Principal Medical Director, Product Development, CVRM

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The Opportunity

Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development clinical strategies and plans that deliver medically differentiated therapies that provide meaningful improvement to patients. 

Roche is looking for an experienced and highly specialized individual to join the Cardiovascular, Renal, and Metabolism group. The role of Principal Medical Director will focus on guiding the development of our CVRM portfolios. The ideal candidate will have extensive experience in late stage drug development and managing large-scale clinical trials, including outcoming studies.

The Principal Medical Director will have strong collaboration with cross-functional teams, including clinical research, regulatory affairs, and product development, to ensure the successful progression of treatments through the pipeline and into the market. The position would also require a strong understanding of cardiovascular diseases, clinical trial protocols, regulatory requirements, and possibly interactions with regulatory agencies to ensure studies meet the required standards. 

The Principal Medical Director leads development of the Clinical Development (CD) strategy and is responsible for developing the CD plan and ensuring effective and efficient execution for assigned  molecule(s)/indication(s). Principal Medical Directors are expected to act as CD leaders, perform their responsibilities independently, and effectively lead multiple projects. Principal Medical Directors may be assigned CD strategy development and implementation oversight for an entire brand or franchise.

• You will interact with the highest levels of management and experts both internally and externally, serving as internal consultants to Roche committees as well as representing the therapeutic area’s CD strategy, plans, objectives and interests to health authorities (HAs) and prominent thought leaders.

• You are expected to provide critical insights and contributions to the overall development and effectiveness of the assigned therapeutic area(s), including  therapeutic area scientific strategies and plans. .

• You have demonstrated a high level of experience in Clinical Development Plan (CDP) Strategy & Planning, CDP Execution, Regulatory Activities, and Cross-Functional Team Leadership.

• You will  mentor other physicians / scientists in their disease area of expertise.

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Who You Are

(Required)

• You have an MD, MBBS or MD (MBBS)/PhD; along with significant clinical trial/late stage development experience; preferably in CVRM studies

• You have 8+ years of pharma/biotech R&D experience,

• You have experience authoring global clinical development plans and working with various health authorities; (i.e. have led successful interactions with the FDA, EMA and other health authorities, including a filing.)

• You have extensive understanding of Phase II – III drug development (e.g trials across different stages of development, or formal education/qualifications in pharmaceutical medicine or drug development); have made significant contributions to an organization’s drug development (whether at Roche or another organization); have identified and created clinical development strategies that have led to label-enabling outcomes

• You have significant regulatory experience: providing clinical science information and input for regulatory submissions and other regulatory process: experience leading/overseeing others in development of briefing packages by providing clinical science information and input; experience leading/overseeing others in development of interactions and responses to health authority (HA) questions by providing clinical science information and input; other team members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation

Preferred

• Board eligible/board certified in cardiology or endocrinology is preferred

• You have in-depth knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process.

• You have championed novel/innovative approaches to clinical development (i.e. study design, endpoints, technology)

• You have the ability to collaborate on enterprise level strategic initia