will take an active role with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Provides clinical science information and input for regulatory submissions and other regulatory processes. Includes developing label and packaging language, etc.
• You will be responsible to ensure strategic and operational alignment of the CD plan with the relevant CD strategy, strategic and annual LCP; you will work with other CST members and relevant sub-teams to develop CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.)

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