Lead Medical Director, Product Development, CVRM

Roche • Boston, MA

80d • $213,000 - $396,000

About The Position

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. Roche is looking for a medical director to join the Neuroimmunology Team within the Neurology Therapeutic Area. Specific experience in multiple sclerosis is required. 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 participate in the design, development and execution of clinical studies. You will act as a medical monitor for assigned studies. You will collaborate with a variety of internal/external partners & stakeholders, as well as multidisciplinary internal groups, including business development, research, commercial, legal, etc. You may 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 understanding of Phase II - III drug development. You will 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; you will provide clinical science information and input for regulatory submissions and other regulatory processes. You will help support the strategic and operational alignment of the CD plan with the relevant CD strategy, Asset team priorities and goals; 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.)

Requirements

• MD/MBBS; board-certified training (or its equivalent) in endocrinology and/or substantial cardiovascular, metabolic, diabetes specific research and clinical experience
• 4+ years of post-grad relevant clinical/scientific research and/or clinical trial experience
• Significant experience working with the principles and techniques of data analysis, interpretation and clinical relevance
• Demonstrated experience in scientific writing (e.g. manuscripts, grants, scientific protocols)
• Outstanding communication skills in both long-form scientific presentation and short-form communication of complex scientific topics

Nice To Haves

• Knowledge of the pharma/biotech industry and the drug development process
• Demonstrated experience working with various clinical trial designs (e.g. accelerated approval, pivotal, breakthrough)
• Ability to collaborate with team members to measure and monitor study progress against objectives
• Strong interpersonal skills and ability to influence internal partners and stakeholders

Responsibilities

• Support the development and implementation of the Clinical Development Plan (CDP) for assigned molecule(s)/indication(s)
• Gather and analyze 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 internal/external partners & stakeholders
• Provide clinical science input & guidance for early development/Phase I studies
• Review and provide late stage input to Phase I & II protocols
• Take an active role in the completion and submission of regulatory filings
• Provide clinical science information and input for regulatory submissions
• Support the strategic and operational alignment of the CD plan with relevant strategies and goals
• Develop CD plan components such as analytics/data strategy, KOL development, publications strategy

Benefits

• Relocation benefits offered
• Discretionary annual bonus based on individual and Company performance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees