Medical Director, Product Development, CVRM

Genentech • Boston, MA

12d • Onsite

About The Position

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. The Medical Director participates in development of the Clinical Development (CD) strategy and plan and is responsible for effective and efficient execution for the assigned molecule(s)/indication(s). The Opportunity 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. Within the franchise there is a seamless end-to-end model of collaboration with a very close liaison between early and late-stage functions. 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.)

Requirements

• MD/MBBS; board-certified training (or its equivalent) in endocrinology and/or substantial cardiovascular, metabolic, diabetes specific research and clinical experience
• 2+ 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 and 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
• Demonstrated experience of Phase II - III drug development.

Nice To Haves

• Knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process.
• Demonstrated experience working with various clinical trial designs, (e.g. accelerated approval, pivotal, breakthrough etc)
• Ability to collaborate with relevant team members to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve such
• Strong interpersonal skills: Outstanding interpersonal, verbal, and written communication and influencing skills: has built and cultivated important relationships both inside an organization and externally. Has proven abilities to influence internal partners and stakeholders, thought leaders, national advocacy organizations, national standard-setting bodies, and other relevant external parties. Seamlessly collaborates with colleagues/other parts of the organization.

Responsibilities

• Act as a medical monitor for assigned studies
• 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.
• 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.
• 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 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. Includes developing label and packaging language, etc.
• 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.)

What This Job Offers

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