Lead Medical Director, Product Development, CVRM - Tuusula

Job summary

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

• 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; participate in the design, development and execution of clinical studies.

• Act as a medical monitor for assigned studies.

• Collaborate with a variety of internal/external partners & stakeholders, as well as multidisciplinary internal groups, including business development, research, commercial, legal, etc.

• 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.

• Take an active role with other Clinical Science Team (CST) members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation; provide clinical science information and input for regulatory submissions and other regulatory processes.

• Help support the strategic and operational alignment of the CD plan with the relevant CD strategy, Asset team priorities and goals; work with other CST members and relevant sub-teams to develop CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.).

Qualifications

• Have an MD/MBBS; board-certified training (or its equivalent) in endocrinology and/or substantial cardiovascular, metabolic, diabetes specific research and clinical experience.

• Have 4+ years of post-grad relevant clinical/scientific research and/or clinical trial experience.

• Have significant experience working with the principles and techniques of data analysis, interpretation and clinical relevance and demonstrated experience in scientific writing (e.g. manuscripts, grants, scientific protocols).

• Have outstanding communication skills in both long-form scientific presentation and short-form communication of complex scientific topics.

Työn kuvaus